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Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination with Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Summary
EudraCT number	2016-000569-21
Trial protocol	BE GB DE FR HU ES PL NL
Global end of trial date	26 Jun 2018

Results information
Results version number	v2(current)
This version publication date	08 May 2021
First version publication date	04 Jul 2019
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

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Trial information

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Sponsor protocol code

GS-US-417-0302

ISRCTN number

US NCT number

NCT02873936

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

26 Jun 2018

Is this the analysis of the primary completion data?

Yes

Primary completion date

20 Mar 2018

Global end of trial reached?

Yes

Global end of trial date

26 Jun 2018

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this study was to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.

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

All participants continued to receive a stable dose of a permitted protocol-specified conventional synthetic disease-modifying antirheumatic drug (csDMARD(s)) (methotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide). MTX was not permitted to be used in combination with leflunomide.

Evidence for comparator

Actual start date of recruitment

27 Jul 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 19

Country: Number of subjects enrolled

Spain: 16

Country: Number of subjects enrolled

United Kingdom: 10

Country: Number of subjects enrolled

Belgium: 13

Country: Number of subjects enrolled

France: 9

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

Hungary: 16

Country: Number of subjects enrolled

United States: 255

Country: Number of subjects enrolled

Japan: 40

Country: Number of subjects enrolled

Mexico: 30

Country: Number of subjects enrolled

Argentina: 12

Country: Number of subjects enrolled

Korea, Republic of: 5

Country: Number of subjects enrolled

Australia: 4

Country: Number of subjects enrolled

Israel: 3

Country: Number of subjects enrolled

Switzerland: 2

Worldwide total number of subjects

449

EEA total number of subjects

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)

336

From 65 to 84 years

113

85 years and over

Subject disposition

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Recruitment details

Participants were enrolled at study sites in Australia, Asia, Europe, North America, and South America. The first participant was screened on 27 July 2016. The last study visit occurred on 26 June 2018.

Screening details

688 participants were screened. The enrolled participants continued to receive ongoing therapy with permitted protocol specified Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) (ie, methotrexate (MTX), hydroxychloroquine, sulfasalazine, or leflunomide). MTX was not permitted to be used in combination with leflunomide.

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

Arm description

Participants were administered filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24.1 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 tablet 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

Filgotinib 100 mg

Arm description

Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 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 tablet 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

Placebo

Arm description

Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Arm type

Placebo

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 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

Number of subjects in period 1 ^[1]	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Started	147	153	148
Completed	135	130	116
Not completed	12	23	32
Withdrew Consent	4	11	20
Adverse Event	3	5	3
Non-Compliance with Study Drug	1	-	1
Investigator's Discretion	3	5	4
Protocol Violation	-	1	3
Lost to follow-up	1	1	1

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: One participant who was randomized but did not receive the study drug was not included in analysis.

Baseline characteristics

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Reporting group title

Filgotinib 200 mg

Reporting group description

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Reporting group title

Placebo

Reporting group description

Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Reporting group values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo	Total
Number of subjects	147	153	148	448
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	56 ( 12.5 )	55 ( 12.0 )	56 ( 12.1 )	-
Gender categorical
Units: Subjects
Female	120	119	121	360
Male	27	34	27	88
Race
Not Permitted = local regulators did not allow collection of race information.
Units: Subjects
American Indian or Alaska Native	7	9	10	26
Asian	15	20	15	50
Black or African American	14	12	21	47
White	110	109	97	316
Other	1	3	2	6
Not Permitted	0	0	3	3
Ethnicity
Not Permitted = local regulators did not allow collection of ethnicity information.
Units: Subjects
Hispanic or Latino	26	40	41	107
Not Hispanic or Latino	120	112	107	339
Not Permitted	1	1	0	2

End points

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Reporting group title

Filgotinib 200 mg

Reporting group description

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Reporting group title

Placebo

Reporting group description

Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Primary: Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

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End point title

Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

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), subject’s global assessment of disease activity (SGA) using visual analog scale (VAS) on a scale of 0 (no disease activity) to 100 (maximum disease activity),participant`s pain assessment using VAS on a scale of 0 (no pain) to 100 (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 scored on a scale of 0 (without difficulty) to 3 (unable to do);high-sensitivity C-reactive protein (hsCRP). Full Analysis Set included participants who were randomized and received at least 1 dose of study drug. Participants with missing outcomes were set as non-responders.

End point type

Primary

End point timeframe

Week 12

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)	66.0 (58.0 to 74.0)	57.5 (49.4 to 65.7)	31.1 (23.3 to 38.9)

Filgotinib 200 mg vs Placebo

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[1]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

34.9

Confidence interval

level

95%

sides

2-sided

lower limit

23.5

upper limit

46.3

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

Filgotinib 100 mg vs Placebo

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[2]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

26.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

37.9

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

Secondary: Percentage of Participants who Achieved Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12

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End point title

Percentage of Participants who Achieved Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12

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 hsCRP (CRP=hsCRP) 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 analyzed.

End point type

Secondary

End point timeframe

Week 12

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)	40.8 (32.5 to 49.1)	37.3 (29.3 to 45.2)	15.5 (9.4 to 21.7)

Filgotinib 200 mg vs Placebo

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[3]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

25.3

Confidence interval

level

95%

sides

2-sided

lower limit

14.7

upper limit

35.8

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

Filgotinib 100 mg vs Placebo

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[4]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

21.7

Confidence interval

level

95%

sides

2-sided

lower limit

11.4

upper limit

Notes
[4] - 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 12

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End point title

Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

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, 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Week 12

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	1.70 ( 0.656 )	1.64 ( 0.683 )	1.65 ( 0.633 )
Change from Baseline at Week 12 (N=137,140,129)	-0.55 ( 0.590 )	-0.48 ( 0.602 )	-0.23 ( 0.547 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Least squares (LS)-Mean, 95% confidence interval (CI), and P-value were provided from mixed effects model for repeated measure (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 v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[5]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.32

Confidence interval

level

95%

sides

2-sided

lower limit

-0.45

upper limit

-0.19

Variability estimate

Standard error of the mean

Dispersion value

0.066

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

Filgotinib 100 mg vs Placebo

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 v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[6]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.27

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

-0.14

Variability estimate

Standard error of the mean

Dispersion value

0.065

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

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

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End point title

Percentage of Participants who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24

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 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4	22.4 (15.4 to 29.5)	21.6 (14.7 to 28.4)	7.4 (2.9 to 12.0)
Week 12	42.9 (34.5 to 51.2)	32.0 (24.3 to 39.7)	14.9 (8.8 to 20.9)
Week 24	45.6 (37.2 to 54.0)	35.3 (27.4 to 43.2)	18.9 (12.3 to 25.6)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

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

6.4

upper limit

23.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[8]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.1

Confidence interval

level

95%

sides

2-sided

lower limit

5.7

upper limit

22.6

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

17.5

upper limit

38.5

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[10]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

17.2

Confidence interval

level

95%

sides

2-sided

lower limit

7.1

upper limit

27.2

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

26.7

Confidence interval

level

95%

sides

2-sided

lower limit

15.8

upper limit

37.6

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[12]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

16.4

Confidence interval

level

95%

sides

2-sided

lower limit

5.9

upper limit

26.9

Notes
[12] - 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 4, 12, and 24

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End point title

Percentage of Participants who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24

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 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4	6.1 (1.9 to 10.3)	8.5 (3.8 to 13.2)	2.7 (0.0 to 5.7)
Week 12	21.8 (14.8 to 28.8)	14.4 (8.5 to 20.3)	6.8 (2.4 to 11.1)
Week 24	32.0 (24.1 to 39.9)	20.3 (13.6 to 27.0)	8.1 (3.4 to 12.8)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.16 ^[13]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

8.8

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.039 ^[14]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

5.8

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

11.6

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[15]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

6.5

upper limit

23.5

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.036 ^[16]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

15.2

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[17]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

23.9

Confidence interval

level

95%

sides

2-sided

lower limit

14.5

upper limit

33.3

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[18]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.2

Confidence interval

level

95%

sides

2-sided

lower limit

3.7

upper limit

20.6

Notes
[18] - 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 4 and 24

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End point title

Percentage of Participants Who Achieved ACR20 Response at Weeks 4 and 24

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 (without difficulty) to 3 (unable to do); hsCRP. Participants with missing outcomes were set as non-responders. Participants in the Full Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4	51.7 (43.3 to 60.1)	44.4 (36.2 to 52.6)	25.7 (18.3 to 33.1)
Week 24	69.4 (61.6 to 77.2)	54.9 (46.7 to 63.1)	34.5 (26.5 to 42.5)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Placebo v Filgotinib 200 mg

Number of subjects included in analysis

295

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

14.6

upper limit

37.4

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.8

Confidence interval

level

95%

sides

2-sided

lower limit

7.5

upper limit

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[21]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

34.9

Confidence interval

level

95%

sides

2-sided

lower limit

23.6

upper limit

46.3

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[22]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

20.4

Confidence interval

level

95%

sides

2-sided

lower limit

8.8

upper limit

32.1

Notes
[22] - 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: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	153	148
Units: tender joint count
arithmetic mean (standard deviation)
Baseline	28.0 ( 16.1 )	26.0 ( 15.4 )	27.0 ( 15.5 )
Change from Baseline at Week 4 (N=145,149,135)	-13.0 ( 13.5 )	-11.0 ( 11.0 )	-8.0 ( 13.8 )
Change from Baseline at Week 12 (N=136,139,129)	-18.0 ( 14.1 )	-16.0 ( 11.8 )	-12.0 ( 13.4 )
Change from Baseline at Week 24 (N=122,112,92)	-22.0 ( 14.2 )	-19.0 ( 13.0 )	-17.0 ( 13.3 )

Filgotinib 200 mg vs Placebo

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 v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[23]

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

1.4

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.027 ^[24]

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

Filgotinib 200 mg vs Placebo

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 v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[25]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6

Confidence interval

level

95%

sides

2-sided

lower limit

-8

upper limit

-3

Variability estimate

Standard error of the mean

Dispersion value

1.3

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[26]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-7

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

1.3

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

Filgotinib 200 mg vs Placebo

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 v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[27]

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

1.5

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[28]

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
[28] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

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" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	153	148
Units: swollen joint count
arithmetic mean (standard deviation)
Baseline	18.0 ( 12.5 )	17.0 ( 12.4 )	17.0 ( 9.7 )
Change from Baseline at Week 4 (N=145,149,135)	-10.0 ( 10.6 )	-7.0 ( 9.2 )	-7.0 ( 8.8 )
Change from Baseline at Week 12 (N=136,139,129)	-12.0 ( 10.5 )	-10.0 ( 8.6 )	-8.0 ( 8.9 )
Change from Baseline at Week 24 (N=122,112,92)	-14.0 ( 10.3 )	-13.0 ( 10.0 )	-12.0 ( 8.7 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[29]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-3

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.65 ^[30]

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[31]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.9

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.008 ^[32]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

0.9

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[33]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4

Confidence interval

level

95%

sides

2-sided

lower limit

-5

upper limit

-2

Variability estimate

Standard error of the mean

Dispersion value

0.9

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.039 ^[34]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

Variability estimate

Standard error of the mean

Dispersion value

0.9

Notes
[34] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	68.0 ( 20.6 )	69.0 ( 20.2 )	70.0 ( 18.0 )
Change from Baseline at Week 4 (N=146,149,138)	-21.0 ( 23.2 )	-20.0 ( 26.1 )	-10.0 ( 22.6 )
Change from Baseline at Week 12 (N=137,140,130)	-31.0 ( 25.9 )	-27.0 ( 28.4 )	-14.0 ( 26.3 )
Change from Baseline at Week 24 (N=123,112,92)	-38.0 ( 26.8 )	-34.0 ( 28.1 )	-24.0 ( 28.0 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[35]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-17

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[36]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-11

Confidence interval

level

95%

sides

2-sided

lower limit

-16

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[37]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-18

Confidence interval

level

95%

sides

2-sided

lower limit

-24

upper limit

-12

Variability estimate

Standard error of the mean

Dispersion value

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[38]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[39]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-18

Confidence interval

level

95%

sides

2-sided

lower limit

-25

upper limit

-12

Variability estimate

Standard error of the mean

Dispersion value

3.4

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[40]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

3.4

Notes
[40] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

End point description

PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 3 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	69.0 ( 17.6 )	68.0 ( 18.7 )	66.0 ( 16.7 )
Change from Baseline at Week 4 (N=145,146,136)	-32.0 ( 25.2 )	-30.0 ( 24.3 )	-19.0 ( 22.2 )
Change from Baseline at Week 12 (N=132,138,128)	-45.0 ( 25.2 )	-41.0 ( 26.7 )	-28.0 ( 26.9 )
Change from Baseline at Week 24 (N=122,111,92)	-53.0 ( 22.7 )	-45.0 ( 23.8 )	-41.0 ( 23.5 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[41]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-17

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

2.6

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[42]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10

Confidence interval

level

95%

sides

2-sided

lower limit

-15

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

2.6

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[43]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-16

Confidence interval

level

95%

sides

2-sided

lower limit

-22

upper limit

-11

Variability estimate

Standard error of the mean

Dispersion value

2.8

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[44]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-18

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[45]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-18

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.052 ^[46]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-11

upper limit

Variability estimate

Standard error of the mean

Dispersion value

2.7

Notes
[46] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	66.0 ( 21.6 )	67.0 ( 21.7 )	68.0 ( 19.9 )
Change from Baseline at Week 4 (N=145,148,137)	-22.0 ( 24.2 )	-20.0 ( 26.3 )	-8.0 ( 22.6 )
Change from Baseline at Week 12 (N=137,140,129)	-30.0 ( 27.9 )	-27.0 ( 30.9 )	-14.0 ( 27.0 )
Change from Baseline at Week 24 (N=123,113,92)	-37.0 ( 28.1 )	-35.0 ( 29.1 )	-24.0 ( 28.3 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[47]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-16

Confidence interval

level

95%

sides

2-sided

lower limit

-21

upper limit

-10

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[48]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-14

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

-8

Variability estimate

Standard error of the mean

Dispersion value

2.7

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[49]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-17

Confidence interval

level

95%

sides

2-sided

lower limit

-23

upper limit

-11

Variability estimate

Standard error of the mean

Dispersion value

3.1

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[50]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-13

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

-7

Variability estimate

Standard error of the mean

Dispersion value

3.1

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[51]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-16

Confidence interval

level

95%

sides

2-sided

lower limit

-23

upper limit

-10

Variability estimate

Standard error of the mean

Dispersion value

3.4

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[52]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-12

Confidence interval

level

95%

sides

2-sided

lower limit

-19

upper limit

-5

Variability estimate

Standard error of the mean

Dispersion value

3.4

Notes
[52] - MMRM model included treatment, visit (as categorical), 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: HAQ-DI at Weeks 4, and 24

Top of page

End point title

Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 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 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. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	1.70 ( 0.656 )	1.64 ( 0.683 )	1.65 ( 0.633 )
Change from Baseline at Week 4 (N=145,148,137)	-0.39 ( 0.493 )	-0.32 ( 0.539 )	-0.18 ( 0.444 )
Change from Baseline at Week 24 (N=123,113,92)	-0.75 ( 0.620 )	-0.60 ( 0.660 )	-0.42 ( 0.600 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Placebo v Filgotinib 200 mg

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[53]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.33

upper limit

-0.11

Variability estimate

Standard error of the mean

Dispersion value

0.055

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[54]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-0.26

upper limit

-0.04

Variability estimate

Standard error of the mean

Dispersion value

0.055

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[55]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.36

Confidence interval

level

95%

sides

2-sided

lower limit

-0.51

upper limit

-0.21

Variability estimate

Standard error of the mean

Dispersion value

0.075

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[56]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.22

Confidence interval

level

95%

sides

2-sided

lower limit

-0.37

upper limit

-0.08

Variability estimate

Standard error of the mean

Dispersion value

0.075

Notes
[56] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

End point description

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

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: mg/L
arithmetic mean (standard deviation)
Baseline	17.21 ( 18.275 )	21.49 ( 28.206 )	16.42 ( 18.321 )
Change from Baseline at Week 4 (N=144,145,132)	-9.55 ( 18.421 )	-12.15 ( 25.502 )	1.04 ( 13.942 )
Change from Baseline at Week 12 (N=137,138,129)	-11.86 ( 19.760 )	-12.02 ( 26.226 )	0.57 ( 15.178 )
Change from Baseline at Week 24 (N=121,113,88)	-10.87 ( 19.083 )	-11.12 ( 27.766 )	-1.50 ( 15.889 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[57]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10.51

Confidence interval

level

95%

sides

2-sided

lower limit

-13.61

upper limit

-7.41

Variability estimate

Standard error of the mean

Dispersion value

1.578

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[58]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.92

Confidence interval

level

95%

sides

2-sided

lower limit

-12.02

upper limit

-5.82

Variability estimate

Standard error of the mean

Dispersion value

1.577

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[59]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10.94

Confidence interval

level

95%

sides

2-sided

lower limit

-14.19

upper limit

-7.69

Variability estimate

Standard error of the mean

Dispersion value

1.652

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[60]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.98

Confidence interval

level

95%

sides

2-sided

lower limit

-12.22

upper limit

-5.73

Variability estimate

Standard error of the mean

Dispersion value

1.651

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[61]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9.87

Confidence interval

level

95%

sides

2-sided

lower limit

-13.73

upper limit

-6

Variability estimate

Standard error of the mean

Dispersion value

1.964

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[62]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.89

Confidence interval

level

95%

sides

2-sided

lower limit

-10.8

upper limit

-2.98

Variability estimate

Standard error of the mean

Dispersion value

1.987

Notes
[62] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 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 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 0-3 [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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4 (N=144,148,144)	60.4 (52.1 to 68.8)	54.7 (46.4 to 63.1)	40.3 (31.9 to 48.6)
Week 12 (N=144,148,144)	66.7 (58.6 to 74.7)	66.2 (58.3 to 74.2)	44.4 (36.0 to 52.9)
Week 24 (N=144,148,144)	68.8 (60.8 to 76.7)	54.1 (45.7 to 62.4)	35.4 (27.3 to 43.6)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[63]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

20.1

Confidence interval

level

95%

sides

2-sided

lower limit

8.1

upper limit

32.1

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.013 ^[64]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.5

Confidence interval

level

95%

sides

2-sided

lower limit

2.4

upper limit

26.5

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[65]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

22.2

Confidence interval

level

95%

sides

2-sided

lower limit

10.3

upper limit

34.1

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[66]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

21.8

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

33.6

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[67]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

33.3

Confidence interval

level

95%

sides

2-sided

lower limit

21.8

upper limit

44.9

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[68]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.6

Confidence interval

level

95%

sides

2-sided

lower limit

6.8

upper limit

30.5

Notes
[68] - 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 4, 12, and 24

Top of page

End point title

Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	5.9 ( 1.03 )	5.9 ( 0.98 )	5.9 ( 0.86 )
Change from Baseline at Week 4 (N=144,145,129)	-1.7 ( 1.16 )	-1.5 ( 1.14 )	-0.9 ( 1.14 )
Change from Baseline at Week 12 (N=136,137,128)	-2.4 ( 1.32 )	-2.3 ( 1.38 )	-1.3 ( 1.33 )
Change from Baseline at Week 24 (N=121,111,88)	-2.9 ( 1.29 )	-2.6 ( 1.32 )	-2.1 ( 1.28 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[69]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.6

Variability estimate

Standard error of the mean

Dispersion value

0.13

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[70]

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

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.13

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[71]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1.2

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

-0.9

Variability estimate

Standard error of the mean

Dispersion value

0.15

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[72]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

-0.7

Variability estimate

Standard error of the mean

Dispersion value

0.15

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[73]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

-0.8

Variability estimate

Standard error of the mean

Dispersion value

0.17

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[74]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.4

Variability estimate

Standard error of the mean

Dispersion value

0.17

Notes
[74] - MMRM model included treatment, visit (as categorical), 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 and 24

Top of page

End point title

Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4 and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4	21.8 (14.8 to 28.8)	22.2 (15.3 to 29.1)	9.5 (4.4 to 14.5)
Week 24	48.3 (39.9 to 56.7)	37.9 (29.9 to 45.9)	20.9 (14.1 to 27.8)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[75]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.3

Confidence interval

level

95%

sides

2-sided

lower limit

3.5

upper limit

21.2

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[76]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

12.8

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

21.5

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[77]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

27.4

Confidence interval

level

95%

sides

2-sided

lower limit

16.3

upper limit

38.4

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.001 ^[78]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

6.2

upper limit

27.7

Notes
[78] - 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 4, 12, and 24

Top of page

End point title

Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, 12, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP 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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of participants
number (confidence interval 95%)
Week 4	10.2 (5.0 to 15.4)	11.8 (6.3 to 17.2)	2.7 (0.0 to 5.7)
Week 12	22.4 (15.4 to 29.5)	25.5 (18.3 to 32.7)	8.1 (3.4 to 12.8)
Week 24	30.6 (22.8 to 38.4)	26.1 (18.9 to 33.4)	12.2 (6.6 to 17.8)

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.012 ^[79]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

7.5

Confidence interval

level

95%

sides

2-sided

lower limit

1.3

upper limit

13.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 4

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[80]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

9.1

Confidence interval

level

95%

sides

2-sided

lower limit

2.7

upper limit

15.5

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[81]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

14.3

Confidence interval

level

95%

sides

2-sided

lower limit

5.6

upper limit

23.1

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 12

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[82]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

17.4

Confidence interval

level

95%

sides

2-sided

lower limit

8.5

upper limit

26.2

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[83]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

18.5

Confidence interval

level

95%

sides

2-sided

lower limit

8.6

upper limit

28.3

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Week 24

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[84]

Method

Regression, Logistic

Parameter type

Difference in Response Rates

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

4.6

upper limit

23.4

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

Secondary: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24

Top of page

End point title

American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24

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 hsCRP). 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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percent improvement
arithmetic mean (standard deviation)
Week 4 (N=139,141,125)	26.9 ( 24.58 )	25.8 ( 27.09 )	13.7 ( 19.42 )
Week 12 (N=128,135,123)	43.4 ( 29.26 )	37.1 ( 30.29 )	19.7 ( 25.44 )
Week 24 (N=117,109,86)	53.5 ( 27.52 )	45.5 ( 32.16 )	31.9 ( 29.52 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: participants
Week 4: Good Response (N=144,145,129)	32	34	13
Week 4: Moderate Response (N=144,145,129)	74	65	53
Week 4: No Response (N=144,145,129)	38	46	63
Week 12: Good Response (N=136,137,128)	58	56	23
Week 12: Moderate Response (N=136,137,128)	65	58	51
Week 12: No Response (N=136,137,128)	13	23	54
Week 24: Good Response (N=121,111,88)	70	58	31
Week 24: Moderate Response (N=121,111,88)	43	47	45
Week 24: No Response (N=121,111,88)	8	6	12

No statistical analyses for this end point

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

Top of page

End point title

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

End point description

CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (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. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	41.7 ( 14.23 )	40.4 ( 13.23 )	41.4 ( 12.00 )
Change from Baseline at Week 4 (N=145,146,135)	-19.1 ( 13.06 )	-16.8 ( 12.95 )	-12.8 ( 13.71 )
Change from Baseline at Week 12 (N=132,137,128)	-26.2 ( 15.04 )	-23.8 ( 14.33 )	-17.3 ( 15.22 )
Change from Baseline at Week 24 (N=122,110,92)	-30.9 ( 13.77 )	-27.8 ( 13.54 )	-25.4 ( 14.40 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[85]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7.1

Confidence interval

level

95%

sides

2-sided

lower limit

-10

upper limit

-4.2

Variability estimate

Standard error of the mean

Dispersion value

1.47

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[86]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5

Confidence interval

level

95%

sides

2-sided

lower limit

-7.9

upper limit

-2.2

Variability estimate

Standard error of the mean

Dispersion value

1.46

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[87]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-9.5

Confidence interval

level

95%

sides

2-sided

lower limit

-12.6

upper limit

-6.5

Variability estimate

Standard error of the mean

Dispersion value

1.56

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[88]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-7.6

Confidence interval

level

95%

sides

2-sided

lower limit

-10.6

upper limit

-4.5

Variability estimate

Standard error of the mean

Dispersion value

1.55

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[89]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.7

Confidence interval

level

95%

sides

2-sided

lower limit

-11.9

upper limit

-5.5

Variability estimate

Standard error of the mean

Dispersion value

1.64

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[90]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-4.9

Confidence interval

level

95%

sides

2-sided

lower limit

-8.2

upper limit

-1.6

Variability estimate

Standard error of the mean

Dispersion value

1.66

Notes
[90] - MMRM model included treatment, visit (as categorical), 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 4, 12, and 24

Top of page

End point title

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

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 0 to 86. A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	43.4 ( 14.64 )	42.6 ( 14.16 )	43.0 ( 12.33 )
Change from Baseline at Week 4 (N=143,143,129)	-20.1 ( 13.73 )	-18.1 ( 13.19 )	-12.9 ( 14.01 )
Change from Baseline at Week 12 (N=131,135,127)	-27.6 ( 15.54 )	-24.9 ( 15.01 )	-17.2 ( 15.52 )
Change from Baseline at Week 24 (N=120,110,88)	-32.1 ( 14.41 )	-28.8 ( 14.19 )	-24.9 ( 14.84 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[91]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.1

Confidence interval

level

95%

sides

2-sided

lower limit

-11.1

upper limit

-5.1

Variability estimate

Standard error of the mean

Dispersion value

1.52

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[92]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-5.9

Confidence interval

level

95%

sides

2-sided

lower limit

-8.9

upper limit

-2.9

Variability estimate

Standard error of the mean

Dispersion value

1.52

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[93]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10.7

Confidence interval

level

95%

sides

2-sided

lower limit

-13.8

upper limit

-7.5

Variability estimate

Standard error of the mean

Dispersion value

1.6

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[94]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-8.7

Confidence interval

level

95%

sides

2-sided

lower limit

-11.8

upper limit

-5.5

Variability estimate

Standard error of the mean

Dispersion value

1.59

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

295

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[95]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-10.1

Confidence interval

level

95%

sides

2-sided

lower limit

-13.5

upper limit

-6.8

Variability estimate

Standard error of the mean

Dispersion value

1.7

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[96]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

-6.1

Confidence interval

level

95%

sides

2-sided

lower limit

-9.4

upper limit

-2.7

Variability estimate

Standard error of the mean

Dispersion value

1.71

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

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

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=147,149,146)	35.4 ( 8.72 )	36.4 ( 9.29 )	33.7 ( 8.67 )
Week 12 (N=142,144,133)	38.3 ( 10.14 )	38.6 ( 9.39 )	35.1 ( 9.90 )
Week 24 (N=123,112,92)	40.4 ( 9.64 )	40.3 ( 10.31 )	37.7 ( 9.09 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	30.4 ( 7.75 )	31.7 ( 7.76 )	31.1 ( 8.17 )
Change from Baseline at Week 4 (N=146,149,146)	5.1 ( 6.34 )	4.5 ( 6.53 )	2.5 ( 5.91 )
Change from Baseline at Week 12 (N=141,144,133)	7.6 ( 7.68 )	6.8 ( 8.22 )	3.6 ( 8.16 )
Change from Baseline at Week 24 (N=122,112,92)	9.4 ( 8.23 )	9.0 ( 8.44 )	6.6 ( 7.95 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Placebo v Filgotinib 200 mg

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[97]

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.005 ^[98]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

0.6

upper limit

3.4

Variability estimate

Standard error of the mean

Dispersion value

0.7

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[99]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

4.3

Confidence interval

level

95%

sides

2-sided

lower limit

2.5

upper limit

6.1

Variability estimate

Standard error of the mean

Dispersion value

0.92

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[100]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.4

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

5.2

Variability estimate

Standard error of the mean

Dispersion value

0.92

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[101]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.9

Confidence interval

level

95%

sides

2-sided

lower limit

1.9

upper limit

5.9

Variability estimate

Standard error of the mean

Dispersion value

1.02

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[102]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.1

Confidence interval

level

95%

sides

2-sided

lower limit

1.1

upper limit

5.2

Variability estimate

Standard error of the mean

Dispersion value

1.03

Notes
[102] - MMRM model included treatment, visit (as categorical), 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, and 24

Top of page

End point title

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

End point description

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=147,149,146)	48.0 ( 11.48 )	47.3 ( 11.51 )	45.5 ( 11.11 )
Week 12 (N=142,144,133)	50.2 ( 10.58 )	48.8 ( 11.02 )	47.9 ( 11.01 )
Week 24 (N=123,112,92)	50.6 ( 10.35 )	49.5 ( 10.72 )	49.1 ( 10.56 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	44.5 ( 11.97 )	44.2 ( 11.59 )	44.3 ( 11.32 )
Change from Baseline at Week 4 (N=146,149,146)	3.5 ( 9.17 )	3.0 ( 9.03 )	1.2 ( 9.34 )
Change from Baseline at Week 12 (N=141,144,133)	5.3 ( 10.60 )	4.6 ( 9.76 )	3.7 ( 9.17 )
Change from Baseline at Week 24 (N=122,112,92)	6.5 ( 12.50 )	4.6 ( 9.22 )	4.3 ( 9.44 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[103]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.3

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

4.2

Variability estimate

Standard error of the mean

Dispersion value

0.97

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.073 ^[104]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

3.6

Variability estimate

Standard error of the mean

Dispersion value

0.97

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.045 ^[105]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

4.1

Variability estimate

Standard error of the mean

Dispersion value

1.03

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.32 ^[106]

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

1.02

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

294

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.12 ^[107]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

1.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

4.2

Variability estimate

Standard error of the mean

Dispersion value

1.19

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

301

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.96 ^[108]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

0.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

2.4

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[108] - MMRM model included treatment, visit (as categorical), 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, and 24

Top of page

End point title

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

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 0 to 52. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=145,144,144)	30.4 ( 12.48 )	30.3 ( 12.30 )	27.9 ( 11.29 )
Week 12 (N=141,143,132)	34.0 ( 12.08 )	32.1 ( 13.66 )	30.4 ( 11.79 )
Week 24 (N=123,110,90)	36.3 ( 11.58 )	34.4 ( 12.51 )	33.3 ( 11.26 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue). Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	152	147
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	24.2 ( 11.47 )	23.7 ( 12.30 )	25.4 ( 10.89 )
Change from Baseline at Week 4 (N=144,144,144)	6.2 ( 10.20 )	6.4 ( 9.87 )	2.2 ( 8.92 )
Change from Baseline at Week 12 (N=140,143,132)	9.6 ( 11.24 )	8.3 ( 10.80 )	4.5 ( 10.37 )
Change from Baseline at Week 24 (N=122,110,90)	11.6 ( 11.67 )	9.8 ( 10.39 )	7.0 ( 10.23 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[109]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.7

Confidence interval

level

95%

sides

2-sided

lower limit

1.6

upper limit

5.7

Variability estimate

Standard error of the mean

Dispersion value

1.05

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[110]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.3

Confidence interval

level

95%

sides

2-sided

lower limit

1.2

upper limit

5.4

Variability estimate

Standard error of the mean

Dispersion value

1.05

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[111]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

Confidence interval

level

95%

sides

2-sided

lower limit

2.6

upper limit

7.3

Variability estimate

Standard error of the mean

Dispersion value

1.19

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[112]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

3.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.9

upper limit

5.5

Variability estimate

Standard error of the mean

Dispersion value

1.18

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[113]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

4.6

Confidence interval

level

95%

sides

2-sided

lower limit

2.1

upper limit

7.1

Variability estimate

Standard error of the mean

Dispersion value

1.28

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11 ^[114]

Method

MMRM

Parameter type

Least Squares Mean Difference

Point estimate

2.1

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

4.7

Variability estimate

Standard error of the mean

Dispersion value

1.3

Notes
[114] - MMRM model included treatment, visit (as categorical), 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, and 24

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, and 24

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 (Usu Act), pain/discomfort (Pai/Disc), 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 labelled 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 analyzed.

End point type

Secondary

End point timeframe

Weeks (Wk) 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: participants
Mobility: Wk 4: No Problems (N=145,144,144)	34	45	32
Mobility: Wk 4: Slight Problems (N=145,144,144)	58	49	49
Mobility: Wk 4: Moderate Problems (N=145,144,144)	38	33	36
Mobility: Wk 4: Severe Problems (N=145,144,144)	15	16	25
Mobility: Wk 4: Extreme Problems (N=145,144,144)	0	1	2
Mobility: Wk 12: No Problems (N=141,143,132)	47	57	38
Mobility: Wk 12: Slight Problems (N=141,143,132)	55	48	46
Mobility: Wk 12: Moderate Problems (N=141,143,132)	25	29	29
Mobility: Wk 12: Severe Problems (N=141,143,132)	13	9	19
Mobility: Wk 12: Extreme Problems (N=141,143,132)	1	0	0
Mobility: Wk 24: No Problems (N=123,110,90)	51	38	32
Mobility: Wk 24: Slight Problems (N=123,110,90)	38	45	29
Mobility: Wk 24: Moderate Problems (N=123,110,90)	23	18	24
Mobility: Wk 24: Severe Problems (N=123,110,90)	11	8	5
Mobility: Wk 24: Extreme Problems (N=123,110,90)	0	1	0
Self-care: Wk 4: No Problems (N=145,144,144)	67	67	49
Self-care: Wk 4: Slight Problems (N=145,144,144)	45	43	52
Self-care: Wk 4: Moderate Problems (N=145,144,144)	24	27	28
Self-care: Wk 4: Severe Problems (N=145,144,144)	6	6	11
Self-care: Wk 4: Extreme Problems (N=145,144,144)	3	1	4
Self-care: Wk 12: No Problems (N=141,143,132)	79	78	56
Self-care: Wk 12: Slight Problems (N=141,143,132)	38	46	44
Self-care: Wk 12: Moderate Problems(N=141,143,132)	16	15	21
Self-care: Wk 12: Severe Problems (N=141,143,132)	6	4	11
Self-care: Wk 12: Extreme Problems (N=141,143,132)	2	0	0
Self-care: Wk 24: No Problems (N=123,110,90)	83	58	45
Self-care: Wk 24: Slight Problems (N=123,110,90)	23	31	31
Self-care: Wk 24: Moderate Problems (N=123,110,90)	13	16	10
Self-care: Wk 24: Severe Problems (N=123,110,90)	4	4	4
Self-care: Wk 24: Extreme Problems (N=123,110,90)	0	1	0
Usu Act: Wk 4: No Problems (N=145,144,144)	27	38	22
Usu Act: Wk 4: Slight Problems (N=145,144,144)	65	50	44
Usu Act: Wk 4: Moderate Problems (N=145,144,144)	26	38	49
Usu Act: Wk 4: Severe Problems (N=145,144,144)	19	12	25
Usu Act: Wk 4: Extreme Problems (N=145,144,144)	8	6	4
Usu Act: Wk 12: No Problems (N=141,143,132)	47	51	26
Usu Act: Wk 12: Slight Problems (N=141,143,132)	54	41	48
Usu Act: Wk 12: Moderate Problems (N=141,143,132)	25	37	38
Usu Act: Wk 12: Severe Problems (N=141,143,132)	15	11	20
Usu Act: Wk 12: Extreme Problems (N=141,143,132)	0	3	0
Usu Act: Wk 24: No Problems (N=123,110,90)	51	41	20
Usu Act: Wk 24: Slight Problems (N=123,110,90)	45	32	41
Usu Act: Wk 24: Moderate Problems (N=123,110,90)	18	28	24
Usu Act: Wk 24: Severe Problems (N=123,110,90)	8	7	4
Usu Act: Wk 24: Extreme Problems (N=123,110,90)	1	2	1
Pai/Disc: Wk 4: No Problems (N=145,144,144)	8	11	3
Pai/Disc: Wk 4: Slight Problems (N=145,144,144)	69	57	37
Pai/Disc: Wk 4: Moderate Problems (N=145,144,144)	45	50	62
Pai/Disc: Wk 4: Severe Problems (N=145,144,144)	19	22	36
Pai/Disc: Wk 4: Extreme Problems (N=145,144,144)	4	4	6
Pai/Disc: Wk 12: No Problems (N=141,143,132)	21	16	10
Pai/Disc: Wk 12: Slight Problems (N=141,143,132)	68	56	36
Pai/Disc: Wk 12: Moderate Problems (N=141,143,132)	34	56	57
Pai/Disc: Wk 12: Severe Problems (N=141,143,132)	17	14	28
Pai/Disc: Wk 12: Extreme Problems (N=141,143,132)	1	1	1
Pai/Disc: Wk 24: No Problems (N=123,110,90)	18	20	10
Pai/Disc: Wk 24: Slight Problems (N=123,110,90)	61	42	32
Pai/Disc: Wk 24: Moderate Problems (N=123,110,90)	31	36	33
Pai/Disc: Wk 24: Severe Problems (N=123,110,90)	12	10	14
Pai/Disc: Wk 24: Extreme Problems (N=123,110,90)	1	2	1
Anx/Dep: Wk 4: No Problems (N=145,144,144)	78	77	60
Anx/Dep: Wk 4: Slight Problems (N=145,144,144)	33	41	43
Anx/Dep: Wk 4: Moderate Problems (N=145,144,144)	25	21	34
Anx/Dep: Wk 4: Severe Problems (N=145,144,144)	8	4	5
Anx/Dep: Wk 4: Extreme Problems (N=145,144,144)	1	1	2
Anx/Dep: Wk 12: No Problems (N=141,143,132)	79	84	71
Anx/Dep: Wk 12: Slight Problems (N=141,143,132)	33	30	34
Anx/Dep: Wk 12: Moderate Problems (N=141,143,132)	23	26	23
Anx/Dep: Wk 12: Severe Problems (N=141,143,132)	5	3	3
Anx/Dep: Wk 12: Extreme Problems (N=141,143,132)	1	0	1
Anx/Dep: Wk 24: No Problems (N=123,110,90)	70	62	50
Anx/Dep: Wk 24: Slight Problems (N=123,110,90)	33	30	19
Anx/Dep: Wk 24: Moderate Problems (N=123,110,90)	16	13	15
Anx/Dep: Wk 24: Severe Problems (N=123,110,90)	4	4	6
Anx/Dep: Wk 24: Extreme Problems (N=123,110,90)	0	1	0

No statistical analyses for this end point

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

Top of page

End point title

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

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 labelled 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 analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N=145,144,144)	59.0 ( 22.1 )	60.0 ( 19.8 )	52.0 ( 24.2 )
Week 12 (N=141,143,132)	66.0 ( 23.2 )	65.0 ( 22.2 )	58.0 ( 23.0 )
Week 24 (N=123,110,90)	70.0 ( 21.8 )	69.0 ( 21.3 )	62.0 ( 23.0 )

No statistical analyses for this end point

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

Top of page

End point title

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

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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	152	147
Units: score on a scale
arithmetic mean (standard deviation)
Baseline	49.0 ( 24.7 )	46.0 ( 24.0 )	46.0 ( 22.4 )
Change from Baseline at Week 4 (N=144,144,144)	10.0 ( 27.6 )	14.0 ( 26.8 )	6.0 ( 26.0 )
Change from Baseline at Week 12 (N=140,143,132)	17.0 ( 30.9 )	19.0 ( 26.4 )	12.0 ( 26.5 )
Change from Baseline at Week 24 (N=122,110,90)	22.0 ( 30.8 )	25.0 ( 26.7 )	17.0 ( 25.4 )

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.009 ^[115]

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

2.5

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[116]

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

2.5

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.003 ^[117]

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

2.6

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[118]

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

2.6

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

Filgotinib 200 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 200 mg v Placebo

Number of subjects included in analysis

293

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[119]

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

2.9

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

Filgotinib 100 mg vs Placebo

Statistical analysis description

Comparison groups

Filgotinib 100 mg v Placebo

Number of subjects included in analysis

299

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[120]

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

2.9

Notes
[120] - MMRM model included treatment, visit (as categorical), 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, and 24

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, and 24

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of work time missed
arithmetic mean (standard deviation)
Week 4 (N=39,53,46)	8.8 ( 21.01 )	18.2 ( 30.93 )	14.3 ( 27.52 )
Week 12 (N=38,48,45)	5.6 ( 13.79 )	14.6 ( 27.13 )	12.1 ( 24.39 )
Week 24 (N=40,38,30)	7.6 ( 16.37 )	13.8 ( 26.23 )	8.5 ( 18.08 )

No statistical analyses for this end point

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

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of impairment while working
arithmetic mean (standard deviation)
Week 4 (N=38,49,43)	27.4 ( 22.50 )	37.8 ( 25.43 )	48.6 ( 29.81 )
Week 12 (N=38,46,43)	23.9 ( 20.99 )	34.8 ( 27.22 )	44.2 ( 29.21 )
Week 24 (N=40,36,30)	28.0 ( 27.57 )	25.6 ( 22.10 )	36.7 ( 26.95 )

No statistical analyses for this end point

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

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of overall work productivity
arithmetic mean (standard deviation)
Week 4 (N=38,49,43)	30.8 ( 24.36 )	43.1 ( 27.82 )	51.3 ( 30.85 )
Week 12 (N=38,46,43)	26.9 ( 24.20 )	39.5 ( 29.37 )	46.9 ( 30.63 )
Week 24 (N=40,36,30)	31.7 ( 29.94 )	31.4 ( 25.65 )	39.8 ( 29.49 )

No statistical analyses for this end point

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

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. Participants in the Full Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	147	153	148
Units: percentage of activity impairment
arithmetic mean (standard deviation)
Week 4 (N=145,144,144)	49.6 ( 26.56 )	49.9 ( 27.43 )	60.3 ( 25.49 )
Week 12 (N=141,143,132)	40.3 ( 26.75 )	45.5 ( 28.23 )	53.0 ( 27.26 )
Week 24 (N=123,110,90)	33.3 ( 24.61 )	37.5 ( 27.00 )	45.7 ( 25.57 )

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, and 24

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	35	54	48
Units: percentage of work time missed
arithmetic mean (standard deviation)
Baseline	11.3 ( 16.31 )	19.2 ( 28.57 )	10.8 ( 25.65 )
Change from Baseline at Week 4 (N=34,48,43)	-4.3 ( 20.98 )	-3.4 ( 24.57 )	4.0 ( 20.75 )
Change from Baseline at Week 12 (N=31,46,40)	-3.6 ( 17.60 )	-7.0 ( 30.93 )	3.8 ( 18.40 )
Change from Baseline at Week 24 (N=29,34,25)	-4.6 ( 22.50 )	-3.1 ( 34.28 )	3.7 ( 25.13 )

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, and 24

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	35	51	46
Units: percentage of impairment while working
arithmetic mean (standard deviation)
Baseline	46.9 ( 24.71 )	51.0 ( 27.95 )	55.7 ( 26.64 )
Change from Baseline at Week 4 (N=34,45,40)	-19.1 ( 25.63 )	-13.1 ( 25.75 )	-5.3 ( 25.52 )
Change from Baseline at Week 12 (N=31,42,38)	-20.0 ( 25.56 )	-18.8 ( 28.64 )	-10.8 ( 20.32 )
Change from Baseline at Week 24 (N=29,31,25)	-18.6 ( 22.48 )	-28.7 ( 25.26 )	-20.0 ( 31.36 )

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, and 24

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	35	51	46
Units: percentage of overall work productivity
arithmetic mean (standard deviation)
Baseline	52.0 ( 24.02 )	55.8 ( 30.53 )	56.7 ( 27.60 )
Change from Baseline at Week 4 (N=34,45,40)	-20.9 ( 28.94 )	-12.3 ( 28.05 )	-3.4 ( 25.48 )
Change from Baseline at Week 12 (N=31,42,38)	-22.8 ( 29.20 )	-19.5 ( 31.49 )	-8.3 ( 20.16 )
Change from Baseline at Week 24 (N=29,31,25)	-20.5 ( 26.20 )	-26.4 ( 29.87 )	-16.7 ( 33.28 )

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, and 24

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End point title

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

End point description

The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-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: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. 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 analyzed.

End point type

Secondary

End point timeframe

Baseline; Weeks 4, 12, and 24

End point values	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Number of subjects analysed	146	152	147
Units: percentage of activity impairment
arithmetic mean (standard deviation)
Baseline	65.6 ( 22.16 )	64.6 ( 23.07 )	65.4 ( 23.33 )
Change from Baseline at Week 4 (N=144,144,144)	-16.0 ( 24.64 )	-14.3 ( 22.89 )	-4.7 ( 25.06 )
Change from Baseline at Week 12 (N=140,143,132)	-25.0 ( 26.81 )	-19.2 ( 28.32 )	-11.3 ( 25.75 )
Change from Baseline at Week 24 (N=122,110,90)	-32.5 ( 27.37 )	-27.1 ( 27.97 )	-18.4 ( 31.23 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

First dose date up to last dose date (Maximum 29.3 weeks) plus 30 days

Adverse event reporting additional description

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

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Filgotinib 200 mg

Reporting group description

Reporting group title

Filgotinib 100 mg

Reporting group description

Participants were administered filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Reporting group title

Placebo

Reporting group description

Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + stable dose of permitted csDMARDs for median exposure of 24 weeks.

Serious adverse events	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	6 / 147 (4.08%)	8 / 153 (5.23%)	5 / 148 (3.38%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Concussion
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Laceration
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar vertebral fracture
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rib fracture
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subarachnoid haemorrhage
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial ischaemia
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Systemic inflammatory response syndrome
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Uterine haemorrhage
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary oedema
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Depression
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Bursitis
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lumbar spinal stenosis
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteitis
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rheumatoid arthritis
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Gastroenteritis
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	2 / 148 (1.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abscess oral
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gallbladder empyema
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vulval abscess
subjects affected / exposed	0 / 147 (0.00%)	1 / 153 (0.65%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 147 (0.00%)	0 / 153 (0.00%)	1 / 148 (0.68%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lactic acidosis
subjects affected / exposed	1 / 147 (0.68%)	0 / 153 (0.00%)	0 / 148 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Filgotinib 200 mg	Filgotinib 100 mg	Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	39 / 147 (26.53%)	35 / 153 (22.88%)	31 / 148 (20.95%)
Nervous system disorders
Headache
subjects affected / exposed	8 / 147 (5.44%)	9 / 153 (5.88%)	2 / 148 (1.35%)
occurrences all number	8	11	2
Gastrointestinal disorders
Nausea
subjects affected / exposed	7 / 147 (4.76%)	8 / 153 (5.23%)	5 / 148 (3.38%)
occurrences all number	9	8	5
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
subjects affected / exposed	2 / 147 (1.36%)	2 / 153 (1.31%)	8 / 148 (5.41%)
occurrences all number	2	2	11
Infections and infestations
Nasopharyngitis
subjects affected / exposed	15 / 147 (10.20%)	9 / 153 (5.88%)	7 / 148 (4.73%)
occurrences all number	15	11	7
Upper respiratory tract infection
subjects affected / exposed	8 / 147 (5.44%)	9 / 153 (5.88%)	6 / 148 (4.05%)
occurrences all number	9	9	6
Bronchitis
subjects affected / exposed	8 / 147 (5.44%)	3 / 153 (1.96%)	8 / 148 (5.41%)
occurrences all number	9	5	8

More information

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Were there any global substantial amendments to the protocol? Yes

05 Jul 2016

● Updated to reflect the removal of radiologic assessments (including removal of modified Total Sharp Score [mTSS] objectives as a measure of joint structural damage derived from x-rays) ● 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 at several study visits ● Added a carotid artery ultrasound substudy ● Added an assessment of quantitative immunoglobulin (Ig) at Day 1 and Week 24 (Early Termination) ● Added assessments of hemoglobin A1c (HbA1c), leptin, low-density lipoprotein (LDL) particle, homocysteine, and Apo A1/B for subjects participating in the carotid artery ultrasound substudy ● Removed peripheral blood mononuclear cell biomarker sampling ● Clarified criteria for interruption of study drugs ● Updated the definition of postmenopausal females

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

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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 12

Primary: Percentage of Participants who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12

Secondary: Percentage of Participants who Achieved Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12

Secondary: Percentage of Participants who Achieved Disease Activity Score 28 C-Reactive Protein (DAS28(CRP)) ≤ 3.2 at Week 12

Secondary: Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

Secondary: Change from Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Week 12

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

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

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

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

Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 4 and 24

Secondary: Percentage of Participants Who Achieved ACR20 Response at Weeks 4 and 24

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

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

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

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

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

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

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

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

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

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

Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24

Secondary: Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24

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

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

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

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

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

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

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

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

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, 12, and 24

Secondary: Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, 12, and 24

Secondary: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24

Secondary: American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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