Clinical Trial Results:
A Randomized, Doubleblind, Placebo and Activecontrolled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 weeks in Combination with Methotrexate to Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
Summary


EudraCT number 
201600056841 
Trial protocol 
SK GB BE HU CZ DE ES BG PL NL IT 
Global end of trial date 
20 Jun 2019

Results information


Results version number 
v2(current) 
This version publication date 
04 Jun 2021

First version publication date 
05 Jul 2020

Other versions 
v1 
Version creation reason 

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


Trial identification


Sponsor protocol code 
GSUS4170301


Additional study identifiers


ISRCTN number 
  
US NCT number 
NCT02889796  
WHO universal trial number (UTN) 
  
Sponsors


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


Paediatric regulatory details


Is trial part of an agreed paediatric investigation plan (PIP) 
No


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


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


Results analysis stage


Analysis stage 
Final


Date of interim/final analysis 
20 Jun 2019


Is this the analysis of the primary completion data? 
Yes


Primary completion date 
04 Jul 2018


Global end of trial reached? 
Yes


Global end of trial date 
20 Jun 2019


Was the trial ended prematurely? 
No


General information about the trial


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 
Methotrexate (MTX) was used across all the arms as background therapy.  
Evidence for comparator 
  
Actual start date of recruitment 
30 Aug 2016


Long term followup planned 
No


Independent data monitoring committee (IDMC) involvement? 
Yes


Population of trial subjects


Number of subjects enrolled per country 

Country: Number of subjects enrolled 
Slovakia: 8


Country: Number of subjects enrolled 
South Africa: 34


Country: Number of subjects enrolled 
Spain: 30


Country: Number of subjects enrolled 
Taiwan: 44


Country: Number of subjects enrolled 
Thailand: 23


Country: Number of subjects enrolled 
Ukraine: 235


Country: Number of subjects enrolled 
United Kingdom: 14


Country: Number of subjects enrolled 
United States: 200


Country: Number of subjects enrolled 
Argentina: 57


Country: Number of subjects enrolled 
Australia: 1


Country: Number of subjects enrolled 
Belgium: 10


Country: Number of subjects enrolled 
Bulgaria: 34


Country: Number of subjects enrolled 
Canada: 12


Country: Number of subjects enrolled 
Czech Republic: 34


Country: Number of subjects enrolled 
Germany: 20


Country: Number of subjects enrolled 
Hong Kong: 7


Country: Number of subjects enrolled 
Hungary: 47


Country: Number of subjects enrolled 
India: 137


Country: Number of subjects enrolled 
Ireland: 1


Country: Number of subjects enrolled 
Israel: 11


Country: Number of subjects enrolled 
Italy: 6


Country: Number of subjects enrolled 
Japan: 147


Country: Number of subjects enrolled 
Korea, Democratic People's Republic of: 33


Country: Number of subjects enrolled 
Mexico: 125


Country: Number of subjects enrolled 
Netherlands: 2


Country: Number of subjects enrolled 
New Zealand: 18


Country: Number of subjects enrolled 
Poland: 299


Country: Number of subjects enrolled 
Romania: 31


Country: Number of subjects enrolled 
Russian Federation: 118


Country: Number of subjects enrolled 
Serbia: 21


Worldwide total number of subjects 
1759


EEA total number of subjects 
536


Number of subjects enrolled per age group 

In utero 
0


Preterm newborn  gestational age < 37 wk 
0


Newborns (027 days) 
0


Infants and toddlers (28 days23 months) 
0


Children (211 years) 
0


Adolescents (1217 years) 
0


Adults (1864 years) 
1425


From 65 to 84 years 
333


85 years and over 
1



Recruitment


Recruitment details 
Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019.  
Preassignment


Screening details 
2582 participants were screened. Completed in the 'Placebo never received Filgotinib' arm included participants who completed 24 weeks of placebo treatment and were not rerandomized to Filgotinib 200 mg or 100 mg groups.  
Period 1


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  
Arms


Are arms mutually exclusive 
Yes


Arm title

Filgotinib 200 mg  
Arm description 
Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match [PTM] filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
Filgotinib


Investigational medicinal product code 

Other name 
GS6034, GLPG0634


Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
200 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 100 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 100 mg administered once daily


Investigational medicinal product name 
PTM Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
PTM adalimumab 40 mg administered once every 2 weeks


Arm title

Filgotinib 100 mg  
Arm description 
Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
Filgotinib


Investigational medicinal product code 

Other name 
GS6034, GLPG0634


Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
100 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 200 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 200 mg administered once daily


Investigational medicinal product name 
PTM Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
PTM adalimumab 40 mg administered once every 2 weeks


Arm title

Adalimumab  
Arm description 
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Arm type 
Active comparator  
Investigational medicinal product name 
PTM Filgotinib 200 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 200 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 100 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 100 mg administered once daily


Investigational medicinal product name 
Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
40 mg administered once every 2 weeks


Arm title

Placebo to Filgotinib 200 mg  
Arm description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
PTM Filgotinib 200 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 200 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 100 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 100 mg administered once daily


Investigational medicinal product name 
PTM Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
PTM adalimumab 40 mg administered once every 2 weeks


Investigational medicinal product name 
Filgotinib


Investigational medicinal product code 

Other name 
GS6034, GLPG0634


Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
200 mg administered once daily


Arm title

Placebo to Filgotinib 100 mg  
Arm description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.  
Arm type 
Experimental  
Investigational medicinal product name 
PTM Filgotinib 200 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 200 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 100 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 100 mg administered once daily


Investigational medicinal product name 
PTM Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
PTM adalimumab 40 mg administered once every 2 weeks


Investigational medicinal product name 
Filgotinib


Investigational medicinal product code 

Other name 
GS6034, GLPG0634


Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
100 mg administered once daily


Arm title

Placebo never received Filgotinib  
Arm description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks.  
Arm type 
Placebo  
Investigational medicinal product name 
PTM Filgotinib 200 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 200 mg administered once daily


Investigational medicinal product name 
PTM Filgotinib 100 mg


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Filmcoated tablet


Routes of administration 
Oral use


Dosage and administration details 
PTM filgotinib 100 mg administered once daily


Investigational medicinal product name 
PTM Adalimumab


Investigational medicinal product code 

Other name 

Pharmaceutical forms 
Injection


Routes of administration 
Subcutaneous use


Dosage and administration details 
PTM adalimumab 40 mg administered once every 2 weeks




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: Four participants who were randomized but did not receive the study drug are not included in analysis. 


Baseline characteristics reporting groups


Reporting group title 
Overall Study


Reporting group description 
  


Subject analysis sets


Subject analysis set title 
Filgotinib 200 mg


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of 52.1 weeks.


Subject analysis set title 
Filgotinib 100 mg


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.


Subject analysis set title 
Adalimumab


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.


Subject analysis set title 
Placebo


Subject analysis set type 
Full analysis  
Subject analysis set description 
The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.





End points reporting groups


Reporting group title 
Filgotinib 200 mg


Reporting group description 
Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match [PTM] filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Reporting group title 
Filgotinib 100 mg


Reporting group description 
Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Reporting group title 
Adalimumab


Reporting group description 
Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.  
Reporting group title 
Placebo to Filgotinib 200 mg


Reporting group description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.  
Reporting group title 
Placebo to Filgotinib 100 mg


Reporting group description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 28.1 weeks.  
Reporting group title 
Placebo never received Filgotinib


Reporting group description 
Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks.  
Subject analysis set title 
Filgotinib 200 mg


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of 52.1 weeks.


Subject analysis set title 
Filgotinib 100 mg


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.


Subject analysis set title 
Adalimumab


Subject analysis set type 
Full analysis  
Subject analysis set description 
Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 52.1 weeks.


Subject analysis set title 
Placebo


Subject analysis set type 
Full analysis  
Subject analysis set description 
The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.



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 (HAQDI) 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);highsensitivity Creactive 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 nonresponders.


End point type 
Primary


End point timeframe 
Week 12




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[1]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
26.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
20.6  
upper limit 
32.8  
Notes [1]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[2]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.6  
upper limit 
26.2  
Notes [2]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants who Achieved Disease Activity Score for 28 Joint Count Using CReactive 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 for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants in the Full Analysis Set were analyzed. Participants with missing outcomes were set as nonresponders.


End point type 
Secondary


End point timeframe 
Week 12




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[3]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
26.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
20.2  
upper limit 
32.4  
Notes [3]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[4]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
15.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.4  
upper limit 
21.4  
Notes [4]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Adalimumab  
Comparison groups 
Filgotinib 200 mg v Adalimumab


Number of subjects included in analysis 
800


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[5]}  
Pvalue 
< 0.001 ^{[6]}  
Method 
Method proposed by [Liu 2014]  
Confidence interval 

Notes [5]  For noninferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI. [6]  Pvalue of noninferiority test was calculated from approach proposed by [Liu 2014]. 

Statistical analysis title 
Filgotinib 100 mg vs Adalimumab  
Comparison groups 
Filgotinib 100 mg v Adalimumab


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
noninferiority ^{[7]}  
Pvalue 
= 0.054 ^{[8]}  
Method 
Method proposed by [Liu 2014]  
Confidence interval 

Notes [7]  For noninferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI. [8]  Pvalue of noninferiority test was calculated from approach proposed by [Liu 2014]. 

Statistical analysis title 
Filgotinib 200 mg vs Adalimumab  
Comparison groups 
Filgotinib 200 mg v Adalimumab


Number of subjects included in analysis 
800


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.069 ^{[9]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
6.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1  
upper limit 
13.6  
Notes [9]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Adalimumab  
Comparison groups 
Filgotinib 100 mg v Adalimumab


Number of subjects included in analysis 
805


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.18 ^{[10]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
4.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.8  
upper limit 
2.6  
Notes [10]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Change from Baseline in the Health Assessment QuestionnaireDisability Index (HAQDI) Score at Week 12  
End point description 
The HAQDI 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 HAQDI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are nonmissing, total possible score is 3. If more than 2 categories are missing, the HAQDI 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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority ^{[11]}  
Pvalue 
< 0.001 ^{[12]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.29


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.36  
upper limit 
0.22  
Variability estimate 
Standard error of the mean


Dispersion value 
0.034


Notes [11]  Least squares (LS)Mean, 95% CI, and Pvalue were provided from mixed effects model for repeated measure (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures. [12]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority ^{[13]}  
Pvalue 
< 0.001 ^{[14]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.17


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.24  
upper limit 
0.1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.034


Notes [13]  LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures. [14]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 


End point title 
Percentage of Participants who Achieved DAS28 (CRP) < 2.6 at Week 24  
End point description 
The DAS28 score is a measure of the participant’s disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), Patient’s Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants in the Full Analysis Set were analyzed. Participants with missing outcomes were set as nonresponders.


End point type 
Secondary


End point timeframe 
Week 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[15]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
32.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
26.4  
upper limit 
38  
Notes [15]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[16]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.4  
upper limit 
24.6  
Notes [16]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Change from Baseline in Modified Total Sharp Score (mTSS) at Week 24  
End point description 
Participant`s radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0448]) is defined as the erosion score (range [0280]) plus the joint space narrowing (JSN) score (range [0168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces). Participants in the Full Analysis Set with available data were analyzed.


End point type 
Secondary


End point timeframe 
Baseline; Week 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
933


Analysis specification 
Prespecified


Analysis type 
superiority ^{[17]}  
Pvalue 
< 0.001 ^{[18]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.27


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.43  
upper limit 
0.12  
Variability estimate 
Standard error of the mean


Dispersion value 
0.078


Notes [17]  LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures. [18]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
937


Analysis specification 
Prespecified


Analysis type 
superiority ^{[19]}  
Pvalue 
= 0.001 ^{[20]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.25


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.4  
upper limit 
0.1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.078


Notes [19]  LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures. [20]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 


End point title 
Percentage of Participants who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[21]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.1  
upper limit 
10.9  
Notes [21]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[22]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
4.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.3  
upper limit 
7.3  
Notes [22]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[23]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
16.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.9  
upper limit 
20.9  
Notes [23]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[24]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3.1  
upper limit 
10.9  
Notes [24]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[25]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
27.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
21.4  
upper limit 
33.3  
Notes [25]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[26]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
16.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.9  
upper limit 
22.5  
Notes [26]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[27]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
24.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
18.3  
upper limit 
31  
Notes [27]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[28]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.1  
upper limit 
25.8  
Notes [28]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved ACR50 at Weeks 36 and 52 ^{[29]}  
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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [29]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.008 ^{[30]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
2.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
4.1  
Notes [30]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.18 ^{[31]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
2.2  
Notes [31]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[32]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
7.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.6  
upper limit 
10.6  
Notes [32]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.067 ^{[33]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
1.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.3  
upper limit 
4  
Notes [33]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[34]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14.6  
upper limit 
24.1  
Notes [34]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[35]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
11.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.5  
upper limit 
16.2  
Notes [35]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[36]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
21.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15.7  
upper limit 
26.9  
Notes [36]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[37]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
14.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.2  
upper limit 
20  
Notes [37]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved ACR70 at Weeks 36 and 52 ^{[38]}  
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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [38]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[39]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
22.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16.7  
upper limit 
27.9  
Notes [39]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[40]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
12.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.2  
upper limit 
17.9  
Notes [40]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[41]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.4  
upper limit 
26.1  
Notes [41]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[42]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
13.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.5  
upper limit 
20.2  
Notes [42]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[43]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
18.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13  
upper limit 
24.9  
Notes [43]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[44]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
18.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.6  
upper limit 
24.5  
Notes [44]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved ACR20 Response at Weeks 36 and 52 ^{[45]}  
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 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [45]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Change From Baseline in Individual ACR Component: HAQDI at Weeks 2, 4, and 24  
End point description 
The HAQDI 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 HAQDI 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 2, 4, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[46]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.17


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.22  
upper limit 
0.12  
Variability estimate 
Standard error of the mean


Dispersion value 
0.025


Notes [46]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[47]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.09


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.14  
upper limit 
0.04  
Variability estimate 
Standard error of the mean


Dispersion value 
0.025


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[48]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.19


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.24  
upper limit 
0.13  
Variability estimate 
Standard error of the mean


Dispersion value 
0.028


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[49]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.15  
upper limit 
0.04  
Variability estimate 
Standard error of the mean


Dispersion value 
0.028


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[50]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.27


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.34  
upper limit 
0.19  
Variability estimate 
Standard error of the mean


Dispersion value 
0.037


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[51]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.19


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.26  
upper limit 
0.11  
Variability estimate 
Standard error of the mean


Dispersion value 
0.037


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


End point title 
Change From Baseline in Individual ACR Component: HAQDI at Weeks 36 and 52 ^{[52]}  
End point description 
The HAQDI 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 HAQDI 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 36 and 52


Notes [52]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[53]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.01 ^{[54]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
0  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[55]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[56]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


Notes [56]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[57]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[58]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.6


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[59]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.5


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[60]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.5


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


End point title 
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36 and 52 ^{[61]}  
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 36 and 52


Notes [61]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.002 ^{[62]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
0  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


Notes [62]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.047 ^{[63]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
0  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


Notes [63]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[64]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


Notes [64]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[65]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


Notes [65]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[66]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


Notes [66]  MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[67]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.4


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[68]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
3  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.3


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[69]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2  
upper limit 
1  
Variability estimate 
Standard error of the mean


Dispersion value 
0.3


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


End point title 
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36 and 52 ^{[70]}  
End point description 
The total SJC66 was based on 66 joints. 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 36 and 52


Notes [70]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[71]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[72]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[73]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.3


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[74]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7  
upper limit 
2  
Variability estimate 
Standard error of the mean


Dispersion value 
1.3


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[75]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
13


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
16  
upper limit 
10  
Variability estimate 
Standard error of the mean


Dispersion value 
1.5


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[76]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
10


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.5


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[77]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
11


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.6


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[78]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11  
upper limit 
5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.6


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


End point title 
Change From Baseline in Individual ACR Component: SGA at Weeks 36 and 52 ^{[79]}  
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 36 and 52


Notes [79]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[80]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10  
upper limit 
6  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[81]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8  
upper limit 
4  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[82]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11  
upper limit 
6  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[83]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9  
upper limit 
5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[84]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10  
upper limit 
6  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[85]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10  
upper limit 
5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[86]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11  
upper limit 
6  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[87]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10  
upper limit 
5  
Variability estimate 
Standard error of the mean


Dispersion value 
1.1


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


End point title 
Change From Baseline in Individual ACR Component: PGA at Weeks 36 and 52 ^{[88]}  
End point description 
PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement. Participants in the Full Analysis Set with available data were analyzed.


End point type 
Secondary


End point timeframe 
Baseline; Weeks 36 and 52


Notes [88]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[89]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[90]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8  
upper limit 
3  
Variability estimate 
Standard error of the mean


Dispersion value 
1.2


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[91]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.3


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[92]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9  
upper limit 
4  
Variability estimate 
Standard error of the mean


Dispersion value 
1.3


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[93]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
12


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
15  
upper limit 
9  
Variability estimate 
Standard error of the mean


Dispersion value 
1.5


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[94]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
10


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.5


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[95]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
11


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14  
upper limit 
7  
Variability estimate 
Standard error of the mean


Dispersion value 
1.6


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[96]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12  
upper limit 
6  
Variability estimate 
Standard error of the mean


Dispersion value 
1.6


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


End point title 
Change From Baseline in Individual ACR Component: Subject`s Pain Assessment at Weeks 36 and 52 ^{[97]}  
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 36 and 52


Notes [97]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Change From Baseline in Individual ACR Component: HighSensitivity CReactive Protein (hsCRP) at Weeks 2, 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 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[98]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
10.83


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
12.7  
upper limit 
8.96  
Variability estimate 
Standard error of the mean


Dispersion value 
0.952


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[99]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.73


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.58  
upper limit 
5.87  
Variability estimate 
Standard error of the mean


Dispersion value 
0.947


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[100]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
9.39


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.33  
upper limit 
7.45  
Variability estimate 
Standard error of the mean


Dispersion value 
0.989


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[101]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.35


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.29  
upper limit 
5.42  
Variability estimate 
Standard error of the mean


Dispersion value 
0.987


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[102]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
8.02


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.9  
upper limit 
6.13  
Variability estimate 
Standard error of the mean


Dispersion value 
0.961


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[103]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6.46


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.35  
upper limit 
4.58  
Variability estimate 
Standard error of the mean


Dispersion value 
0.96


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[104]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
7.91


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.88  
upper limit 
5.93  
Variability estimate 
Standard error of the mean


Dispersion value 
1.007


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[105]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
6.59


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
8.56  
upper limit 
4.62  
Variability estimate 
Standard error of the mean


Dispersion value 
1.005


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


End point title 
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36 and 52 ^{[106]}  
End point description 
Participants in the Full Analysis Set with available data were analyzed.


End point type 
Secondary


End point timeframe 
Baseline; Weeks 36 and 52


Notes [106]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQDI Score ≥ 0.22 at Weeks 2, 4, 12, and 24  
End point description 
The HAQDI 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 HAQDI score on a scale from 03 [0 (no disability) to 3 (completely disabled) when 6 or more categories are nonmissing, so total possible score is 3. Improvement is defined as reduction in HAQDI, (baseline value  postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQDI score is set to missing. Participants with missing outcomes were set as nonresponders. Participants in the Full Analysis Set with available data were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[107]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
12.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.7  
upper limit 
18.9  
Notes [107]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.043 ^{[108]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
6.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.1  
upper limit 
13.1  
Notes [108]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[109]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
16.3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.8  
upper limit 
22.8  
Notes [109]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.011 ^{[110]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
8.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.5  
upper limit 
14.7  
Notes [110]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[111]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
21


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
14.9  
upper limit 
27  
Notes [111]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[112]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
13.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.3  
upper limit 
19.9  
Notes [112]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[113]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
16.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
10.5  
upper limit 
22.8  
Notes [113]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[114]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
14.1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.8  
upper limit 
20.3  
Notes [114]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQDI Score ≥ 0.22 at Weeks 36 and 52 ^{[115]}  
End point description 
The HAQDI 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 HAQDI score on a scale from 03 [0 (no disability) to 3 (completely disabled) when 6 or more categories are nonmissing, so total possible score is 3. Improvement is defined as reduction in HAQDI, (baseline value  postbaseline value) ≥ 0.22. If more than 2 categories are missing, the HAQDI score is set to missing. Participants with missing outcomes were set as nonresponders. Participants in the Full Analysis Set with available data were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [115]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Change From Baseline in DAS28 (CRP) at Weeks 2, 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 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[116]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.9  
upper limit 
0.6  
Variability estimate 
Standard error of the mean


Dispersion value 
0.06


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[117]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
0.3  
Variability estimate 
Standard error of the mean


Dispersion value 
0.06


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[118]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.9  
upper limit 
0.7  
Variability estimate 
Standard error of the mean


Dispersion value 
0.07


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[119]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.7  
upper limit 
0.4  
Variability estimate 
Standard error of the mean


Dispersion value 
0.07


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[120]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.1  
upper limit 
0.8  
Variability estimate 
Standard error of the mean


Dispersion value 
0.07


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[121]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
0.5  
Variability estimate 
Standard error of the mean


Dispersion value 
0.07


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[122]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.1  
upper limit 
0.8  
Variability estimate 
Standard error of the mean


Dispersion value 
0.08


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[123]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
0.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.8  
upper limit 
0.5  
Variability estimate 
Standard error of the mean


Dispersion value 
0.08


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


End point title 
Change From Baseline in DAS28 (CRP) at Weeks 36 and 52 ^{[124]}  
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 36 and 52


Notes [124]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[125]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
9.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.8  
upper limit 
13.1  
Notes [125]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.004 ^{[126]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
4.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
1.4  
upper limit 
7.7  
Notes [126]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[127]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
16.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
11.3  
upper limit 
21.1  
Notes [127]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[128]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
11.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.5  
upper limit 
15.8  
Notes [128]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[129]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
26.9


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
20.6  
upper limit 
33.3  
Notes [129]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 24


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[130]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
19.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
13.1  
upper limit 
25.8  
Notes [130]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36 and 52 ^{[131]}  
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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [131]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 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), 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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 2, 4, and 12




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[132]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
4.4


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.1  
upper limit 
6.7  
Notes [132]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
= 0.17 ^{[133]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
1


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
0.5  
upper limit 
2.6  
Notes [133]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[134]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
10.7


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
7.1  
upper limit 
14.4  
Notes [134]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[135]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
5.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
2.6  
upper limit 
9  
Notes [135]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[136]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
24.8


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
19.6  
upper limit 
30  
Notes [136]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 12


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[137]}  
Method 
Regression, Logistic  
Parameter type 
Difference in Response Rates  
Point estimate 
14.5


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
9.7  
upper limit 
19.3  
Notes [137]  Pvalue was calculated from the logistic regression with treatment groups and stratification factors in the model. 


End point title 
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36 and 52 ^{[138]}  
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 nonresponders. Participants in the Full Analysis Set were analyzed.


End point type 
Secondary


End point timeframe 
Weeks 36 and 52


Notes [138]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
American College of Rheumatology N Percent Improvement (ACRN) at Weeks 2, 4, 12, and 24  
End point description 
ACRN 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, HAQDI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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). If this calculation results in a negative value, then the ACRN is set to 0. The ACRN 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 2, 4, 12, and 24




No statistical analyses for this end point 


End point title 
ACR N Percent Improvement (ACRN) at Weeks 36 and 52 ^{[139]}  
End point description 
ACRN 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, HAQDI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0100 [0 and 100 indicating no disease activity and maximum disease activity]; subject`s pain assessment using VAS on a scale of 0100 [0 and 100 indicating no pain and unbearable pain]; HAQDI 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). If this calculation results in a negative value, then the ACRN is set to 0. The ACRN 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 36 and 52


Notes [139]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


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




No statistical analyses for this end point 


End point title 
Number of Participants With EULAR Response at Weeks 36 and 52 ^{[140]}  
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 36 and 52


Notes [140]  The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Not applicable for the arm 'Placebo never received Filgotinib' at the specified time points. 



No statistical analyses for this end point 


End point title 
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 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 010 [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 2, 4, 12, and 24




Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[141]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
4.6


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
5.9  
upper limit 
3.2  
Variability estimate 
Standard error of the mean


Dispersion value 
0.68


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 2; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[142]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
3


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
4.3  
upper limit 
1.6  
Variability estimate 
Standard error of the mean


Dispersion value 
0.68


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

Statistical analysis title 
Filgotinib 200 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 200 mg v Placebo


Number of subjects included in analysis 
950


Analysis specification 
Prespecified


Analysis type 
superiority  
Pvalue 
< 0.001 ^{[143]}  
Method 
MMRM  
Parameter type 
Least Squares Mean Difference  
Point estimate 
5.2


Confidence interval 

level 
95%  
sides 
2sided


lower limit 
6.6  
upper limit 
3.8  
Variability estimate 
Standard error of the mean


Dispersion value 
0.73


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

Statistical analysis title 
Filgotinib 100 mg vs Placebo  
Statistical analysis description 
Week 4; LSMean, 95% CI, and Pvalue were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variancecovariance matrix for the repeated measures.


Comparison groups 
Filgotinib 100 mg v Placebo


Number of subjects included in analysis 
955

