Download PDF

Clinical Trial Results:
A Randomized, Double-blind, Placebo-and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks Alone and in Combination with Methotrexate (MTX) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy

Summary
EudraCT number	2016-000570-37
Trial protocol	SK BE GB HU DE CZ ES PL BG
Global end of trial date	08 May 2019

Results information
Results version number	v2(current)
This version publication date	21 May 2021
First version publication date	24 May 2020
Other versions	v1
Version creation reason	New data added to full data set Added additional secondary endpoints.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GS-US-417-0303

ISRCTN number

US NCT number

NCT02886728

WHO universal trial number (UTN)

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

333 Lakeside Drive, Foster City, CA, United States, 94404

Public contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Scientific contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

08 May 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

05 Oct 2018

Global end of trial reached?

Yes

Global end of trial date

08 May 2019

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 24.

Protection of trial subjects

The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Aug 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Slovakia: 8

Country: Number of subjects enrolled

South Africa: 19

Country: Number of subjects enrolled

Spain: 34

Country: Number of subjects enrolled

Taiwan: 23

Country: Number of subjects enrolled

Thailand: 13

Country: Number of subjects enrolled

Ukraine: 69

Country: Number of subjects enrolled

United Kingdom: 8

Country: Number of subjects enrolled

United States: 319

Country: Number of subjects enrolled

Argentina: 40

Country: Number of subjects enrolled

Australia: 18

Country: Number of subjects enrolled

Belgium: 19

Country: Number of subjects enrolled

Bulgaria: 54

Country: Number of subjects enrolled

Canada: 21

Country: Number of subjects enrolled

Chile: 14

Country: Number of subjects enrolled

Czech Republic: 20

Country: Number of subjects enrolled

Germany: 30

Country: Number of subjects enrolled

Hong Kong: 3

Country: Number of subjects enrolled

Hungary: 18

Country: Number of subjects enrolled

India: 116

Country: Number of subjects enrolled

Ireland: 2

Country: Number of subjects enrolled

Israel: 2

Country: Number of subjects enrolled

Italy: 3

Country: Number of subjects enrolled

Japan: 71

Country: Number of subjects enrolled

Korea, Republic of: 24

Country: Number of subjects enrolled

Malaysia: 6

Country: Number of subjects enrolled

Mexico: 116

Country: Number of subjects enrolled

New Zealand: 16

Country: Number of subjects enrolled

Poland: 109

Country: Number of subjects enrolled

Romania: 10

Country: Number of subjects enrolled

Russian Federation: 31

Country: Number of subjects enrolled

Serbia: 16

Worldwide total number of subjects

1252

EEA total number of subjects

315

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

997

From 65 to 84 years

253

85 years and over

Subject disposition

Top of page

Recruitment details

Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.

Screening details

1855 participants were screened.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Filgotinib 200 mg + MTX

Arm description

Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Arm type

Experimental

Investigational medicinal product name

Filgotinib

Investigational medicinal product code

Other name

GS-6034, GLPG0634

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200 mg administered once daily

Investigational medicinal product name

Placebo to match (PTM ) filgotinib 100 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

PTM filgotinib 100 mg administered once daily

Investigational medicinal product name

MTX

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Up to 20 mg administered once weekly

Filgotinib 100 mg + MTX

Arm description

Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Arm type

Experimental

Investigational medicinal product name

Filgotinib

Investigational medicinal product code

Other name

GS-6034, GLPG0634

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

100 mg administered once daily

Investigational medicinal product name

PTM filgotinib 200 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

PTM filgotinib 200 mg administered once daily

Investigational medicinal product name

MTX

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Up to 20 mg administered once weekly

Filgotinib 200 mg Monotherapy

Arm description

Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

Arm type

Experimental

Investigational medicinal product name

Filgotinib

Investigational medicinal product code

Other name

GS-6034, GLPG0634

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200 mg administered once daily

Investigational medicinal product name

PTM filgotinib 100 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

PTM filgotinib 100 mg administered once daily

Investigational medicinal product name

PTM MTX

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

PTM MTX capsules administered once weekly

MTX Monotherapy

Arm description

Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

Arm type

Experimental

Investigational medicinal product name

PTM filgotinib 200 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

PTM Filgotinib 200 mg administered once daily

Investigational medicinal product name

PTM filgotinib 100 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

PTM Filgotinib 100 mg administered once daily

Investigational medicinal product name

MTX

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Up to 20 mg administered once weekly

Number of subjects in period 1 ^[1]	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Started	416	207	210	416
Completed	345	175	174	331
Not completed	71	32	36	85
Withdrew Consent	31	13	11	47
Adverse Event	13	5	5	11
Non-Compliance with Study Drug	1	-	1	-
Death	3	1	-	-
Pregnancy	-	-	1	-
Protocol Violation	-	-	-	4
Lost to follow-up	12	6	13	12
Investigator`s Discretion	11	7	5	11

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Three participants who were randomised but did not receive the study drug are not included in analysis.

Baseline characteristics

Top of page

Reporting group title

Filgotinib 200 mg + MTX

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 100 mg + MTX

Reporting group description

Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 200 mg Monotherapy

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

Reporting group title

MTX Monotherapy

Reporting group description

Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

Reporting group values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy	Total
Number of subjects	416	207	210	416	1249
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	53 ( 13.8 )	54 ( 12.6 )	52 ( 13.9 )	53 ( 13.7 )	-
Gender categorical
Units: Subjects
Female	325	158	166	312	961
Male	91	49	44	104	288
Race
Not Permitted = local regulators did not allow collection of race information.
Units: Subjects
American Indian or Alaska Native	26	12	18	33	89
Asian: Japanese	23	11	12	25	71
Asian: Chinese/Taiwanese/Hong Kong Chinese	7	4	6	10	27
Asian: Vietnamese	1	0	0	0	1
Asian: Korean	6	8	2	8	24
Asian: Other	53	28	27	42	150
Black or African American	15	8	8	14	45
Native Hawaiian or Pacific Islander	1	0	1	3	5
White	278	132	135	278	823
Other	6	4	0	3	13
Not Permitted	0	0	1	0	1
Ethnicity
Not Permitted = local regulators did not allow collection of ethnicity information.
Units: Subjects
Hispanic or Latino	93	40	45	84	262
Not Hispanic or Latino	322	167	165	332	986
Not Permitted	1	0	0	0	1

End points

Top of page

Reporting group title

Filgotinib 200 mg + MTX

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 100 mg + MTX

Reporting group description

Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 200 mg Monotherapy

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

Reporting group title

MTX Monotherapy

Reporting group description

Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

Primary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24

Top of page

End point title

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24

End point description

ACR20 response is achieved when the participant has: ≥20% improvement(reduction)from baseline in tender joint count based on 68 joints(TJC68),swollen joint count based on 66 joints(SJC66) and in at least 3 of the following 5 items:physician’s global assessment of disease activity(PGA) and subject’s global assessment of disease activity(SGA) assessed using visual analog scale(VAS) on a scale of 0-100(0 and 100 indicate no disease activity,maximum disease activity) participant`s pain assessment using VAS on a scale of 0-100 (0 and 100 indicate no pain,unbearable pain) health assessment questionnaire-disability index(HAQ-DI) score contains 20 questions, 8 components: dressing/grooming,arising,eating,walking,hygiene,reach,grip and activities and scored on a scale of 0-3 (0 and 3 indicate without difficulty and unable to do, respectively) high-sensitivity C-reactive protein(hsCRP). The Full Analysis Set included participants who were randomised and received at least 1 dose of study drug.

End point type

Primary

End point timeframe

Week 24

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)	81.0 (77.1 to 84.9)	80.2 (74.5 to 85.9)	78.1 (72.3 to 83.9)	71.4 (66.9 to 75.9)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[1]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.6

Confidence interval

level

95%

sides

2-sided

lower limit

3.6

upper limit

15.6

Notes
[1] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017 ^[2]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

8.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.5

upper limit

16.1

Notes
[2] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.058 ^[3]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

14.1

Notes
[3] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

Top of page

End point title

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

End point description

The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually administered by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Week 24

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=414,207,210,416)	1.52 ( 0.622 )	1.56 ( 0.654 )	1.56 ( 0.655 )	1.60 ( 0.625 )
Change at Week 24 (N=372,190,185,370)	-0.94 ( 0.722 )	-0.90 ( 0.675 )	-0.89 ( 0.631 )	-0.79 ( 0.634 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Least squares (LS)-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[4]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.19

Confidence interval

level

95%

sides

2-sided

lower limit

-0.27

upper limit

-0.11

Variability estimate

Standard error of the mean

Dispersion value

0.041

Notes
[4] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009 ^[5]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-0.23

upper limit

-0.03

Variability estimate

Standard error of the mean

Dispersion value

0.049

Notes
[5] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032 ^[6]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

-0.01

Variability estimate

Standard error of the mean

Dispersion value

0.05

Notes
[6] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)]< 2.6 at Week 24

Top of page

End point title

Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)]< 2.6 at Week 24

End point description

The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analysed.

End point type

Secondary

End point timeframe

Week 24

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)	54.1 (49.2 to 59.0)	42.5 (35.5 to 49.5)	42.4 (35.5 to 49.3)	29.1 (24.6 to 33.6)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[7]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

18.3

upper limit

31.7

Notes
[7] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

21.8

Notes
[8] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

21.6

Notes
[9] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24

Top of page

End point title

Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24

End point description

Participant`s radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0, 448]) is defined as the erosion score (range [0, 280]) plus the joint space narrowing (JSN) score (range [0, 168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating no/normal JSN and 4 indicating complete loss of joint space. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Week 24

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=410,204,204,408)	11.35 ( 19.922 )	13.31 ( 26.980 )	16.53 ( 32.372 )	13.72 ( 29.168 )
Change at Week 24 (N=355,184,173,356)	0.21 ( 1.684 )	0.22 ( 1.526 )	-0.04 ( 1.710 )	0.51 ( 2.887 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.068 ^[10]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.61

upper limit

0.02

Variability estimate

Standard error of the mean

Dispersion value

0.161

Notes
[10] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.14 ^[11]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.67

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

0.195

Notes
[11] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[12]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.55

Confidence interval

level

95%

sides

2-sided

lower limit

-0.94

upper limit

-0.16

Variability estimate

Standard error of the mean

Dispersion value

0.199

Notes
[12] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in mTSS at Week 52

Top of page

End point title

Change From Baseline in mTSS at Week 52

End point description

Participant`s radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet [where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion]). JSN is scored from 0 to 4 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Week 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=411,205,204,408)	11.31 ( 19.273 )	12.76 ( 24.363 )	15.89 ( 31.813 )	13.36 ( 27.736 )
Change at Week 52 (N=345,176,166,330)	0.31 ( 1.808 )	0.23 ( 1.111 )	0.33 ( 1.902 )	0.81 ( 3.089 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[13]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-1.03

upper limit

-0.27

Variability estimate

Standard error of the mean

Dispersion value

0.195

Notes
[13] - MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[14]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.63

Confidence interval

level

95%

sides

2-sided

lower limit

-1.09

upper limit

-0.16

Variability estimate

Standard error of the mean

Dispersion value

0.236

Notes
[14] - MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[15]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-1.14

upper limit

-0.19

Variability estimate

Standard error of the mean

Dispersion value

0.242

Notes
[15] - MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, and baseline value as fixed effects, and participants being the random effect.

Secondary: Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52

End point description

ACR50 response is achieved when the participant has: ≥ 50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analysed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 2	13.0 (9.6 to 16.3)	9.2 (5.0 to 13.4)	16.2 (11.0 to 21.4)	2.9 (1.2 to 4.6)
Week 4	29.3 (24.8 to 33.8)	20.8 (15.0 to 26.5)	25.7 (19.6 to 31.9)	9.4 (6.5 to 12.3)
Week 12	53.1 (48.2 to 58.0)	44.4 (37.4 to 51.5)	45.7 (38.7 to 52.7)	28.4 (23.9 to 32.8)
Week 24	61.5 (56.7 to 66.3)	57.0 (50.0 to 64.0)	58.1 (51.2 to 65.0)	45.7 (40.8 to 50.6)
Week 36	60.6 (55.8 to 65.4)	55.6 (48.5 to 62.6)	58.6 (51.7 to 65.5)	48.6 (43.6 to 53.5)
Week 52	62.3 (57.5 to 67.0)	59.4 (52.5 to 66.4)	61.4 (54.6 to 68.3)	48.3 (43.4 to 53.2)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[16]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.1

Confidence interval

level

95%

sides

2-sided

lower limit

6.2

upper limit

13.9

Notes
[16] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[17]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.7

upper limit

10.9

Notes
[17] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[18]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.3

Confidence interval

level

95%

sides

2-sided

lower limit

7.7

upper limit

18.9

Notes
[18] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[19]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

14.5

upper limit

25.4

Notes
[19] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.4

Confidence interval

level

95%

sides

2-sided

lower limit

4.8

upper limit

Notes
[20] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[21]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

16.3

Confidence interval

level

95%

sides

2-sided

lower limit

9.4

upper limit

23.2

Notes
[21] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[22]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

24.8

Confidence interval

level

95%

sides

2-sided

lower limit

18.1

upper limit

31.5

Notes
[22] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[23]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

16.1

Confidence interval

level

95%

sides

2-sided

lower limit

7.7

upper limit

24.5

Notes
[23] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[24]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

17.3

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

25.7

Notes
[24] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[25]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

15.9

Confidence interval

level

95%

sides

2-sided

lower limit

8.9

upper limit

22.8

Notes
[25] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[26]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.7

upper limit

Notes
[26] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[27]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.4

Confidence interval

level

95%

sides

2-sided

lower limit

3.9

upper limit

Notes
[27] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[28]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

5.1

upper limit

Notes
[28] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.09 ^[29]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

15.7

Notes
[29] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.014 ^[30]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

18.6

Notes
[30] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[31]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.9

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

20.9

Notes
[31] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[32]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.1

Confidence interval

level

95%

sides

2-sided

lower limit

2.5

upper limit

19.7

Notes
[32] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[33]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.1

Confidence interval

level

95%

sides

2-sided

lower limit

4.6

upper limit

21.6

Notes
[33] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52

End point description

ACR70 response is achieved when the participant has: ≥ 70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analysed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 2	3.1 (1.3 to 4.9)	1.9 (0.0 to 4.0)	4.3 (1.3 to 7.3)	0.7 (0.0 to 1.7)
Week 4	13.0 (9.6 to 16.3)	6.3 (2.7 to 9.8)	11.4 (6.9 to 16.0)	3.8 (1.9 to 5.8)
Week 12	32.9 (28.3 to 37.6)	27.1 (20.8 to 33.3)	29.0 (22.7 to 35.4)	13.2 (9.8 to 16.6)
Week 24	43.8 (38.9 to 48.6)	40.1 (33.2 to 47.0)	40.0 (33.1 to 46.9)	26.0 (21.6 to 30.3)
Week 36	45.9 (41.0 to 50.8)	37.2 (30.4 to 44.0)	39.5 (32.7 to 46.4)	32.2 (27.6 to 36.8)
Week 52	47.8 (42.9 to 52.8)	40.1 (33.2 to 47.0)	45.2 (38.3 to 52.2)	29.8 (25.3 to 34.3)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.018 ^[34]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

4.5

Notes
[34] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.17 ^[35]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

3.6

Notes
[35] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[36]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

3.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

6.8

Notes
[36] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[37]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.1

Confidence interval

level

95%

sides

2-sided

lower limit

5.2

upper limit

13.1

Notes
[37] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.18 ^[38]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

6.6

Notes
[38] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[39]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.6

Confidence interval

level

95%

sides

2-sided

lower limit

2.5

upper limit

12.6

Notes
[39] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[40]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

19.7

Confidence interval

level

95%

sides

2-sided

lower limit

13.9

upper limit

25.5

Notes
[40] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[41]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.8

Confidence interval

level

95%

sides

2-sided

lower limit

6.6

upper limit

21.1

Notes
[41] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[42]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

15.8

Confidence interval

level

95%

sides

2-sided

lower limit

8.5

upper limit

23.1

Notes
[42] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[43]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

17.8

Confidence interval

level

95%

sides

2-sided

lower limit

11.2

upper limit

24.4

Notes
[43] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[44]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.1

Confidence interval

level

95%

sides

2-sided

lower limit

5.9

upper limit

22.4

Notes
[44] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[45]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

5.8

upper limit

22.2

Notes
[45] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[46]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.9

upper limit

20.5

Notes
[46] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2 ^[47]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

13.3

Notes
[47] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.056 ^[48]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

15.7

Notes
[48] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[49]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

11.3

upper limit

24.8

Notes
[49] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[50]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.9

upper limit

18.6

Notes
[50] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[51]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

15.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

23.8

Notes
[51] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52

Top of page

End point title

Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52

End point description

ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analysed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 2	42.1 (37.2 to 46.9)	37.2 (30.4 to 44.0)	39.5 (32.7 to 46.4)	16.6 (12.9 to 20.3)
Week 4	62.3 (57.5 to 67.0)	55.6 (48.5 to 62.6)	52.4 (45.4 to 59.4)	33.4 (28.8 to 38.1)
Week 12	76.7 (72.5 to 80.9)	72.0 (65.6 to 78.3)	71.4 (65.1 to 77.8)	59.4 (54.5 to 64.2)
Week 36	75.5 (71.2 to 79.7)	73.4 (67.2 to 79.7)	76.2 (70.2 to 82.2)	68.3 (63.7 to 72.9)
Week 52	75.0 (70.7 to 79.3)	73.4 (67.2 to 79.7)	74.8 (68.6 to 80.9)	61.8 (57.0 to 66.6)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[52]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

25.5

Confidence interval

level

95%

sides

2-sided

lower limit

19.3

upper limit

31.7

Notes
[52] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[53]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

20.6

Confidence interval

level

95%

sides

2-sided

lower limit

12.8

upper limit

28.5

Notes
[53] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[54]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

22.9

Confidence interval

level

95%

sides

2-sided

lower limit

15.1

upper limit

30.8

Notes
[54] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[55]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

28.8

Confidence interval

level

95%

sides

2-sided

lower limit

22.1

upper limit

35.6

Notes
[55] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[56]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

22.1

Confidence interval

level

95%

sides

2-sided

lower limit

13.6

upper limit

30.7

Notes
[56] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[57]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

10.5

upper limit

27.5

Notes
[57] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[58]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

17.3

Confidence interval

level

95%

sides

2-sided

lower limit

10.8

upper limit

23.8

Notes
[58] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[59]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.6

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

20.7

Notes
[59] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[60]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

20.1

Notes
[60] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016 ^[61]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

13.5

Notes
[61] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.18 ^[62]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

5.2

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

Notes
[62] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.03 ^[63]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

15.6

Notes
[63] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[64]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.2

Confidence interval

level

95%

sides

2-sided

lower limit

6.7

upper limit

19.7

Notes
[64] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[65]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.7

Confidence interval

level

95%

sides

2-sided

lower limit

3.7

upper limit

19.6

Notes
[65] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[66]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

5.1

upper limit

20.8

Notes
[66] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52

End point description

The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement (less disability). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=414,207,210,416)	1.52 ( 0.622 )	1.56 ( 0.654 )	1.56 ( 0.655 )	1.60 ( 0.625 )
Change at Week 2 (N=400,202,202,405)	-0.37 ( 0.495 )	-0.36 ( 0.490 )	-0.32 ( 0.442 )	-0.18 ( 0.426 )
Change at Week 4 (N=405,200,205,403)	-0.57 ( 0.587 )	-0.45 ( 0.547 )	-0.51 ( 0.526 )	-0.32 ( 0.511 )
Change at Week 12 (N=389,197,193,389)	-0.85 ( 0.698 )	-0.77 ( 0.670 )	-0.76 ( 0.625 )	-0.61 ( 0.582 )
Change at Week 36 (N=348,178,179,327)	-0.96 ( 0.725 )	-0.93 ( 0.700 )	-0.91 ( 0.673 )	-0.89 ( 0.675 )
Change at Week 52 (N=332,169,171,307)	-1.00 ( 0.728 )	-0.97 ( 0.719 )	-0.95 ( 0.688 )	-0.88 ( 0.685 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[67]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.23

Confidence interval

level

95%

sides

2-sided

lower limit

-0.29

upper limit

-0.17

Variability estimate

Standard error of the mean

Dispersion value

0.031

Notes
[67] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[68]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.28

upper limit

-0.13

Variability estimate

Standard error of the mean

Dispersion value

0.038

Notes
[68] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[69]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.24

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.038

Notes
[69] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[70]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.35

upper limit

-0.22

Variability estimate

Standard error of the mean

Dispersion value

0.035

Notes
[70] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[71]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-0.23

upper limit

-0.06

Variability estimate

Standard error of the mean

Dispersion value

0.043

Notes
[71] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[72]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.21

Confidence interval

level

95%

sides

2-sided

lower limit

-0.29

upper limit

-0.12

Variability estimate

Standard error of the mean

Dispersion value

0.042

Notes
[72] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[73]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-0.35

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.039

Notes
[73] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[74]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.18

Confidence interval

level

95%

sides

2-sided

lower limit

-0.28

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.048

Notes
[74] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[75]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

-0.07

Variability estimate

Standard error of the mean

Dispersion value

0.048

Notes
[75] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[76]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.13

Confidence interval

level

95%

sides

2-sided

lower limit

-0.22

upper limit

-0.05

Variability estimate

Standard error of the mean

Dispersion value

0.043

Notes
[76] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.23 ^[77]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-0.17

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.052

Notes
[77] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.24 ^[78]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.06

Confidence interval

level

95%

sides

2-sided

lower limit

-0.16

upper limit

0.04

Variability estimate

Standard error of the mean

Dispersion value

0.052

Notes
[78] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[79]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.17

Confidence interval

level

95%

sides

2-sided

lower limit

-0.25

upper limit

-0.08

Variability estimate

Standard error of the mean

Dispersion value

0.045

Notes
[79] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.077 ^[80]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.01

Variability estimate

Standard error of the mean

Dispersion value

0.054

Notes
[80] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.039 ^[81]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-0.22

upper limit

-0.01

Variability estimate

Standard error of the mean

Dispersion value

0.054

Notes
[81] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52

End point description

TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: tender joint count
arithmetic mean (standard deviation)
Baseline	26 ( 14.5 )	25 ( 13.9 )	26 ( 13.7 )	26 ( 13.8 )
Change at Week 2 (N=402,202,201,405)	-9 ( 10.2 )	-8 ( 9.8 )	-9 ( 11.2 )	-5 ( 9.8 )
Change at Week 4 (N=408,201,205,404)	-13 ( 12.1 )	-12 ( 10.1 )	-13 ( 11.8 )	-8 ( 11.5 )
Change at Week 12 (N=390,197,193,387)	-18 ( 12.5 )	-17 ( 12.4 )	-18 ( 12.4 )	-15 ( 12.2 )
Change at Week 24 (N=374,190,186,370)	-20 ( 12.5 )	-20 ( 13.0 )	-22 ( 12.4 )	-19 ( 12.9 )
Change at Week 36 (N=348,178,179,327)	-21 ( 12.6 )	-21 ( 12.8 )	-23 ( 11.9 )	-21 ( 12.7 )
Change at Week 52 (N=332,170,171,307)	-22 ( 12.4 )	-21 ( 13.0 )	-23 ( 12.3 )	-21 ( 12.6 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[82]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[82] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[83]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[83] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[84]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[84] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[85]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[85] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[86]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[86] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[87]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[87] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[88]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[88] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[89]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[89] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[90]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[90] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24; LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[91]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[91] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005 ^[92]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[92] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[93]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[93] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.063 ^[94]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[94] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.64 ^[95]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[95] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[96]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[96] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[97]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[97] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.095 ^[98]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[98] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[99]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[99] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52

End point description

The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: swollen joint count
arithmetic mean (standard deviation)
Baseline	16.0 ( 9.8 )	16.0 ( 9.3 )	16.0 ( 9.7 )	16.0 ( 9.4 )
Change at Week 2 (N=402,202,201,405)	-7.0 ( 8.0 )	-6.0 ( 6.9 )	-7.0 ( 8.1 )	-4.0 ( 7.5 )
Change at Week 4 (N=408,201,205,404)	-9.0 ( 8.7 )	-9.0 ( 7.6 )	-9.0 ( 8.3 )	-6.0 ( 9.2 )
Change at Week 12 (N=390,197,193,387)	-13.0 ( 8.9 )	-12.0 ( 8.1 )	-13.0 ( 9.1 )	-11.0 ( 8.9 )
Change at Week 24 (N=374,190,186,370)	-14.0 ( 8.9 )	-14.0 ( 8.8 )	-15.0 ( 9.5 )	-13.0 ( 8.8 )
Change at Week 36 (N=348,178,179,327)	-14.0 ( 9.1 )	-14.0 ( 9.4 )	-15.0 ( 9.7 )	-14.0 ( 8.7 )
Change at Week 52 (N=332,170,171,307)	-15.0 ( 9.2 )	-14.0 ( 8.9 )	-16.0 ( 9.8 )	-14.0 ( 9.0 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[100]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[100] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[101]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[101] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[102]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[102] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[103]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[103] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[104]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[104] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[105]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[105] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[106]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.4

Notes
[106] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[107]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[107] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[108]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.5

Notes
[108] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[109]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.3

Notes
[109] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[110]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.4

Notes
[110] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[111]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.4

Notes
[111] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[112]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.2

Notes
[112] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.12 ^[113]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.3

Notes
[113] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[114]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.3

Notes
[114] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[115]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.2

Notes
[115] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032 ^[116]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.3

Notes
[116] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[117]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.3

Notes
[117] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52

End point description

SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	65.0 ( 21.0 )	66.0 ( 21.6 )	68.0 ( 19.2 )	66.0 ( 21.0 )
Change at Week 2 (N=401,201,202,407)	-17.0 ( 20.8 )	-13.0 ( 18.9 )	-14.0 ( 20.7 )	-7.0 ( 18.9 )
Change at Week 4 (N=407,200,205,404)	-26.0 ( 24.7 )	-20.0 ( 22.5 )	-22.0 ( 24.6 )	-14.0 ( 22.2 )
Change at Week 12 (N=391,196,192,389)	-37.0 ( 26.7 )	-30.0 ( 26.1 )	-32.0 ( 27.7 )	-25.0 ( 25.9 )
Change at Week 24 (N=374,190,184,370)	-42.0 ( 26.8 )	-36.0 ( 27.4 )	-38.0 ( 26.6 )	-34.0 ( 27.4 )
Change at Week 36 (N=348,178,179,327)	-43.0 ( 27.2 )	-39.0 ( 27.8 )	-39.0 ( 24.3 )	-38.0 ( 28.0 )
Change at Week 52 (N=332,170,171,307)	-45.0 ( 27.0 )	-41.0 ( 28.1 )	-43.0 ( 25.4 )	-38.0 ( 28.3 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 200 mg + MTX

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[118]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-11

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

1.3

Notes
[118] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[119]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[119] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[120]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[120] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[121]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

-10

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[121] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[122]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[122] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[123]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[123] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[124]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

-9

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[124] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009 ^[125]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

Notes
[125] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[126]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

Notes
[126] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[127]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[127] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11 ^[128]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[128] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.066 ^[129]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[129] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[130]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[130] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4 ^[131]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[131] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.24 ^[132]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[132] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[133]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[133] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.17 ^[134]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[134] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[135]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[135] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52

End point description

PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	66.0 ( 17.0 )	68.0 ( 16.3 )	66.0 ( 14.4 )	67.0 ( 16.8 )
Change at Week 2 (N=397,200,201,401)	-24.0 ( 20.3 )	-21.0 ( 19.4 )	-23.0 ( 19.9 )	-15.0 ( 18.9 )
Change at Week 4 (N=402,201,198,402)	-34.0 ( 22.3 )	-32.0 ( 22.5 )	-30.0 ( 21.9 )	-23.0 ( 20.7 )
Change at Week 12 (N=388,196,192,385)	-47.0 ( 21.4 )	-43.0 ( 22.5 )	-42.0 ( 20.8 )	-38.0 ( 21.9 )
Change at Week 24 (N=372,187,185,364)	-51.0 ( 21.1 )	-51.0 ( 22.2 )	-49.0 ( 19.5 )	-46.0 ( 21.4 )
Change at Week 36 (N=347,177,178,324)	-53.0 ( 20.5 )	-51.0 ( 22.3 )	-52.0 ( 18.6 )	-51.0 ( 20.6 )
Change at Week 52 (N=332,169,171,307)	-56.0 ( 20.0 )	-54.0 ( 20.7 )	-55.0 ( 17.5 )	-51.0 ( 20.2 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[136]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

1.3

Notes
[136] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[137]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[137] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 200 mg Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[138]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[138] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[139]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-11

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[139] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[140]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[140] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[141]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[141] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[142]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

1.3

Notes
[142] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[143]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[143] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[144]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[144] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[145]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[145] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[146]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[146] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.046 ^[147]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[147] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[148]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[148] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.44 ^[149]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[149] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.21 ^[150]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[150] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 200 mg + MTX

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[151]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.1

Notes
[151] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.029 ^[152]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[152] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[153]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[153] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52

End point description

The participant assessed their pain severity using a VAS on a scale of 0 ( no pain) to 100 (severe pain). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=414,207,210,416)	64.0 ( 22.0 )	67.0 ( 22.1 )	67.0 ( 18.4 )	66.0 ( 21.4 )
Change at Week 2 (N=400,202,202,405)	-18.0 ( 22.2 )	-15.0 ( 20.3 )	-17.0 ( 21.6 )	-7.0 ( 20.1 )
Change at Week 4 (N=405,200,205,403)	-26.0 ( 24.8 )	-22.0 ( 23.7 )	-24.0 ( 25.3 )	-14.0 ( 23.6 )
Change at Week 12 (N=389,197,193,389)	-37.0 ( 27.1 )	-31.0 ( 26.9 )	-32.0 ( 28.3 )	-26.0 ( 27.0 )
Change at Week 24 (N=372,190,185,370)	-41.0 ( 28.0 )	-37.0 ( 27.8 )	-39.0 ( 26.1 )	-34.0 ( 27.6 )
Change at Week 36 (N=348,178,179,326)	-43.0 ( 28.0 )	-40.0 ( 28.8 )	-38.0 ( 25.6 )	-38.0 ( 29.3 )
Change at Week 52 (N=332,169,171,307)	-45.0 ( 27.9 )	-43.0 ( 27.9 )	-44.0 ( 24.2 )	-37.0 ( 30.5 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[154]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

-9

Variability estimate

Standard error of the mean

Dispersion value

1.4

Notes
[154] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[155]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[155] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[156]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[156] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[157]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-16

upper limit

-10

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[157] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[158]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.9

Notes
[158] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[159]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-13

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

1.9

Notes
[159] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[160]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[160] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[161]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[161] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[162]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[162] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[163]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[163] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.13 ^[164]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[164] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.047 ^[165]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[165] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[166]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

-4

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[166] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.34 ^[167]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[167] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.46 ^[168]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[168] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[169]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[169] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.03 ^[170]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-9

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.2

Notes
[170] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[171]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

2.2

Notes
[171] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52

End point description

Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: mg/L
arithmetic mean (standard deviation)
Baseline	18.04 ( 25.289 )	17.72 ( 27.419 )	17.32 ( 23.228 )	16.86 ( 24.353 )
Change at Week 2 (N=404,200,204,400)	-12.89 ( 23.401 )	-9.40 ( 18.930 )	-10.97 ( 20.249 )	-0.99 ( 14.392 )
Change at Week 4 (N=404,200,203,402)	-13.79 ( 23.569 )	-11.53 ( 20.596 )	-10.95 ( 23.319 )	-3.18 ( 18.534 )
Change at Week 12 (N=388,196,190,383)	-13.77 ( 23.585 )	-11.02 ( 20.272 )	-12.04 ( 24.690 )	-7.23 ( 21.823 )
Change at Week 24 (N=374,190,186,368)	-13.43 ( 27.086 )	-10.85 ( 24.458 )	-12.66 ( 24.525 )	-7.47 ( 23.511 )
Change at Week 36 (N=348,177,177,321)	-12.99 ( 26.823 )	-12.64 ( 22.736 )	-11.52 ( 26.863 )	-8.74 ( 23.579 )
Change at Week 52 (N=332,170,170,307)	-13.84 ( 25.180 )	-11.61 ( 23.857 )	-12.29 ( 23.090 )	-7.96 ( 23.835 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 200 mg + MTX

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[172]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10.78

Confidence interval

level

95%

sides

2-sided

lower limit

-12.71

upper limit

-8.85

Variability estimate

Standard error of the mean

Dispersion value

0.983

Notes
[172] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[173]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.76

Confidence interval

level

95%

sides

2-sided

lower limit

-11.13

upper limit

-6.39

Variability estimate

Standard error of the mean

Dispersion value

1.207

Notes
[173] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[174]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9.64

Confidence interval

level

95%

sides

2-sided

lower limit

-12

upper limit

-7.29

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[174] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[175]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9.92

Confidence interval

level

95%

sides

2-sided

lower limit

-11.65

upper limit

-8.19

Variability estimate

Standard error of the mean

Dispersion value

0.884

Notes
[175] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[176]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.34

Confidence interval

level

95%

sides

2-sided

lower limit

-10.47

upper limit

-6.21

Variability estimate

Standard error of the mean

Dispersion value

1.086

Notes
[176] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[177]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7.33

Confidence interval

level

95%

sides

2-sided

lower limit

-9.45

upper limit

-5.21

Variability estimate

Standard error of the mean

Dispersion value

1.08

Notes
[177] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[178]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.98

Confidence interval

level

95%

sides

2-sided

lower limit

-7.56

upper limit

-4.39

Variability estimate

Standard error of the mean

Dispersion value

0.808

Notes
[178] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[179]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.21

Confidence interval

level

95%

sides

2-sided

lower limit

-6.14

upper limit

-2.27

Variability estimate

Standard error of the mean

Dispersion value

0.987

Notes
[179] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[180]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.34

Confidence interval

level

95%

sides

2-sided

lower limit

-6.29

upper limit

-2.39

Variability estimate

Standard error of the mean

Dispersion value

0.993

Notes
[180] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[181]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.27

Confidence interval

level

95%

sides

2-sided

lower limit

-7.24

upper limit

-3.31

Variability estimate

Standard error of the mean

Dispersion value

1.003

Notes
[181] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[182]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.29

Confidence interval

level

95%

sides

2-sided

lower limit

-5.68

upper limit

-0.89

Variability estimate

Standard error of the mean

Dispersion value

1.222

Notes
[182] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[183]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.61

Confidence interval

level

95%

sides

2-sided

lower limit

-7.02

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

1.229

Notes
[183] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[184]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.44

Confidence interval

level

95%

sides

2-sided

lower limit

-5.35

upper limit

-1.53

Variability estimate

Standard error of the mean

Dispersion value

0.974

Notes
[184] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[185]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-5.72

upper limit

-1.09

Variability estimate

Standard error of the mean

Dispersion value

1.18

Notes
[185] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.072 ^[186]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.12

Confidence interval

level

95%

sides

2-sided

lower limit

-4.44

upper limit

0.19

Variability estimate

Standard error of the mean

Dispersion value

1.18

Notes
[186] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[187]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.79

Confidence interval

level

95%

sides

2-sided

lower limit

-6.34

upper limit

-3.24

Variability estimate

Standard error of the mean

Dispersion value

0.789

Notes
[187] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[188]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.01

Confidence interval

level

95%

sides

2-sided

lower limit

-4.88

upper limit

-1.13

Variability estimate

Standard error of the mean

Dispersion value

0.957

Notes
[188] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[189]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.77

Confidence interval

level

95%

sides

2-sided

lower limit

-5.65

upper limit

-1.89

Variability estimate

Standard error of the mean

Dispersion value

0.957

Notes
[189] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52

End point description

The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 2 (N=402,200,204,410)	61.9 (57.1 to 66.8)	58.5 (51.4 to 65.6)	53.9 (46.8 to 61.0)	42.2 (37.3 to 47.1)
Week 4 (N=402,200,204,410)	72.4 (67.9 to 76.9)	61.0 (54.0 to 68.0)	68.6 (62.0 to 75.2)	53.9 (49.0 to 58.8)
Week 12 (N=402,200,204,410)	80.3 (76.3 to 84.4)	74.5 (68.2 to 80.8)	74.0 (67.8 to 80.3)	69.8 (65.2 to 74.3)
Week 24 (N=402,200,204,410)	76.6 (72.4 to 80.9)	78.5 (72.6 to 84.4)	77.0 (70.9 to 83.0)	73.9 (69.5 to 78.3)
Week 36 (N=402,200,204,410)	73.4 (68.9 to 77.8)	76.5 (70.4 to 82.6)	73.5 (67.2 to 79.8)	67.1 (62.4 to 71.7)
Week 52 (N=402,200,204,410)	70.9 (66.3 to 75.5)	71.5 (65.0 to 78.0)	70.6 (64.1 to 77.1)	61.0 (56.1 to 65.8)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

MTX Monotherapy v Filgotinib 200 mg + MTX

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[190]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

19.7

Confidence interval

level

95%

sides

2-sided

lower limit

12.8

upper limit

26.7

Notes
[190] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[191]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

16.3

Confidence interval

level

95%

sides

2-sided

lower limit

7.6

upper limit

Notes
[191] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[192]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.7

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

20.4

Notes
[192] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[193]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.5

Confidence interval

level

95%

sides

2-sided

lower limit

11.7

upper limit

25.2

Notes
[193] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.083 ^[194]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.6

upper limit

15.8

Notes
[194] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[195]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.4

upper limit

23.1

Notes
[195] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[196]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.6

Confidence interval

level

95%

sides

2-sided

lower limit

4.4

upper limit

16.7

Notes
[196] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.22 ^[197]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

12.6

Notes
[197] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.25 ^[198]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.3

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

12.1

Notes
[198] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.35 ^[199]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

8.9

Notes
[199] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.2 ^[200]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

12.1

Notes
[200] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.36 ^[201]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

10.6

Notes
[201] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.043 ^[202]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

12.8

Notes
[202] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[203]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

17.2

Notes
[203] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

MTX Monotherapy v Filgotinib 200 mg Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.085 ^[204]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

14.4

Notes
[204] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[205]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.9

Confidence interval

level

95%

sides

2-sided

lower limit

3.2

upper limit

16.6

Notes
[205] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[206]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.5

Confidence interval

level

95%

sides

2-sided

lower limit

2.3

upper limit

18.7

Notes
[206] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.014 ^[207]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.4

upper limit

17.8

Notes
[207] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52

End point description

The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	5.7 ( 0.99 )	5.7 ( 1.04 )	5.8 ( 0.94 )	5.7 ( 1.00 )
Change at Week 2 (N=399,199,200,396)	-1.3 ( 1.06 )	-1.1 ( 0.92 )	-1.4 ( 1.12 )	-0.6 ( 0.87 )
Change at Week 4 (N=403,199,202,401)	-1.9 ( 1.26 )	-1.6 ( 1.14 )	-1.8 ( 1.20 )	-1.0 ( 1.04 )
Change at Week 12 (N=386,195,189,380)	-2.7 ( 1.31 )	-2.5 ( 1.28 )	-2.6 ( 1.26 )	-1.9 ( 1.21 )
Change at Week 24 (N=374,190,183,368)	-3.2 ( 1.31 )	-2.9 ( 1.30 )	-3.0 ( 1.16 )	-2.5 ( 1.29 )
Change at Week 36 (N=347,177,177,321)	-3.3 ( 1.28 )	-3.0 ( 1.26 )	-3.2 ( 1.12 )	-2.9 ( 1.22 )
Change at Week 52 (N=332,170,169,307)	-3.4 ( 1.23 )	-3.1 ( 1.24 )	-3.3 ( 1.11 )	-2.8 ( 1.29 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[208]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.07

Notes
[208] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 100 mg + MTX

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[209]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[209] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[210]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[210] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[211]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[211] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[212]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Variability estimate

Standard error of the mean

Dispersion value

0.09

Notes
[212] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[213]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard error of the mean

Dispersion value

0.09

Notes
[213] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[214]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[214] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[215]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[215] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[216]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[216] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[217]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[217] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[218]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[218] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[219]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[219] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[220]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[220] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.033 ^[221]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[221] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[222]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[222] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[223]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.5

Variability estimate

Standard error of the mean

Dispersion value

0.08

Notes
[223] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[224]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

-0.2

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[224] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[225]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.1

Notes
[225] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52

Top of page

End point title

Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52

End point description

The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 4	30.8 (26.2 to 35.3)	23.7 (17.6 to 29.7)	31.9 (25.4 to 38.4)	12.0 (8.8 to 15.3)
Week 12	55.8 (50.9 to 60.7)	50.2 (43.2 to 57.3)	48.1 (41.1 to 55.1)	28.6 (24.1 to 33.1)
Week 24	68.8 (64.2 to 73.3)	62.8 (56.0 to 69.6)	60.0 (53.1 to 66.9)	46.2 (41.2 to 51.1)
Week 52	69.0 (64.4 to 73.6)	59.9 (53.0 to 66.8)	65.7 (59.1 to 72.4)	47.6 (42.7 to 52.5)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[226]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.8

Confidence interval

level

95%

sides

2-sided

lower limit

13.1

upper limit

24.4

Notes
[226] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[227]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.7

Confidence interval

level

95%

sides

2-sided

lower limit

4.7

upper limit

18.6

Notes
[227] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[228]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

19.9

Confidence interval

level

95%

sides

2-sided

lower limit

12.5

upper limit

27.3

Notes
[228] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[229]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

27.2

Confidence interval

level

95%

sides

2-sided

lower limit

20.5

upper limit

33.9

Notes
[229] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[230]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

21.6

Confidence interval

level

95%

sides

2-sided

lower limit

13.2

upper limit

30.1

Notes
[230] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[231]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

19.5

Confidence interval

level

95%

sides

2-sided

lower limit

11.1

upper limit

27.9

Notes
[231] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[232]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

22.6

Confidence interval

level

95%

sides

2-sided

lower limit

15.8

upper limit

29.4

Notes
[232] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[233]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

16.6

Confidence interval

level

95%

sides

2-sided

lower limit

8.1

upper limit

25.2

Notes
[233] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[234]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

13.8

Confidence interval

level

95%

sides

2-sided

lower limit

5.3

upper limit

22.4

Notes
[234] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[235]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

21.4

Confidence interval

level

95%

sides

2-sided

lower limit

14.6

upper limit

28.2

Notes
[235] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[236]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.3

Confidence interval

level

95%

sides

2-sided

lower limit

3.7

upper limit

20.9

Notes
[236] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

MTX Monotherapy v Filgotinib 200 mg Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[237]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.1

Confidence interval

level

95%

sides

2-sided

lower limit

9.7

upper limit

26.5

Notes
[237] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52

Top of page

End point title

Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52

End point description

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week 2	7.2 (4.6 to 9.8)	4.3 (1.3 to 7.4)	10.0 (5.7 to 14.3)	1.0 (0.0 to 2.0)
Week 4	16.6 (12.9 to 20.3)	15.0 (9.9 to 20.1)	19.5 (13.9 to 25.1)	4.8 (2.6 to 7.0)
Week 12	39.7 (34.8 to 44.5)	31.9 (25.3 to 38.5)	29.5 (23.1 to 35.9)	17.1 (13.3 to 20.8)
Week 36	52.6 (47.7 to 57.6)	42.0 (35.1 to 49.0)	43.3 (36.4 to 50.3)	34.4 (29.7 to 39.1)
Week 52	53.4 (48.5 to 58.3)	43.0 (36.0 to 50.0)	46.2 (39.2 to 53.2)	31.5 (26.9 to 36.1)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[238]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.3

Confidence interval

level

95%

sides

2-sided

lower limit

3.4

upper limit

9.1

Notes
[238] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[239]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

6.7

Notes
[239] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 2

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[240]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

13.6

Notes
[240] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

MTX Monotherapy v Filgotinib 200 mg + MTX

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[241]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.8

Confidence interval

level

95%

sides

2-sided

lower limit

7.4

upper limit

16.1

Notes
[241] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[242]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.2

Confidence interval

level

95%

sides

2-sided

lower limit

4.5

upper limit

15.8

Notes
[242] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[243]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.7

Confidence interval

level

95%

sides

2-sided

lower limit

8.6

upper limit

20.8

Notes
[243] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[244]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

22.6

Confidence interval

level

95%

sides

2-sided

lower limit

16.4

upper limit

28.8

Notes
[244] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[245]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.8

Confidence interval

level

95%

sides

2-sided

lower limit

7.1

upper limit

22.5

Notes
[245] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[246]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.5

Confidence interval

level

95%

sides

2-sided

lower limit

4.9

upper limit

Notes
[246] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[247]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.3

Confidence interval

level

95%

sides

2-sided

lower limit

11.4

upper limit

25.1

Notes
[247] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.056 ^[248]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

16.1

Notes
[248] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 36

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.023 ^[249]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

17.4

Notes
[249] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[250]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

21.9

Confidence interval

level

95%

sides

2-sided

lower limit

15.1

upper limit

28.7

Notes
[250] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[251]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

11.5

Confidence interval

level

95%

sides

2-sided

lower limit

3.1

upper limit

Notes
[251] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[252]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.3

upper limit

23.1

Notes
[252] - P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.

Secondary: ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52

End point description

ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject`s pain assessment, HAQ-DI and CRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percent improvement
arithmetic mean (standard deviation)
Week 2 (N=386,191,197,387)	20.8 ( 21.42 )	17.8 ( 20.07 )	20.9 ( 23.19 )	8.9 ( 14.95 )
Week 4 (N=389,192,193,395)	34.1 ( 27.78 )	27.6 ( 24.81 )	29.4 ( 27.86 )	17.2 ( 21.43 )
Week 12 (N=377,188,185,375)	52.6 ( 29.91 )	46.1 ( 31.46 )	48.6 ( 30.50 )	34.3 ( 28.07 )
Week 24 (N=365,181,180,359)	62.8 ( 28.40 )	58.1 ( 30.19 )	59.7 ( 29.35 )	49.0 ( 29.46 )
Week 36 (N=341,170,173,315)	65.8 ( 28.50 )	58.7 ( 30.99 )	62.1 ( 28.12 )	57.3 ( 29.16 )
Week 52 (N=327,163,166,304)	69.6 ( 27.38 )	63.6 ( 29.19 )	67.4 ( 26.60 )	57.1 ( 29.59 )

No statistical analyses for this end point

Secondary: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52

End point description

Good Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit ≤3.2 and improvement from baseline >0.6 and ≤1.2; DAS28(CRP) at visit >3.2 and ≤5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2. No Response: DAS28(CRP) at visit ≤5.1 and improvement from baseline ≤0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline ≤1.2. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: participants
Week 2: Good Response (N=399,199,200,396)	66	21	35	20
Week 2: Moderate Response (N=399,199,200,396)	199	92	88	118
Week 2: No Response (N=399,199,200,396)	134	86	77	258
Week 4: Good Response (N=403,199,202,401)	120	45	63	45
Week 4: Moderate Response (N=403,199,202,401)	206	104	97	161
Week 4: No Response (N=403,199,202,401)	77	50	42	195
Week 12: Good Response (N=386,195,189,380)	230	100	98	116
Week 12: Moderate Response (N=386,195,189,380)	130	79	77	190
Week 12: No Response (N=386,195,189,380)	26	16	14	74
Week 24: Good Response (N=374,190,183,368)	283	127	126	186
Week 24: Moderate Response (N=374,190,183,368)	82	55	52	153
Week 24: No Response (N=374,190,183,368)	9	8	5	29
Week 36: Good Response (N=347,177,177,321)	276	118	124	208
Week 36: Moderate Response (N=347,177,177,321)	64	54	51	106
Week 36: No Response (N=347,177,177,321)	7	5	2	7
Week 52: Good Response (N=332,170,169,307)	286	123	136	194
Week 52: Moderate Response (N=332,170,169,307)	43	43	30	102
Week 52: No Response (N=332,170,169,307)	3	4	3	11

No statistical analyses for this end point

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52

End point description

CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	39.5 ( 12.77 )	39.2 ( 12.69 )	40.0 ( 12.63 )	40.2 ( 12.50 )
Change at Week 2 (N=396,199,201,401)	-13.6 ( 12.05 )	-12.0 ( 10.54 )	-13.9 ( 12.53 )	-8.5 ( 11.33 )
Change at Week 4 (N=401,200,198,402)	-19.9 ( 13.64 )	-17.8 ( 12.06 )	-18.4 ( 12.96 )	-13.3 ( 12.61 )
Change at Week 12 (N=388,195,191,384)	-27.8 ( 13.60 )	-26.1 ( 13.00 )	-27.5 ( 13.55 )	-22.7 ( 13.38 )
Change at Week 24 (N=372,187,184,364)	-31.3 ( 13.19 )	-30.0 ( 13.32 )	-31.3 ( 12.57 )	-28.2 ( 13.43 )
Change at Week 36 (N=347,177,178,324)	-32.2 ( 13.37 )	-30.8 ( 12.84 )	-32.7 ( 12.16 )	-31.3 ( 12.66 )
Change at Week 52 (N=332,169,171,307)	-33.8 ( 13.00 )	-31.9 ( 12.22 )	-33.6 ( 12.28 )	-31.2 ( 13.12 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[253]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

-4.1

Variability estimate

Standard error of the mean

Dispersion value

0.82

Notes
[253] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[254]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-6.4

upper limit

-2.4

Variability estimate

Standard error of the mean

Dispersion value

1.01

Notes
[254] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[255]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-7.7

upper limit

-3.7

Variability estimate

Standard error of the mean

Dispersion value

1.01

Notes
[255] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[256]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7.3

Confidence interval

level

95%

sides

2-sided

lower limit

-8.9

upper limit

-5.6

Variability estimate

Standard error of the mean

Dispersion value

0.83

Notes
[256] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[257]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.3

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

-3.3

Variability estimate

Standard error of the mean

Dispersion value

1.02

Notes
[257] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[258]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.7

Confidence interval

level

95%

sides

2-sided

lower limit

-7.8

upper limit

-3.7

Variability estimate

Standard error of the mean

Dispersion value

1.02

Notes
[258] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[259]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.8

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

-4.4

Variability estimate

Standard error of the mean

Dispersion value

0.72

Notes
[259] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[260]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-6.1

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

0.88

Notes
[260] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[261]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.1

Confidence interval

level

95%

sides

2-sided

lower limit

-6.8

upper limit

-3.4

Variability estimate

Standard error of the mean

Dispersion value

0.88

Notes
[261] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[262]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.1

Confidence interval

level

95%

sides

2-sided

lower limit

-5.3

upper limit

-2.9

Variability estimate

Standard error of the mean

Dispersion value

0.61

Notes
[262] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[263]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-1.3

Variability estimate

Standard error of the mean

Dispersion value

0.75

Notes
[263] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[264]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.4

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.75

Notes
[264] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[265]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.4

upper limit

-1.1

Variability estimate

Standard error of the mean

Dispersion value

0.59

Notes
[265] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.36 ^[266]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

0.8

Variability estimate

Standard error of the mean

Dispersion value

0.71

Notes
[266] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009 ^[267]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.3

upper limit

-0.5

Variability estimate

Standard error of the mean

Dispersion value

0.72

Notes
[267] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[268]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.3

Confidence interval

level

95%

sides

2-sided

lower limit

-4.5

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

0.56

Notes
[268] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.042 ^[269]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

-0.1

Variability estimate

Standard error of the mean

Dispersion value

0.69

Notes
[269] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[270]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.4

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.69

Notes
[270] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52

End point description

SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 86. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 2, 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	41.3 ( 13.41 )	41.0 ( 13.53 )	41.8 ( 13.09 )	41.9 ( 13.39 )
Change at Week 2 (N=394,197,200,392)	-14.9 ( 12.45 )	-12.9 ( 10.84 )	-15.0 ( 12.82 )	-8.6 ( 11.49 )
Change at Week 4 (N=397,199,196,399)	-21.3 ( 14.17 )	-19.0 ( 12.58 )	-19.6 ( 13.38 )	-13.7 ( 12.83 )
Change at Week 12 (N=384,194,188,378)	-29.2 ( 14.05 )	-27.1 ( 13.59 )	-28.6 ( 14.02 )	-23.5 ( 13.82 )
Change at Week 24 (N=372,187,183,362)	-32.7 ( 13.83 )	-31.1 ( 14.09 )	-32.7 ( 13.14 )	-29.0 ( 14.09 )
Change at Week 36 (N=346,176,176,318)	-33.5 ( 14.02 )	-32.1 ( 13.61 )	-33.9 ( 12.67 )	-32.3 ( 13.47 )
Change at Week 52 (N=332,169,169,307)	-35.2 ( 13.68 )	-33.0 ( 13.12 )	-35.0 ( 12.69 )	-32.0 ( 14.14 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[271]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.8

Confidence interval

level

95%

sides

2-sided

lower limit

-8.5

upper limit

-5.2

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[271] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[272]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.3

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

-3.3

Variability estimate

Standard error of the mean

Dispersion value

1.04

Notes
[272] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[273]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.7

Confidence interval

level

95%

sides

2-sided

lower limit

-8.8

upper limit

-4.7

Variability estimate

Standard error of the mean

Dispersion value

1.03

Notes
[273] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[274]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.3

Confidence interval

level

95%

sides

2-sided

lower limit

-9.9

upper limit

-6.6

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[274] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[275]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.2

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

-4.1

Variability estimate

Standard error of the mean

Dispersion value

1.04

Notes
[275] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[276]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.5

Confidence interval

level

95%

sides

2-sided

lower limit

-8.5

upper limit

-4.5

Variability estimate

Standard error of the mean

Dispersion value

1.04

Notes
[276] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[277]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.5

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

-5.1

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[277] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[278]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.8

Confidence interval

level

95%

sides

2-sided

lower limit

-6.5

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[278] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[279]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.6

Confidence interval

level

95%

sides

2-sided

lower limit

-7.4

upper limit

-3.8

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[279] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[280]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.6

Confidence interval

level

95%

sides

2-sided

lower limit

-5.9

upper limit

-3.4

Variability estimate

Standard error of the mean

Dispersion value

0.64

Notes
[280] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[281]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.1

Confidence interval

level

95%

sides

2-sided

lower limit

-4.6

upper limit

-1.6

Variability estimate

Standard error of the mean

Dispersion value

0.78

Notes
[281] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[282]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

-1.9

Variability estimate

Standard error of the mean

Dispersion value

0.79

Notes
[282] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[283]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.6

Confidence interval

level

95%

sides

2-sided

lower limit

-3.8

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.61

Notes
[283] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

MTX Monotherapy v Filgotinib 100 mg + MTX

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.23 ^[284]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

0.6

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[284] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005 ^[285]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.75

Notes
[285] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[286]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3.8

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2.6

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[286] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.021 ^[287]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.73

Notes
[287] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[288]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2.8

Confidence interval

level

95%

sides

2-sided

lower limit

-4.3

upper limit

-1.4

Variability estimate

Standard error of the mean

Dispersion value

0.73

Notes
[288] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52

Top of page

End point title

Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52

End point description

Participant`s radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS ≤ 0.5, Change in mTSS ≤ 0 and Change in mTSS ≤ smallest detectable change (SDC). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 24, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of participants
number (confidence interval 95%)
Week(Wk)24:Change in mTSS ≤ 0.5(N=355,184,173,356)	89.6 (86.3 to 92.9)	87.0 (81.8 to 92.1)	89.6 (84.8 to 94.4)	82.0 (77.9 to 86.2)
Wk 24: Change in mTSS ≤ 0 (N=355,184,173,356)	80.6 (76.3 to 84.8)	76.6 (70.2 to 83.0)	82.7 (76.7 to 88.6)	72.5 (67.7 to 77.3)
Wk 24:Change in mTSS≤SDC(1.53) (N=355,184,173,356	95.2 (92.8 to 97.6)	93.5 (89.6 to 97.3)	96.0 (92.7 to 99.2)	91.6 (88.5 to 94.6)
Wk 52: Change in mTSS ≤ 0.5 (N=345,176,166,330)	88.1 (84.6 to 91.7)	85.8 (80.4 to 91.2)	84.3 (78.5 to 90.2)	77.9 (73.2 to 82.5)
Wk 52: Change in mTSS ≤ 0 (N=345,176,166,330)	80.6 (76.3 to 84.9)	76.1 (69.6 to 82.7)	77.1 (70.4 to 83.8)	70.6 (65.5 to 75.7)
Wk 52:Change in mTSS≤SDC(1.77) (N=345,176,166,330)	94.2 (91.6 to 96.8)	94.9 (91.3 to 98.4)	89.2 (84.1 to 94.2)	86.7 (82.8 to 90.5)

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[289]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.6

Confidence interval

level

95%

sides

2-sided

lower limit

2.2

upper limit

12.9

Notes
[289] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.16 ^[290]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

11.6

Notes
[290] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.029 ^[291]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.6

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

14.1

Notes
[291] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[292]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

8.1

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

14.6

Notes
[292] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.33 ^[293]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

12.2

Notes
[293] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= 0

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013 ^[294]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.5

upper limit

17.9

Notes
[294] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= SDC (1.53)

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.074 ^[295]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

3.6

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

7.6

Notes
[295] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= SDC (1.53)

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.49 ^[296]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

6.9

Notes
[296] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 24 for Change in mTSS <= SDC (1.53)

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.075 ^[297]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

4.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

8.9

Notes
[297] - P-value was calculated from the logistic regression with treatment groups, and stratification factors in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[298]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

10.2

Confidence interval

level

95%

sides

2-sided

lower limit

4.3

upper limit

16.2

Notes
[298] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045 ^[299]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.9

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

15.2

Notes
[299] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0.5

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1 ^[300]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.5

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

Notes
[300] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[301]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

3.2

upper limit

16.7

Notes
[301] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.25 ^[302]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

5.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

Notes
[302] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= 0

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.14 ^[303]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

6.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

Notes
[303] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= SDC (1.77)

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[304]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.5

Confidence interval

level

95%

sides

2-sided

lower limit

2.8

upper limit

12.3

Notes
[304] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= SDC (1.77)

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[305]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

8.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.9

upper limit

13.6

Notes
[305] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Week 52 for Change in mTSS <= SDC (1.77)

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.47 ^[306]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

-3.9

upper limit

8.9

Notes
[306] - P-value was calculated from the logistic regression with treatment groups, stratification factors and campaign groups in the model.

Secondary: 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, 24, 36, and 52

End point description

The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=408,203,205,411)	40.6 ( 8.04 )	39.2 ( 8.86 )	39.6 ( 8.46 )	37.0 ( 8.13 )
Week 12 (N=394,198,195,389)	45.0 ( 8.42 )	42.9 ( 9.71 )	42.7 ( 9.90 )	40.9 ( 8.10 )
Week 24 (N=375,190,187,371)	46.3 ( 8.16 )	44.8 ( 9.39 )	44.1 ( 9.42 )	43.0 ( 8.36 )
Week 36 (N=348,178,179,327)	46.6 ( 8.17 )	45.2 ( 9.42 )	45.0 ( 8.89 )	44.4 ( 8.39 )
Week 52 (N=333,169,172,307)	47.4 ( 8.35 )	45.6 ( 9.02 )	45.9 ( 9.40 )	44.5 ( 8.32 )

No statistical analyses for this end point

Secondary: Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52

End point description

The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=414,207,208,416)	33.9 ( 7.48 )	33.7 ( 8.00 )	33.6 ( 7.70 )	33.3 ( 7.28 )
Change at Week 4 (N=406,203,203,411)	6.8 ( 6.86 )	5.3 ( 6.90 )	5.9 ( 7.53 )	3.8 ( 6.38 )
Change at Week 12 (N=392,198,193,389)	11.2 ( 8.66 )	9.1 ( 8.82 )	8.9 ( 9.17 )	7.6 ( 7.64 )
Change at Week 24 (N=373,190,185,371)	12.3 ( 8.89 )	11.1 ( 9.00 )	10.4 ( 9.09 )	9.7 ( 8.62 )
Change at Week 36 (N=346,178,177,327)	12.4 ( 9.30 )	11.7 ( 8.52 )	11.2 ( 8.54 )	11.3 ( 9.04 )
Change at Week 52 (N=331,169,170,307)	13.4 ( 9.62 )	12.0 ( 8.47 )	11.9 ( 9.22 )	11.2 ( 9.49 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[307]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

4.1

Variability estimate

Standard error of the mean

Dispersion value

0.45

Notes
[307] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[308]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.7

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.55

Notes
[308] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[309]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

3.4

Variability estimate

Standard error of the mean

Dispersion value

0.55

Notes
[309] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[310]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.7

Confidence interval

level

95%

sides

2-sided

lower limit

2.7

upper limit

4.8

Variability estimate

Standard error of the mean

Dispersion value

0.54

Notes
[310] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[311]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.5

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.66

Notes
[311] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.023 ^[312]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.66

Notes
[312] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[313]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.8

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.56

Notes
[313] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[314]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.68

Notes
[314] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.23 ^[315]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.8

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

2.2

Variability estimate

Standard error of the mean

Dispersion value

0.69

Notes
[315] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[316]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.8

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.59

Notes
[316] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.38 ^[317]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.71

Notes
[317] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.59 ^[318]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

1.8

Variability estimate

Standard error of the mean

Dispersion value

0.72

Notes
[318] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[319]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.8

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.62

Notes
[319] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11 ^[320]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

0.76

Notes
[320] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.071 ^[321]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.76

Notes
[321] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52

End point description

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=408,203,205,411)	48.7 ( 9.73 )	46.9 ( 10.42 )	47.5 ( 10.46 )	45.5 ( 11.38 )
Week 12 (N=394,198,195,389)	49.9 ( 9.49 )	49.2 ( 9.99 )	48.8 ( 10.85 )	48.1 ( 10.26 )
Week 24 (N=375,190,187,371)	50.1 ( 9.61 )	50.1 ( 10.34 )	49.2 ( 10.11 )	49.4 ( 10.25 )
Week 36 (N=348,178,179,327)	51.1 ( 9.38 )	50.6 ( 10.26 )	49.1 ( 9.61 )	49.9 ( 10.20 )
Week 52 (N=333,169,172,307)	50.9 ( 9.32 )	50.0 ( 10.08 )	49.7 ( 10.00 )	50.2 ( 9.64 )

No statistical analyses for this end point

Secondary: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52

End point description

The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=414,207,208,416)	44.6 ( 10.60 )	43.2 ( 11.47 )	43.1 ( 11.27 )	43.5 ( 11.50 )
Change at Week 4 (N=406,203,203,411)	4.1 ( 9.32 )	3.6 ( 8.93 )	4.5 ( 9.59 )	1.9 ( 9.22 )
Change at Week 12 (N=392,198,193,389)	5.3 ( 10.00 )	5.7 ( 10.04 )	5.5 ( 10.87 )	4.5 ( 10.26 )
Change at Week 24 (N=373,190,185,371)	5.4 ( 10.45 )	6.6 ( 10.89 )	5.8 ( 11.26 )	6.0 ( 10.95 )
Change at Week 36 (N=346,178,177,327)	6.5 ( 10.68 )	7.3 ( 11.17 )	5.4 ( 11.66 )	6.2 ( 10.96 )
Change at Week 52 (N=331,169,170,307)	6.2 ( 10.74 )	6.8 ( 11.47 )	6.1 ( 11.26 )	6.5 ( 11.11 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[322]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

3.8

Variability estimate

Standard error of the mean

Dispersion value

0.57

Notes
[322] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032 ^[323]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[323] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[324]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

3.8

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[324] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.023 ^[325]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

2.6

Variability estimate

Standard error of the mean

Dispersion value

0.6

Notes
[325] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.065 ^[326]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[326] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.15 ^[327]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

0.74

Notes
[327] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.73 ^[328]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

1.5

Variability estimate

Standard error of the mean

Dispersion value

0.64

Notes
[328] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.37 ^[329]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

2.2

Variability estimate

Standard error of the mean

Dispersion value

0.78

Notes
[329] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.83 ^[330]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

1.4

Variability estimate

Standard error of the mean

Dispersion value

0.78

Notes
[330] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073 ^[331]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

2.5

Variability estimate

Standard error of the mean

Dispersion value

0.66

Notes
[331] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.09 ^[332]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[332] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.68 ^[333]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

1.2

Variability estimate

Standard error of the mean

Dispersion value

0.81

Notes
[333] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3 ^[334]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.6

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.67

Notes
[334] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.69 ^[335]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

1.9

Variability estimate

Standard error of the mean

Dispersion value

0.82

Notes
[335] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.95 ^[336]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.7

upper limit

1.5

Variability estimate

Standard error of the mean

Dispersion value

0.82

Notes
[336] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, 24, 36, and 52

End point description

FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scale for a total possible score of 52. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=404,201,200,408)	35.2 ( 9.82 )	34.1 ( 10.75 )	34.2 ( 10.52 )	31.4 ( 10.87 )
Week 12 (N=386,195,190,386)	38.1 ( 10.21 )	36.6 ( 11.26 )	36.9 ( 11.16 )	35.3 ( 10.23 )
Week 24 (N=368,189,183,366)	39.1 ( 10.13 )	38.7 ( 10.11 )	37.9 ( 10.76 )	37.3 ( 10.62 )
Week 36 (N=345,177,177,324)	39.8 ( 9.58 )	38.9 ( 10.19 )	38.8 ( 10.17 )	38.1 ( 9.86 )
Week 52 (N=322,166,168,300)	40.2 ( 9.36 )	38.7 ( 9.88 )	39.7 ( 10.96 )	38.4 ( 9.91 )

No statistical analyses for this end point

Secondary: Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52

End point description

FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 52. Positive change in value indicates improvement (no or less severity of fatigue). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=411,207,206,415)	28.3 ( 10.93 )	27.3 ( 11.92 )	27.3 ( 10.90 )	27.1 ( 10.72 )
Change at Week 4 (N=403,201,198,408)	7.0 ( 9.46 )	6.7 ( 9.64 )	6.8 ( 9.94 )	4.3 ( 9.24 )
Change at Week 12 (N=383,195,188,385)	9.8 ( 11.20 )	9.2 ( 11.21 )	9.4 ( 10.57 )	8.1 ( 10.09 )
Change at Week 24 (N=365,189,181,365)	10.6 ( 11.49 )	11.4 ( 11.26 )	10.2 ( 11.37 )	10.1 ( 11.19 )
Change at Week 36 (N=343,177,174,323)	11.3 ( 11.21 )	11.9 ( 11.53 )	10.9 ( 10.81 )	11.1 ( 10.91 )
Change at Week 52 (N=320,166,166,300)	11.7 ( 11.52 )	11.9 ( 12.29 )	11.5 ( 11.17 )	11.3 ( 11.49 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[337]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.2

Confidence interval

level

95%

sides

2-sided

lower limit

2.1

upper limit

4.4

Variability estimate

Standard error of the mean

Dispersion value

0.58

Notes
[337] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[338]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

3.9

Variability estimate

Standard error of the mean

Dispersion value

0.7

Notes
[338] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[339]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

4.1

Variability estimate

Standard error of the mean

Dispersion value

0.71

Notes
[339] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[340]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

3.5

Variability estimate

Standard error of the mean

Dispersion value

0.64

Notes
[340] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.13 ^[341]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

0.78

Notes
[341] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.032 ^[342]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

3.2

Variability estimate

Standard error of the mean

Dispersion value

0.79

Notes
[342] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.061 ^[343]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

2.6

Variability estimate

Standard error of the mean

Dispersion value

0.68

Notes
[343] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11 ^[344]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.3

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.82

Notes
[344] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7 ^[345]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.3

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

1.9

Variability estimate

Standard error of the mean

Dispersion value

0.83

Notes
[345] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.028 ^[346]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.5

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

2.8

Variability estimate

Standard error of the mean

Dispersion value

0.67

Notes
[346] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.15 ^[347]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

2.7

Variability estimate

Standard error of the mean

Dispersion value

0.81

Notes
[347] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.41 ^[348]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

2.3

Variability estimate

Standard error of the mean

Dispersion value

0.81

Notes
[348] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.017 ^[349]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

3.1

Variability estimate

Standard error of the mean

Dispersion value

0.71

Notes
[349] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.27 ^[350]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

2.6

Variability estimate

Standard error of the mean

Dispersion value

0.86

Notes
[350] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.15 ^[351]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

2.9

Variability estimate

Standard error of the mean

Dispersion value

0.87

Notes
[351] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52

End point description

The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant`s health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (Anx/Dep). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: participants
Mobility:Week(Wk)4,No Problems(N=406,202,201,410)	161	66	81	104
Mobility:Wk 4,Slight Problems(N=406,202,201,410)	149	68	56	135
Mobility:Wk 4,Moderate Problems(N=406,202,201,410)	82	50	38	116
Mobility:Wk 4,Severe Problems(N=406,202,201,410)	13	17	20	54
Mobility:Wk 4,Extreme Problems(N=406,202,201,410)	1	1	6	1
Mobility:Wk 12,No Problems(N=390,196,192,388)	198	87	86	138
Mobility:Wk 12,Slight Problems(N=390,196,192,388)	135	56	60	135
Mobility:Wk 12,ModerateProblems(N=390,196,192,388)	41	36	27	91
Mobility:Wk 12,Severe Problems(N=390,196,192,388)	12	17	14	20
Mobility:Wk 12,Extreme Problems(N=390,196,192,388)	4	0	5	4
Mobility:Wk 24,No Problems(N=377,192,184,370)	208	92	95	152
Mobility:Wk 24,Slight Problems(N=377,192,184,370)	116	55	50	135
Mobility:Wk 24,ModerateProblems(N=377,192,184,370)	46	36	24	63
Mobility:Wk 24,Severe Problems(N=377,192,184,370)	5	9	13	16
Mobility:Wk 24,Extreme Problems(N=377,192,184,370)	2	0	2	4
Mobility:Wk 36,No Problems(N=365,188,180,356)	216	93	98	152
Mobility:Wk 36,Slight Problems(N=365,188,180,356)	96	60	46	135
Mobility:Wk 36,ModerateProblems(N=365,188,180,356)	48	30	27	51
Mobility:Wk 36,Severe Problems(N=365,188,180,356)	5	5	8	16
Mobility:Wk 36,Extreme Problems(N=365,188,180,356)	0	0	1	2
Mobility:Wk 52,No Problems(N=347,176,174,334)	217	91	93	156
Mobility:Wk 52,Slight Problems(N=347,176,174,334)	92	50	47	108
Mobility:Wk 52,ModerateProblems(N=347,176,174,334)	28	29	21	54
Mobility:Wk 52,Severe Problems(N=347,176,174,334)	9	6	10	15
Mobility:Wk 52,Extreme Problems(N=347,176,174,334)	1	0	3	1
Selfcare:Wk 4,No Problems(N=406,202,201,410)	214	99	102	143
Selfcare:Wk 4,Slight Problems(N=406,202,201,410)	142	63	50	141
Selfcare:Wk 4,Moderate Problems(N=406,202,201,410)	42	28	38	96
Selfcare:Wk 4,Severe Problems(N=406,202,201,410)	7	9	10	29
Selfcare:Wk 4,Extreme Problems(N=406,202,201,410)	1	3	1	1
Selfcare:Wk 12,No Problems(N=390,196,192,388)	277	113	111	190
Selfcare:Wk 12,Slight Problems(N=390,196,192,388)	85	55	55	129
Selfcare:Wk 12,ModerateProblems(N=390,196,192,388)	19	22	21	54
Selfcare:Wk 12,Severe Problems(N=390,196,192,388)	6	5	4	13
Selfcare:Wk 12,Extreme Problems(N=390,196,192,388)	3	1	1	2
Selfcare:Wk 24,No Problems(N=377,192,184,370)	283	128	112	222
Selfcare:Wk 24,Slight Problems(N=377,192,184,370)	73	42	52	95
Selfcare:Wk 24,ModerateProblems(N=377,192,184,370)	16	20	17	46
Selfcare:Wk 24,Severe Problems(N=377,192,184,370)	1	2	3	5
Selfcare:Wk 24,Extreme Problems(N=377,192,184,370)	4	0	0	2
Selfcare:Wk 36,No Problems(N=365,188,180,356)	271	122	121	224
Selfcare:Wk 36,Slight Problems(N=365,188,180,356)	70	44	41	93
Selfcare:Wk 36,ModerateProblems(N=365,188,180,356)	20	21	16	31
Selfcare:Wk 36,Severe Problems(N=365,188,180,356)	3	1	1	5
Selfcare:Wk 36,Extreme Problems(N=365,188,180,356)	1	0	1	3
Selfcare:Wk 52,No Problems(N=347,176,174,334)	268	117	117	208
Selfcare:Wk 52,Slight Problems(N=347,176,174,334)	60	36	36	84
Selfcare:Wk 52,ModerateProblems(N=347,176,174,334)	13	21	16	35
Selfcare:Wk 52,Severe Problems(N=347,176,174,334)	5	2	4	6
Selfcare:Wk 52,Extreme Problems(N=347,176,174,334)	1	0	1	1
UsualActivities:Wk 4,No Problem(N=406,202,201,410)	118	50	54	80
UsualActivities:Wk 4,Slight (N=406,202,201,410)	180	86	81	153
UsualActivities:Wk 4,Moderate (N=406,202,201,410)	90	47	49	122
UsualActivities:Wk 4,Severe (N=406,202,201,410)	16	19	14	49
UsualActivities:Wk 4,Extreme (N=406,202,201,410)	2	0	3	6
UsualActivities:Wk12,No Problem(N=390,196,192,388)	185	78	83	101
UsualActivities:Wk12,Slight (N=390,196,192,388)	148	65	61	179
UsualActivities:Wk12,Moderate (N=390,196,192,388)	44	42	35	85
UsualActivities:Wk12,Severe (N=390,196,192,388)	11	9	11	19
UsualActivities:Wk12,Extreme (N=390,196,192,388)	2	2	2	4
UsualActivities:Wk24,No Problem(N=377,192,184,370)	188	92	83	142
UsualActivities:Wk24,Slight (N=377,192,184,370)	135	60	63	147
UsualActivities:Wk24,Moderate (N=377,192,184,370)	43	31	30	64
UsualActivities:Wk24,Severe (N=377,192,184,370)	8	9	8	13
UsualActivities:Wk24,Extreme (N=377,192,184,370)	3	0	0	4
UsualActivities:Wk36,No Problem(N=365,188,180,356)	199	86	92	158
UsualActivities:Wk36,Slight (N=365,188,180,356)	119	61	51	134
UsualActivities:Wk36,Moderate (N=365,188,180,356)	42	37	31	50
UsualActivities:Wk36,Severe (N=365,188,180,356)	5	4	3	12
UsualActivities:Wk36,Extreme (N=365,188,180,356)	0	0	3	2
UsualActivities:Wk52,No Problem(N=347,176,174,334)	203	84	92	147
UsualActivities:Wk52,Slight (N=347,176,174,334)	106	62	48	125
UsualActivities:Wk52,Moderate (N=347,176,174,334)	31	22	27	50
UsualActivities:Wk52,Severe (N=347,176,174,334)	7	7	5	10
UsualActivities:Wk52,Extreme (N=347,176,174,334)	0	1	2	2
Pain/Discomfort:Wk 4,No Problem(N=406,202,201,410)	45	23	21	18
Pain/Discomfort:Wk 4,Slight (N=406,202,201,410)	208	85	91	131
Pain/Discomfort:Wk 4,Moderate (N=406,202,201,410)	132	73	60	173
Pain/Discomfort:Wk 4,Severe (N=406,202,201,410)	21	19	26	78
Pain/Discomfort:Wk 4,Extreme (N=406,202,201,410)	0	2	3	10
Pain/Discomfort:Wk12,No Problem(N=390,196,192,388)	93	35	38	41
Pain/Discomfort:Wk12,Slight (N=390,196,192,388)	202	96	81	167
Pain/Discomfort:Wk12,Moderate (N=390,196,192,388)	83	47	53	143
Pain/Discomfort:Wk12,Severe (N=390,196,192,388)	12	15	16	35
Pain/Discomfort:Wk12,Extreme (N=390,196,192,388)	0	3	4	2
Pain/Discomfort:Wk24,No Problem(N=377,192,184,370)	110	46	40	44
Pain/Discomfort:Wk24,Slight (N=377,192,184,370)	182	91	93	206
Pain/Discomfort:Wk24,Moderate (N=377,192,184,370)	75	46	42	98
Pain/Discomfort:Wk24,Severe (N=377,192,184,370)	9	9	7	22
Pain/Discomfort:Wk24,Extreme (N=377,192,184,370)	1	0	2	0
Pain/Discomfort:Wk36,No Problem(N=365,188,180,356)	102	43	39	57
Pain/Discomfort:Wk36,Slight (N=365,188,180,356)	188	90	87	195
Pain/Discomfort:Wk36,Moderate (N=365,188,180,356)	68	41	44	85
Pain/Discomfort:Wk36,Severe (N=365,188,180,356)	6	14	7	18
Pain/Discomfort:Wk36,Extreme (N=365,188,180,356)	1	0	3	1
Pain/Discomfort:Wk52,No Problem(N=347,176,174,334)	108	46	49	63
Pain/Discomfort:Wk52,Slight (N=347,176,174,334)	169	82	88	168
Pain/Discomfort:Wk52,Moderate (N=347,176,174,334)	59	40	25	80
Pain/Discomfort:Wk52,Severe (N=347,176,174,334)	11	8	9	22
Pain/Discomfort:Wk52,Extreme (N=347,176,174,334)	0	0	3	1
Anx/Dep:Wk 4,No Problems(N=406,202,201,410)	221	101	94	159
Anx/Dep:Wk 4,Slight Problems(N=406,202,201,410)	126	58	64	148
Anx/Dep:Wk 4,Moderate Problems(N=406,202,201,410)	53	33	35	73
Anx/Dep:Wk 4,Severe Problems(N=406,202,201,410)	6	10	6	25
Anx/Dep:Wk 4,Extreme Problems(N=406,202,201,410)	0	0	2	5
Anx/Dep:Wk 12,No Problems(N=390,196,192,388)	233	104	106	198
Anx/Dep:Wk 12,Slight Problems(N=390,196,192,388)	114	62	58	125
Anx/Dep:Wk 12,Moderate Problems(N=390,196,192,388)	28	19	17	49
Anx/Dep:Wk 12,Severe Problems(N=390,196,192,388)	14	9	10	15
Anx/Dep:Wk 12,Extreme Problems(N=390,196,192,388)	1	2	1	1
Anx/Dep:Wk 24,No Problems(N=377,192,184,370)	236	117	103	219
Anx/Dep:Wk 24,Slight Problems(N=377,192,184,370)	97	47	64	93
Anx/Dep:Wk 24,Moderate Problems(N=377,192,184,370)	32	25	11	42
Anx/Dep:Wk 24,Severe Problems(N=377,192,184,370)	9	3	6	14
Anx/Dep:Wk 24,Extreme Problems(N=377,192,184,370)	3	0	0	2
Anx/Dep:Wk 36,No Problems(N=365,188,180,356)	233	119	103	194
Anx/Dep:Wk 36,Slight Problems(N=365,188,180,356)	99	50	56	116
Anx/Dep:Wk 36,Moderate Problems(N=365,188,180,356)	31	13	17	32
Anx/Dep:Wk 36,Severe Problems(N=365,188,180,356)	2	5	3	12
Anx/Dep:Wk 36,Extreme Problems(N=365,188,180,356)	0	1	1	2
Anx/Dep:Wk 52,No Problems(N=347,176,174,334)	222	113	106	182
Anx/Dep:Wk 52,Slight Problems(N=347,176,174,334)	94	40	43	100
Anx/Dep:Wk 52,Moderate Problems(N=347,176,174,334)	26	18	20	45
Anx/Dep:Wk 52,Severe Problems(N=347,176,174,334)	5	5	3	5
Anx/Dep:Wk 52,Extreme Problems(N=347,176,174,334)	0	0	2	2

No statistical analyses for this end point

Secondary: EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

End point description

EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=404,201,200,408)	65 ( 18.7 )	61 ( 21.6 )	62 ( 20.0 )	56 ( 21.2 )
Week 12 (N=386,195,190,386)	69 ( 21.3 )	67 ( 22.9 )	66 ( 22.7 )	64 ( 20.7 )
Week 24 (N=368,189,183,366)	73 ( 21.0 )	72 ( 19.6 )	68 ( 22.4 )	69 ( 21.3 )
Week 36 (N=344,177,177,324)	73 ( 22.1 )	71 ( 21.8 )	69 ( 21.1 )	68 ( 22.8 )
Week 52 (N=322,166,168,300)	75 ( 21.7 )	72 ( 22.1 )	71 ( 23.7 )	71 ( 21.2 )

No statistical analyses for this end point

Secondary: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

End point description

The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health). Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: score on a scale
arithmetic mean (standard deviation)
Baseline (N=411,207,206,415)	50 ( 22.0 )	50 ( 24.6 )	51 ( 22.5 )	50 ( 22.1 )
Change at Week 4 (N=403,201,198,408)	16 ( 25.0 )	10 ( 24.6 )	11 ( 22.4 )	7 ( 25.0 )
Change at Week 12 (N=383,195,188,385)	19 ( 29.8 )	17 ( 28.0 )	15 ( 26.1 )	14 ( 27.7 )
Change at Week 24 (N=365,189,181,365)	24 ( 28.1 )	21 ( 27.7 )	17 ( 29.0 )	19 ( 28.8 )
Change at Week 36 (N=342,177,174,323)	23 ( 29.7 )	21 ( 28.6 )	18 ( 28.8 )	19 ( 29.8 )
Change at Week 52 (N=320,166,166,300)	26 ( 31.1 )	22 ( 31.5 )	20 ( 30.1 )	22 ( 30.6 )

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[352]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.3

Notes
[352] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[353]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[353] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[354]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[354] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[355]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[355] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.089 ^[356]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[356] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.18 ^[357]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.9

Notes
[357] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[358]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.5

Notes
[358] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.049 ^[359]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[359] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.84 ^[360]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.8

Notes
[360] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[361]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.6

Notes
[361] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.078 ^[362]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[362] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.39 ^[363]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

Variability estimate

Standard error of the mean

Dispersion value

Notes
[363] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

832

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[364]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

Variability estimate

Standard error of the mean

Dispersion value

1.7

Notes
[364] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 100 mg + MTX vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 100 mg + MTX v MTX Monotherapy

Number of subjects included in analysis

623

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.45 ^[365]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[365] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Filgotinib 200 mg Monotherapy vs MTX Monotherapy

Statistical analysis description

Comparison groups

Filgotinib 200 mg Monotherapy v MTX Monotherapy

Number of subjects included in analysis

626

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.85 ^[366]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.1

Notes
[366] - MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.

Secondary: Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant`s daily activities). Outcomes are expressed as impairment percentages. Higher numbers indicate greater impairment and less productivity. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of work time missed
arithmetic mean (standard deviation)
Week 4 (N=167,77,87,150)	10.1 ( 23.95 )	15.4 ( 30.46 )	9.2 ( 21.88 )	16.0 ( 30.49 )
Week 12 (N=163,72,84,161)	6.7 ( 19.11 )	7.3 ( 18.29 )	12.6 ( 24.42 )	11.3 ( 25.59 )
Week 24 (N=164,72,86,145)	6.4 ( 19.93 )	5.7 ( 13.96 )	12.4 ( 23.14 )	5.1 ( 14.21 )
Week 36 (N=156,73,85,131)	5.5 ( 15.78 )	7.0 ( 17.90 )	11.5 ( 25.28 )	5.6 ( 16.90 )
week 52 (N=149,69,76,120)	4.6 ( 14.62 )	8.5 ( 20.70 )	9.8 ( 22.21 )	6.4 ( 19.84 )

No statistical analyses for this end point

Secondary: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

End point description

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of impairment while working
arithmetic mean (standard deviation)
Week 4 (N=160,70,84,137)	29.6 ( 24.21 )	29.4 ( 27.76 )	33.9 ( 24.10 )	45.3 ( 26.04 )
Week 12 (N=160,72,81,152)	22.6 ( 23.43 )	23.6 ( 24.85 )	26.0 ( 24.78 )	32.5 ( 24.31 )
Week 24 (N=160,72,84,144)	17.9 ( 18.95 )	18.1 ( 19.40 )	23.2 ( 24.70 )	23.3 ( 21.18 )
Week 36 (N=155,72,81,129)	15.5 ( 18.38 )	16.3 ( 20.31 )	20.9 ( 24.04 )	22.7 ( 24.10 )
Week 52 (N=148,67,74,116)	14.5 ( 18.08 )	19.6 ( 22.32 )	16.5 ( 23.08 )	18.3 ( 16.95 )

No statistical analyses for this end point

Secondary: WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

End point description

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of overall work productivity
arithmetic mean (standard deviation)
Week 4 (N=160,70,84,137)	32.8 ( 25.79 )	32.3 ( 29.18 )	37.0 ( 25.87 )	48.6 ( 27.40 )
Week 12 (N=160,72,81,152)	25.1 ( 26.42 )	26.7 ( 28.11 )	31.4 ( 28.43 )	35.5 ( 26.13 )
Week 24 (N=160,72,84,144)	20.2 ( 22.36 )	22.4 ( 22.92 )	29.3 ( 28.98 )	26.2 ( 23.45 )
Week 36 (N=155,72,81,129)	18.8 ( 22.09 )	20.9 ( 23.34 )	24.5 ( 28.11 )	25.0 ( 25.89 )
Week 52 (N=148,67,74,116)	17.2 ( 21.61 )	22.9 ( 25.21 )	21.2 ( 27.26 )	20.7 ( 18.67 )

No statistical analyses for this end point

Secondary: WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

End point description

End point type

Secondary

End point timeframe

Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of activity impairment
arithmetic mean (standard deviation)
Week 4 (N=404,201,200,408)	40.4 ( 25.52 )	46.8 ( 27.82 )	45.4 ( 25.65 )	51.6 ( 24.73 )
Week 12 (N=386,195,190,386)	30.6 ( 25.53 )	36.1 ( 26.77 )	34.7 ( 27.29 )	41.1 ( 24.75 )
Week 24 (N=368,189,183,366)	26.5 ( 23.32 )	29.5 ( 26.02 )	32.3 ( 26.92 )	32.1 ( 24.44 )
Week 36 (N=344,177,177,324)	23.5 ( 22.54 )	29.7 ( 27.03 )	29.0 ( 26.08 )	31.8 ( 25.55 )
Week 52 (N=322,166,168,300)	22.5 ( 22.80 )	28.2 ( 26.54 )	25.6 ( 25.19 )	28.8 ( 23.81 )

No statistical analyses for this end point

Secondary: Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant`s daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of work time missed
arithmetic mean (standard deviation)
Baseline (N=171,78,88,167)	12.8 ( 24.29 )	20.1 ( 32.36 )	13.5 ( 26.35 )	15.6 ( 28.79 )
Change at Week 4 (N=155,70,82,138)	-1.5 ( 25.68 )	-3.3 ( 24.44 )	-4.0 ( 21.08 )	-1.3 ( 23.73 )
Change at Week 12 (N=142,67,75,141)	-4.9 ( 25.11 )	-11.0 ( 32.65 )	-2.3 ( 23.52 )	-5.2 ( 29.01 )
Change at Week 24 (N=141,63,77,122)	-4.8 ( 28.91 )	-15.5 ( 34.51 )	-3.1 ( 28.77 )	-10.6 ( 29.08 )
Change at Week 36 (N=130,62,69,107)	-6.7 ( 28.20 )	-16.4 ( 35.63 )	-4.1 ( 26.83 )	-7.9 ( 29.99 )
Change at Week 52 (N=124,59,65,97)	-4.8 ( 23.27 )	-15.7 ( 32.72 )	-2.8 ( 29.12 )	-6.7 ( 31.63 )

No statistical analyses for this end point

Secondary: Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant`s daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of impairment while working
arithmetic mean (standard deviation)
Baseline (N=163,70,82,154)	47.3 ( 26.32 )	49.0 ( 28.45 )	52.1 ( 25.81 )	53.6 ( 27.12 )
Change at Week 4 (N=144,62,77,125)	-17.8 ( 25.34 )	-19.8 ( 27.49 )	-18.3 ( 28.58 )	-7.4 ( 20.55 )
Change at Week 12 (N=135,61,70,126)	-25.6 ( 27.09 )	-28.4 ( 29.39 )	-26.0 ( 24.70 )	-20.7 ( 27.83 )
Change at Week 24 (N=132,56,72,113)	-27.1 ( 26.77 )	-32.9 ( 28.20 )	-27.9 ( 27.06 )	-28.3 ( 29.06 )
Change at Week 36 (N=123,55,64,99)	-29.1 ( 24.99 )	-33.8 ( 27.99 )	-30.3 ( 29.38 )	-28.8 ( 31.92 )
Change at Week 52 (120,51,61,89)	-32.3 ( 26.81 )	-32.7 ( 31.75 )	-33.3 ( 29.25 )	-31.5 ( 28.23 )

No statistical analyses for this end point

Secondary: Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant`s daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of overall work productivity
arithmetic mean (standard deviation)
Baseline (N=163,70,82,154)	50.8 ( 27.28 )	51.6 ( 30.10 )	54.4 ( 25.60 )	56.1 ( 28.00 )
Change at Week 4 (N=144,62,77,125)	-17.6 ( 26.21 )	-19.0 ( 29.43 )	-17.6 ( 28.69 )	-6.4 ( 22.27 )
Change at Week 12 (N=135,61,70,126)	-26.3 ( 28.85 )	-27.5 ( 30.53 )	-23.5 ( 26.01 )	-20.1 ( 28.63 )
Change at Week 24 (N=132,56,72,113)	-28.5 ( 27.71 )	-31.3 ( 30.04 )	-24.7 ( 29.61 )	-27.9 ( 29.31 )
Change at Week 36 (N=123,55,64,99)	-29.3 ( 26.76 )	-33.1 ( 31.56 )	-29.1 ( 31.79 )	-29.2 ( 32.72 )
Change at Week 52 (N=120,51,61,89)	-33.0 ( 28.74 )	-33.5 ( 32.34 )	-30.6 ( 31.24 )	-30.8 ( 28.76 )

No statistical analyses for this end point

Secondary: Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

Top of page

End point title

Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant`s daily activities). Outcomes are expressed as impairment percentages, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analysed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, 24, 36, and 52

End point values	Filgotinib 200 mg + MTX	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	MTX Monotherapy
Number of subjects analysed	416	207	210	416
Units: percentage of activity impairment
arithmetic mean (standard deviation)
Baseline (N=411,207,206,415)	60.2 ( 23.36 )	62.8 ( 23.10 )	63.3 ( 24.37 )	64.0 ( 22.59 )
Change at Week 4 (N=403,201,198,408)	-19.9 ( 24.07 )	-15.8 ( 23.90 )	-17.8 ( 27.11 )	-12.4 ( 23.80 )
Change at Week 12 (N=383,195,188,385)	-29.4 ( 27.15 )	-26.4 ( 26.19 )	-28.7 ( 27.80 )	-22.7 ( 25.32 )
Change at Week 24 (N=365,189,181,365)	-33.1 ( 26.84 )	-33.2 ( 26.97 )	-31.2 ( 28.01 )	-31.5 ( 27.80 )
Change at Week 36 (N=342,177,174,323)	-35.6 ( 26.52 )	-33.8 ( 26.48 )	-34.1 ( 28.26 )	-32.1 ( 28.47 )
Change at Week 52 (N=320,166,166,300)	-36.7 ( 27.11 )	-35.4 ( 28.32 )	-36.7 ( 28.37 )	-34.2 ( 28.83 )

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

First dose date up to last dose date (Maximum: 56 weeks) plus 30 days

Adverse event reporting additional description

The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.0

Reporting group title

MTX Monotherapy

Reporting group description

Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.

Reporting group title

Filgotinib 100 mg + MTX

Reporting group description

Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 200 mg Monotherapy

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.

Reporting group title

Filgotinib 200 mg + MTX

Reporting group description

Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks.

Serious adverse events	MTX Monotherapy	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	Filgotinib 200 mg + MTX
Total subjects affected by serious adverse events
subjects affected / exposed	28 / 416 (6.73%)	13 / 207 (6.28%)	17 / 210 (8.10%)	26 / 416 (6.25%)
number of deaths (all causes)	0	1	0	3
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Giant cell tumour of tendon sheath
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ovarian adenoma
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small cell lung cancer
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Squamous cell carcinoma
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertension
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Rheumatoid vasculitis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Varicose vein
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
subjects affected / exposed	2 / 416 (0.48%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute respiratory failure
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchiectasis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Emphysema
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
Lung consolidation
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonitis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Investigations
White blood cell count decreased
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Accidental overdose
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Incisional hernia, obstructive
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subdural haematoma
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Congenital, familial and genetic disorders
Atrial septal defect
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 416 (0.24%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Acute myocardial infarction
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lupus myocarditis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
Myocardial infarction
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Supraventricular tachycardia
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebral amyloid angiopathy
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cerebral artery occlusion
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cervical radiculopathy
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Facial paralysis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhagic stroke
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intracranial aneurysm
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vertebral artery aneurysm
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
Blood and lymphatic system disorders
Bone marrow failure
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Leukocytosis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytosis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	2 / 416 (0.48%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Proctitis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendiceal mucocoele
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Diverticular perforation
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal fistula
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Megacolon
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Upper gastrointestinal haemorrhage
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Prurigo
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Endocrine disorders
Hyperthyroidism
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Osteoarthritis
subjects affected / exposed	1 / 416 (0.24%)	2 / 207 (0.97%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal osteoarthritis
subjects affected / exposed	0 / 416 (0.00%)	2 / 207 (0.97%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arthralgia
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc disorder
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Intervertebral disc protrusion
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Spinal stenosis
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	1 / 416 (0.24%)	1 / 207 (0.48%)	0 / 210 (0.00%)	4 / 416 (0.96%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0	2 / 4
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal hernia infection
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Arthritis infective
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Herpes zoster
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Lymphangitis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia cryptococcal
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pulmonary sepsis
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyonephrosis
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Septic shock
subjects affected / exposed	0 / 416 (0.00%)	1 / 207 (0.48%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin infection
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Tracheobronchitis
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	1 / 210 (0.48%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypertriglyceridaemia
subjects affected / exposed	1 / 416 (0.24%)	0 / 207 (0.00%)	0 / 210 (0.00%)	0 / 416 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 416 (0.00%)	0 / 207 (0.00%)	0 / 210 (0.00%)	1 / 416 (0.24%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	MTX Monotherapy	Filgotinib 100 mg + MTX	Filgotinib 200 mg Monotherapy	Filgotinib 200 mg + MTX
Total subjects affected by non serious adverse events
subjects affected / exposed	164 / 416 (39.42%)	88 / 207 (42.51%)	78 / 210 (37.14%)	179 / 416 (43.03%)
Investigations
Alanine aminotransferase increased
subjects affected / exposed	11 / 416 (2.64%)	6 / 207 (2.90%)	3 / 210 (1.43%)	23 / 416 (5.53%)
occurrences all number	12	8	3	26
Vascular disorders
Hypertension
subjects affected / exposed	14 / 416 (3.37%)	10 / 207 (4.83%)	15 / 210 (7.14%)	21 / 416 (5.05%)
occurrences all number	14	10	15	25
Nervous system disorders
Headache
subjects affected / exposed	25 / 416 (6.01%)	8 / 207 (3.86%)	8 / 210 (3.81%)	23 / 416 (5.53%)
occurrences all number	30	10	8	24
Gastrointestinal disorders
Nausea
subjects affected / exposed	50 / 416 (12.02%)	35 / 207 (16.91%)	15 / 210 (7.14%)	51 / 416 (12.26%)
occurrences all number	62	43	15	58
Diarrhoea
subjects affected / exposed	21 / 416 (5.05%)	12 / 207 (5.80%)	6 / 210 (2.86%)	17 / 416 (4.09%)
occurrences all number	23	15	8	18
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	20 / 416 (4.81%)	15 / 207 (7.25%)	4 / 210 (1.90%)	17 / 416 (4.09%)
occurrences all number	20	16	4	17
Infections and infestations
Upper respiratory tract infection
subjects affected / exposed	34 / 416 (8.17%)	9 / 207 (4.35%)	14 / 210 (6.67%)	42 / 416 (10.10%)
occurrences all number	40	11	15	48
Nasopharyngitis
subjects affected / exposed	25 / 416 (6.01%)	17 / 207 (8.21%)	17 / 210 (8.10%)	21 / 416 (5.05%)
occurrences all number	31	20	22	27
Urinary tract infection
subjects affected / exposed	11 / 416 (2.64%)	13 / 207 (6.28%)	11 / 210 (5.24%)	19 / 416 (4.57%)
occurrences all number	12	14	11	23
Bronchitis
subjects affected / exposed	15 / 416 (3.61%)	11 / 207 (5.31%)	4 / 210 (1.90%)	12 / 416 (2.88%)
occurrences all number	16	11	4	15

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

05 Jul 2016

• Added urine biomarker samples as an exploratory endpoint • Updated study procedures to collect body weight at all study visits • Updated study procedures to include Treatment Satisfaction Questionnaire for Medication (TSQM) collection every 3 months • Updated the Prior and Concomitant Medications section to clarify documentation of prior medications and restriction window on injectable corticosteroids • Added an assessment of quantitative immunoglobulin (Ig) at Day 1, Week 24, and Week 52/ET • Updated to remove peripheral blood mononuclear cell substudy • Clarified eligibility criteria as needed • Updated the definition of postmenopausal females • Clarified that the magnetic resonance imaging (MRI) substudy would be performed post randomization within 7 days of first dose, at Week 12, and at Week 24 • Clarified that radiographs performed after Day 1 could be done ± 7 days of the scheduled visit • Terminology for the open label extension study was changed to long-term extension (LTE)study • Updated the disease specific questionnaires and activity scales to accurately reflect the relevant literature

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24

Primary: Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24

Secondary: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

Secondary: Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

Secondary: Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)]< 2.6 at Week 24

Secondary: Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)]< 2.6 at Week 24

Secondary: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24

Secondary: Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24

Secondary: Change From Baseline in mTSS at Week 52

Secondary: Change From Baseline in mTSS at Week 52

Secondary: Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52

Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Subject’s Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Physician’s Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52

Secondary: ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52

Secondary: ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52

Secondary: Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52

Secondary: Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52

Secondary: 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, 24, 36, and 52

Secondary: 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52

Secondary: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52

Secondary: SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52

Secondary: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Secondary: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52

Secondary: Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52

Secondary: Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52

Secondary: EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Secondary: EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Secondary: Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52

Secondary: Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

Secondary: Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52

Secondary: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

Secondary: WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52

Secondary: WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52