Trial Outcomes & Findings for Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (NCT NCT02886728)

Last Updated: 2021-06-01

Results Overview

ACR20 response is achieved when the participant has: ≥ 20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1252 participants

Primary outcome timeframe

Week 24

Results posted on

2021-06-01

Participant Flow

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

1855 participants were screened.

Participant milestones

Participant milestones
Measure	Filgotinib 200 mg + MTX Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Study STARTED	417	207	210	418
Overall Study COMPLETED	345	175	174	331
Overall Study NOT COMPLETED	72	32	36	87

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgotinib 200 mg + MTX Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Study Withdrew Consent	31	13	11	47
Overall Study Lost to Follow-up	12	6	13	12
Overall Study Adverse Event	13	5	5	11
Overall Study Investigator's Discretion	11	7	5	11
Overall Study Death	3	1	0	0
Overall Study Protocol Violation	0	0	0	4
Overall Study Non-Compliance with Study Drug	1	0	1	0
Overall Study Pregnancy	0	0	1	0
Overall Study Randomized but Not Dosed	1	0	0	2

Baseline Characteristics

Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.	Total n=1249 Participants Total of all reporting groups
Region of Enrollment Spain	12 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	10 Participants n=4 Participants	34 Participants n=21 Participants
Region of Enrollment Germany	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	30 Participants n=21 Participants
Region of Enrollment South Korea	6 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	24 Participants n=21 Participants
Region of Enrollment Canada	5 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	20 Participants n=21 Participants
Age, Continuous	53 years STANDARD_DEVIATION 13.8 • n=5 Participants	54 years STANDARD_DEVIATION 12.6 • n=7 Participants	52 years STANDARD_DEVIATION 13.9 • n=5 Participants	53 years STANDARD_DEVIATION 13.7 • n=4 Participants	53 years STANDARD_DEVIATION 13.6 • n=21 Participants
Sex: Female, Male Female	325 Participants n=5 Participants	158 Participants n=7 Participants	166 Participants n=5 Participants	312 Participants n=4 Participants	961 Participants n=21 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	49 Participants n=7 Participants	44 Participants n=5 Participants	104 Participants n=4 Participants	288 Participants n=21 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	26 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants	33 Participants n=4 Participants	89 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian: Japanese	23 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	25 Participants n=4 Participants	71 Participants n=21 Participants
Region of Enrollment Belgium	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	19 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian: Chinese/Taiwanese/Hong Kong Chinese	7 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	10 Participants n=4 Participants	27 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian: Vietnamese	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian: Korean	6 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	24 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian: Other	53 Participants n=5 Participants	28 Participants n=7 Participants	27 Participants n=5 Participants	42 Participants n=4 Participants	150 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black or African American	15 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	45 Participants n=21 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	278 Participants n=5 Participants	132 Participants n=7 Participants	135 Participants n=5 Participants	278 Participants n=4 Participants	823 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	6 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Race · Not Permitted	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	93 Participants n=5 Participants	40 Participants n=7 Participants	45 Participants n=5 Participants	84 Participants n=4 Participants	262 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	322 Participants n=5 Participants	167 Participants n=7 Participants	165 Participants n=5 Participants	332 Participants n=4 Participants	986 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	112 Participants n=5 Participants	47 Participants n=7 Participants	54 Participants n=5 Participants	106 Participants n=4 Participants	319 Participants n=21 Participants
Region of Enrollment South Africa	8 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	19 Participants n=21 Participants
Region of Enrollment Australia	7 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment New Zealand	9 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment United Kingdom	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Italy	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Ireland	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Israel	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment India	41 Participants n=5 Participants	21 Participants n=7 Participants	22 Participants n=5 Participants	31 Participants n=4 Participants	115 Participants n=21 Participants
Region of Enrollment Poland	35 Participants n=5 Participants	21 Participants n=7 Participants	15 Participants n=5 Participants	37 Participants n=4 Participants	108 Participants n=21 Participants
Region of Enrollment Ukraine	21 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants	69 Participants n=21 Participants
Region of Enrollment Bulgaria	17 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants	54 Participants n=21 Participants
Region of Enrollment Russia	9 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants	31 Participants n=21 Participants
Region of Enrollment Czechia	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	20 Participants n=21 Participants
Region of Enrollment Hungary	7 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	18 Participants n=21 Participants
Region of Enrollment Serbia	6 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	16 Participants n=21 Participants
Region of Enrollment Romania	4 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	10 Participants n=21 Participants
Region of Enrollment Slovakia	4 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment Mexico	35 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	38 Participants n=4 Participants	116 Participants n=21 Participants
Region of Enrollment Argentina	16 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants	40 Participants n=21 Participants
Region of Enrollment Chile	7 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Taiwan	7 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	9 Participants n=4 Participants	23 Participants n=21 Participants
Region of Enrollment Thailand	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	13 Participants n=21 Participants
Region of Enrollment Malaysia	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Region of Enrollment Hong Kong	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants
Region of Enrollment Japan	23 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	25 Participants n=4 Participants	71 Participants n=21 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24	81.0 percentage of participants Interval 77.1 to 84.9	80.2 percentage of participants Interval 74.5 to 85.9	78.1 percentage of participants Interval 72.3 to 83.9	71.4 percentage of participants Interval 66.9 to 75.9

SECONDARY outcome

Timeframe: Baseline; Week 24

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 Baseline	1.52 score on a scale Standard Deviation 0.622	1.56 score on a scale Standard Deviation 0.654	1.56 score on a scale Standard Deviation 0.655	1.60 score on a scale Standard Deviation 0.625
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 Change at Week 24	-0.94 score on a scale Standard Deviation 0.722	-0.90 score on a scale Standard Deviation 0.675	-0.89 score on a scale Standard Deviation 0.631	-0.79 score on a scale Standard Deviation 0.634

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24	54.1 percentage of participants Interval 49.2 to 59.0	42.5 percentage of participants Interval 35.5 to 49.5	42.4 percentage of participants Interval 35.5 to 49.3	29.1 percentage of participants Interval 24.6 to 33.6

SECONDARY outcome

Timeframe: Baseline; Week 24

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 Baseline	11.35 score on a scale Standard Deviation 19.922	13.31 score on a scale Standard Deviation 26.980	16.53 score on a scale Standard Deviation 32.372	13.72 score on a scale Standard Deviation 29.168
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 Change at Week 24	0.21 score on a scale Standard Deviation 1.684	0.22 score on a scale Standard Deviation 1.526	-0.04 score on a scale Standard Deviation 1.710	0.51 score on a scale Standard Deviation 2.887

SECONDARY outcome

Timeframe: Baseline; Week 24

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 Baseline	33.9 score on a scale Standard Deviation 7.48	33.7 score on a scale Standard Deviation 8.00	33.6 score on a scale Standard Deviation 7.70	33.3 score on a scale Standard Deviation 7.28
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 Change at Week 24	12.3 score on a scale Standard Deviation 8.89	11.1 score on a scale Standard Deviation 9.00	10.4 score on a scale Standard Deviation 9.09	9.7 score on a scale Standard Deviation 8.62

SECONDARY outcome

Timeframe: Baseline; Week 24

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 Baseline	28.3 score on a scale Standard Deviation 10.93	27.3 score on a scale Standard Deviation 11.92	27.3 score on a scale Standard Deviation 10.90	27.1 score on a scale Standard Deviation 10.72
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 Change at Week 24	10.6 score on a scale Standard Deviation 11.49	11.4 score on a scale Standard Deviation 11.26	10.2 score on a scale Standard Deviation 11.37	10.1 score on a scale Standard Deviation 11.19

SECONDARY outcome

Timeframe: Baseline; Week 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in the mTSS at Week 52 Baseline	11.31 score on a scale Standard Deviation 19.273	12.76 score on a scale Standard Deviation 24.363	15.89 score on a scale Standard Deviation 31.813	13.36 score on a scale Standard Deviation 27.736
Change From Baseline in the mTSS at Week 52 Change at Week 52	0.31 score on a scale Standard Deviation 1.808	0.23 score on a scale Standard Deviation 1.111	0.33 score on a scale Standard Deviation 1.902	0.81 score on a scale Standard Deviation 3.089

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, 36, and 52

Population: Participants in the Full Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 Week 2	42.1 percentage of participants Interval 37.2 to 46.9	37.2 percentage of participants Interval 30.4 to 44.0	39.5 percentage of participants Interval 32.7 to 46.4	16.6 percentage of participants Interval 12.9 to 20.3
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 Week 4	62.3 percentage of participants Interval 57.5 to 67.0	55.6 percentage of participants Interval 48.5 to 62.6	52.4 percentage of participants Interval 45.4 to 59.4	33.4 percentage of participants Interval 28.8 to 38.1
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 Week 12	76.7 percentage of participants Interval 72.5 to 80.9	72.0 percentage of participants Interval 65.6 to 78.3	71.4 percentage of participants Interval 65.1 to 77.8	59.4 percentage of participants Interval 54.5 to 64.2
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 Week 36	75.5 percentage of participants Interval 71.2 to 79.7	73.4 percentage of participants Interval 67.2 to 79.7	76.2 percentage of participants Interval 70.2 to 82.2	68.3 percentage of participants Interval 63.7 to 72.9
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 Week 52	75.0 percentage of participants Interval 70.7 to 79.3	73.4 percentage of participants Interval 67.2 to 79.7	74.8 percentage of participants Interval 68.6 to 80.9	61.8 percentage of participants Interval 57.0 to 66.6

SECONDARY outcome

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

Population: Participants in the Full Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 2	13.0 percentage of participants Interval 9.6 to 16.3	9.2 percentage of participants Interval 5.0 to 13.4	16.2 percentage of participants Interval 11.0 to 21.4	2.9 percentage of participants Interval 1.2 to 4.6
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 4	29.3 percentage of participants Interval 24.8 to 33.8	20.8 percentage of participants Interval 15.0 to 26.5	25.7 percentage of participants Interval 19.6 to 31.9	9.4 percentage of participants Interval 6.5 to 12.3
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 12	53.1 percentage of participants Interval 48.2 to 58.0	44.4 percentage of participants Interval 37.4 to 51.5	45.7 percentage of participants Interval 38.7 to 52.7	28.4 percentage of participants Interval 23.9 to 32.8
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 24	61.5 percentage of participants Interval 56.7 to 66.3	57.0 percentage of participants Interval 50.0 to 64.0	58.1 percentage of participants Interval 51.2 to 65.0	45.7 percentage of participants Interval 40.8 to 50.6
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 36	60.6 percentage of participants Interval 55.8 to 65.4	55.6 percentage of participants Interval 48.5 to 62.6	58.6 percentage of participants Interval 51.7 to 65.5	48.6 percentage of participants Interval 43.6 to 53.5
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 Week 52	62.3 percentage of participants Interval 57.5 to 67.0	59.4 percentage of participants Interval 52.5 to 66.4	61.4 percentage of participants Interval 54.6 to 68.3	48.3 percentage of participants Interval 43.4 to 53.2

SECONDARY outcome

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

Population: Participants in the Full Analysis Set were analyzed.

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 2	3.1 percentage of participants Interval 1.3 to 4.9	1.9 percentage of participants Interval 0.0 to 4.0	4.3 percentage of participants Interval 1.3 to 7.3	0.7 percentage of participants Interval 0.0 to 1.7
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 4	13.0 percentage of participants Interval 9.6 to 16.3	6.3 percentage of participants Interval 2.7 to 9.8	11.4 percentage of participants Interval 6.9 to 16.0	3.8 percentage of participants Interval 1.9 to 5.8
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 12	32.9 percentage of participants Interval 28.3 to 37.6	27.1 percentage of participants Interval 20.8 to 33.3	29.0 percentage of participants Interval 22.7 to 35.4	13.2 percentage of participants Interval 9.8 to 16.6
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 24	43.8 percentage of participants Interval 38.9 to 48.6	40.1 percentage of participants Interval 33.2 to 47.0	40.0 percentage of participants Interval 33.1 to 46.9	26.0 percentage of participants Interval 21.6 to 30.3
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 36	45.9 percentage of participants Interval 41.0 to 50.8	37.2 percentage of participants Interval 30.4 to 44.0	39.5 percentage of participants Interval 32.7 to 46.4	32.2 percentage of participants Interval 27.6 to 36.8
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 Week 52	47.8 percentage of participants Interval 42.9 to 52.8	40.1 percentage of participants Interval 33.2 to 47.0	45.2 percentage of participants Interval 38.3 to 52.2	29.8 percentage of participants Interval 25.3 to 34.3

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Baseline	1.52 score on a scale Standard Deviation 0.622	1.56 score on a scale Standard Deviation 0.654	1.56 score on a scale Standard Deviation 0.655	1.60 score on a scale Standard Deviation 0.625
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Change at Week 2	-0.37 score on a scale Standard Deviation 0.495	-0.36 score on a scale Standard Deviation 0.490	-0.32 score on a scale Standard Deviation 0.442	-0.18 score on a scale Standard Deviation 0.426
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Change at Week 4	-0.57 score on a scale Standard Deviation 0.587	-0.45 score on a scale Standard Deviation 0.547	-0.51 score on a scale Standard Deviation 0.526	-0.32 score on a scale Standard Deviation 0.511
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Change at Week 12	-0.85 score on a scale Standard Deviation 0.698	-0.77 score on a scale Standard Deviation 0.670	-0.76 score on a scale Standard Deviation 0.625	-0.61 score on a scale Standard Deviation 0.582
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Change at Week 36	-0.96 score on a scale Standard Deviation 0.725	-0.93 score on a scale Standard Deviation 0.700	-0.91 score on a scale Standard Deviation 0.673	-0.89 score on a scale Standard Deviation 0.675
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 Change at Week 52	-1.00 score on a scale Standard Deviation 0.728	-0.97 score on a scale Standard Deviation 0.719	-0.95 score on a scale Standard Deviation 0.688	-0.88 score on a scale Standard Deviation 0.685

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-13 tender joint count Standard Deviation 12.1	-12 tender joint count Standard Deviation 10.1	-13 tender joint count Standard Deviation 11.8	-8 tender joint count Standard Deviation 11.5
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-20 tender joint count Standard Deviation 12.5	-20 tender joint count Standard Deviation 13.0	-22 tender joint count Standard Deviation 12.4	-19 tender joint count Standard Deviation 12.9
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-21 tender joint count Standard Deviation 12.6	-21 tender joint count Standard Deviation 12.8	-23 tender joint count Standard Deviation 11.9	-21 tender joint count Standard Deviation 12.7
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-22 tender joint count Standard Deviation 12.4	-21 tender joint count Standard Deviation 13.0	-23 tender joint count Standard Deviation 12.3	-21 tender joint count Standard Deviation 12.6
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	26 tender joint count Standard Deviation 14.5	25 tender joint count Standard Deviation 13.9	26 tender joint count Standard Deviation 13.7	26 tender joint count Standard Deviation 13.8
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-9 tender joint count Standard Deviation 10.2	-8 tender joint count Standard Deviation 9.8	-9 tender joint count Standard Deviation 11.2	-5 tender joint count Standard Deviation 9.8
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-18 tender joint count Standard Deviation 12.5	-17 tender joint count Standard Deviation 12.4	-18 tender joint count Standard Deviation 12.4	-15 tender joint count Standard Deviation 12.2

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	16.0 swollen joint count Standard Deviation 9.8	16.0 swollen joint count Standard Deviation 9.3	16.0 swollen joint count Standard Deviation 9.7	16.0 swollen joint count Standard Deviation 9.4
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-7.0 swollen joint count Standard Deviation 8.0	-6.0 swollen joint count Standard Deviation 6.9	-7.0 swollen joint count Standard Deviation 8.1	-4.0 swollen joint count Standard Deviation 7.5
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-9.0 swollen joint count Standard Deviation 8.7	-9.0 swollen joint count Standard Deviation 7.6	-9.0 swollen joint count Standard Deviation 8.3	-6.0 swollen joint count Standard Deviation 9.2
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-14.0 swollen joint count Standard Deviation 9.1	-14.0 swollen joint count Standard Deviation 9.4	-15.0 swollen joint count Standard Deviation 9.7	-14.0 swollen joint count Standard Deviation 8.7
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-13.0 swollen joint count Standard Deviation 8.9	-12.0 swollen joint count Standard Deviation 8.1	-13.0 swollen joint count Standard Deviation 9.1	-11.0 swollen joint count Standard Deviation 8.9
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-14.0 swollen joint count Standard Deviation 8.9	-14.0 swollen joint count Standard Deviation 8.8	-15.0 swollen joint count Standard Deviation 9.5	-13.0 swollen joint count Standard Deviation 8.8
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-15.0 swollen joint count Standard Deviation 9.2	-14.0 swollen joint count Standard Deviation 8.9	-16.0 swollen joint count Standard Deviation 9.8	-14.0 swollen joint count Standard Deviation 9.0

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	65.0 score on a scale Standard Deviation 21.0	66.0 score on a scale Standard Deviation 21.6	68.0 score on a scale Standard Deviation 19.2	66.0 score on a scale Standard Deviation 21.0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-26.0 score on a scale Standard Deviation 24.7	-20.0 score on a scale Standard Deviation 22.5	-22.0 score on a scale Standard Deviation 24.6	-14.0 score on a scale Standard Deviation 22.2
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-37.0 score on a scale Standard Deviation 26.7	-30.0 score on a scale Standard Deviation 26.1	-32.0 score on a scale Standard Deviation 27.7	-25.0 score on a scale Standard Deviation 25.9
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-42.0 score on a scale Standard Deviation 26.8	-36.0 score on a scale Standard Deviation 27.4	-38.0 score on a scale Standard Deviation 26.6	-34.0 score on a scale Standard Deviation 27.4
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-43.0 score on a scale Standard Deviation 27.2	-39.0 score on a scale Standard Deviation 27.8	-39.0 score on a scale Standard Deviation 24.3	-38.0 score on a scale Standard Deviation 28.0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-45.0 score on a scale Standard Deviation 27.0	-41.0 score on a scale Standard Deviation 28.1	-43.0 score on a scale Standard Deviation 25.4	-38.0 score on a scale Standard Deviation 28.3
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-17.0 score on a scale Standard Deviation 20.8	-13.0 score on a scale Standard Deviation 18.9	-14.0 score on a scale Standard Deviation 20.7	-7.0 score on a scale Standard Deviation 18.9

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	66.0 score on a scale Standard Deviation 17.0	68.0 score on a scale Standard Deviation 16.3	66.0 score on a scale Standard Deviation 14.4	67.0 score on a scale Standard Deviation 16.8
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-24.0 score on a scale Standard Deviation 20.3	-21.0 score on a scale Standard Deviation 19.4	-23.0 score on a scale Standard Deviation 19.9	-15.0 score on a scale Standard Deviation 18.9
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-34.0 score on a scale Standard Deviation 22.3	-32.0 score on a scale Standard Deviation 22.5	-30.0 score on a scale Standard Deviation 21.9	-23.0 score on a scale Standard Deviation 20.7
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-47.0 score on a scale Standard Deviation 21.4	-43.0 score on a scale Standard Deviation 22.5	-42.0 score on a scale Standard Deviation 20.8	-38.0 score on a scale Standard Deviation 21.9
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-51.0 score on a scale Standard Deviation 21.1	-51.0 score on a scale Standard Deviation 22.2	-49.0 score on a scale Standard Deviation 19.5	-46.0 score on a scale Standard Deviation 21.4
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-53.0 score on a scale Standard Deviation 20.5	-51.0 score on a scale Standard Deviation 22.3	-52.0 score on a scale Standard Deviation 18.6	-51.0 score on a scale Standard Deviation 20.6
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-56.0 score on a scale Standard Deviation 20.0	-54.0 score on a scale Standard Deviation 20.7	-55.0 score on a scale Standard Deviation 17.5	-51.0 score on a scale Standard Deviation 20.2

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Baseline	64.0 score on a scale Standard Deviation 22.0	67.0 score on a scale Standard Deviation 22.1	67.0 score on a scale Standard Deviation 18.4	66.0 score on a scale Standard Deviation 21.4
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-18.0 score on a scale Standard Deviation 22.2	-15.0 score on a scale Standard Deviation 20.3	-17.0 score on a scale Standard Deviation 21.6	-7.0 score on a scale Standard Deviation 20.1
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-37.0 score on a scale Standard Deviation 27.1	-31.0 score on a scale Standard Deviation 26.9	-32.0 score on a scale Standard Deviation 28.3	-26.0 score on a scale Standard Deviation 27.0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-41.0 score on a scale Standard Deviation 28.0	-37.0 score on a scale Standard Deviation 27.8	-39.0 score on a scale Standard Deviation 26.1	-34.0 score on a scale Standard Deviation 27.6
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-45.0 score on a scale Standard Deviation 27.9	-43.0 score on a scale Standard Deviation 27.9	-44.0 score on a scale Standard Deviation 24.2	-37.0 score on a scale Standard Deviation 30.5
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-26.0 score on a scale Standard Deviation 24.8	-22.0 score on a scale Standard Deviation 23.7	-24.0 score on a scale Standard Deviation 25.3	-14.0 score on a scale Standard Deviation 23.6
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-43.0 score on a scale Standard Deviation 28.0	-40.0 score on a scale Standard Deviation 28.8	-38.0 score on a scale Standard Deviation 25.6	-38.0 score on a scale Standard Deviation 29.3

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	18.04 mg/L Standard Deviation 25.289	17.72 mg/L Standard Deviation 27.419	17.32 mg/L Standard Deviation 23.228	16.86 mg/L Standard Deviation 24.353
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-12.89 mg/L Standard Deviation 23.401	-9.40 mg/L Standard Deviation 18.930	-10.97 mg/L Standard Deviation 20.249	-0.99 mg/L Standard Deviation 14.392
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-13.79 mg/L Standard Deviation 23.569	-11.53 mg/L Standard Deviation 20.596	-10.95 mg/L Standard Deviation 23.319	-3.18 mg/L Standard Deviation 18.534
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-13.77 mg/L Standard Deviation 23.585	-11.02 mg/L Standard Deviation 20.272	-12.04 mg/L Standard Deviation 24.690	-7.23 mg/L Standard Deviation 21.823
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-13.43 mg/L Standard Deviation 27.086	-10.85 mg/L Standard Deviation 24.458	-12.66 mg/L Standard Deviation 24.525	-7.47 mg/L Standard Deviation 23.511
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-12.99 mg/L Standard Deviation 26.823	-12.64 mg/L Standard Deviation 22.736	-11.52 mg/L Standard Deviation 26.863	-8.74 mg/L Standard Deviation 23.579
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-13.84 mg/L Standard Deviation 25.180	-11.61 mg/L Standard Deviation 23.857	-12.29 mg/L Standard Deviation 23.090	-7.96 mg/L Standard Deviation 23.835

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 2	61.9 percentage of participants Interval 57.1 to 66.8	58.5 percentage of participants Interval 51.4 to 65.6	53.9 percentage of participants Interval 46.8 to 61.0	42.2 percentage of participants Interval 37.3 to 47.1
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 4	72.4 percentage of participants Interval 67.9 to 76.9	61.0 percentage of participants Interval 54.0 to 68.0	68.6 percentage of participants Interval 62.0 to 75.2	53.9 percentage of participants Interval 49.0 to 58.8
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 12	80.3 percentage of participants Interval 76.3 to 84.4	74.5 percentage of participants Interval 68.2 to 80.8	74.0 percentage of participants Interval 67.8 to 80.3	69.8 percentage of participants Interval 65.2 to 74.3
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 24	76.6 percentage of participants Interval 72.4 to 80.9	78.5 percentage of participants Interval 72.6 to 84.4	77.0 percentage of participants Interval 70.9 to 83.0	73.9 percentage of participants Interval 69.5 to 78.3
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 36	73.4 percentage of participants Interval 68.9 to 77.8	76.5 percentage of participants Interval 70.4 to 82.6	73.5 percentage of participants Interval 67.2 to 79.8	67.1 percentage of participants Interval 62.4 to 71.7
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, 24, 36, and 52 Week 52	70.9 percentage of participants Interval 66.3 to 75.5	71.5 percentage of participants Interval 65.0 to 78.0	70.6 percentage of participants Interval 64.1 to 77.1	61.0 percentage of participants Interval 56.1 to 65.8

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	5.7 score on a scale Standard Deviation 0.99	5.7 score on a scale Standard Deviation 1.04	5.8 score on a scale Standard Deviation 0.94	5.7 score on a scale Standard Deviation 1.00
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-1.3 score on a scale Standard Deviation 1.06	-1.1 score on a scale Standard Deviation 0.92	-1.4 score on a scale Standard Deviation 1.12	-0.6 score on a scale Standard Deviation 0.87
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-1.9 score on a scale Standard Deviation 1.26	-1.6 score on a scale Standard Deviation 1.14	-1.8 score on a scale Standard Deviation 1.20	-1.0 score on a scale Standard Deviation 1.04
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-3.2 score on a scale Standard Deviation 1.31	-2.9 score on a scale Standard Deviation 1.30	-3.0 score on a scale Standard Deviation 1.16	-2.5 score on a scale Standard Deviation 1.29
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-3.4 score on a scale Standard Deviation 1.23	-3.1 score on a scale Standard Deviation 1.24	-3.3 score on a scale Standard Deviation 1.11	-2.8 score on a scale Standard Deviation 1.29
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-2.7 score on a scale Standard Deviation 1.31	-2.5 score on a scale Standard Deviation 1.28	-2.6 score on a scale Standard Deviation 1.26	-1.9 score on a scale Standard Deviation 1.21
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-3.3 score on a scale Standard Deviation 1.28	-3.0 score on a scale Standard Deviation 1.26	-3.2 score on a scale Standard Deviation 1.12	-2.9 score on a scale Standard Deviation 1.22

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, and 52

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 Week 4	30.8 percentage of participants Interval 26.2 to 35.3	23.7 percentage of participants Interval 17.6 to 29.7	31.9 percentage of participants Interval 25.4 to 38.4	12.0 percentage of participants Interval 8.8 to 15.3
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 Week 12	55.8 percentage of participants Interval 50.9 to 60.7	50.2 percentage of participants Interval 43.2 to 57.3	48.1 percentage of participants Interval 41.1 to 55.1	28.6 percentage of participants Interval 24.1 to 33.1
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 Week 24	68.8 percentage of participants Interval 64.2 to 73.3	62.8 percentage of participants Interval 56.0 to 69.6	60.0 percentage of participants Interval 53.1 to 66.9	46.2 percentage of participants Interval 41.2 to 51.1
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, 12, 24, and 52 Week 52	69.0 percentage of participants Interval 64.4 to 73.6	59.9 percentage of participants Interval 53.0 to 66.8	65.7 percentage of participants Interval 59.1 to 72.4	47.6 percentage of participants Interval 42.7 to 52.5

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, 36, and 52

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 Week 2	7.2 percentage of participants Interval 4.6 to 9.8	4.3 percentage of participants Interval 1.3 to 7.4	10.0 percentage of participants Interval 5.7 to 14.3	1.0 percentage of participants Interval 0.0 to 2.0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 Week 4	16.6 percentage of participants Interval 12.9 to 20.3	15.0 percentage of participants Interval 9.9 to 20.1	19.5 percentage of participants Interval 13.9 to 25.1	4.8 percentage of participants Interval 2.6 to 7.0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 Week 12	39.7 percentage of participants Interval 34.8 to 44.5	31.9 percentage of participants Interval 25.3 to 38.5	29.5 percentage of participants Interval 23.1 to 35.9	17.1 percentage of participants Interval 13.3 to 20.8
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 Week 36	52.6 percentage of participants Interval 47.7 to 57.6	42.0 percentage of participants Interval 35.1 to 49.0	43.3 percentage of participants Interval 36.4 to 50.3	34.4 percentage of participants Interval 29.7 to 39.1
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 Week 52	53.4 percentage of participants Interval 48.5 to 58.3	43.0 percentage of participants Interval 36.0 to 50.0	46.2 percentage of participants Interval 39.2 to 53.2	31.5 percentage of participants Interval 26.9 to 36.1

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 4	34.1 percent improvement Standard Deviation 27.78	27.6 percent improvement Standard Deviation 24.81	29.4 percent improvement Standard Deviation 27.86	17.2 percent improvement Standard Deviation 21.43
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 12	52.6 percent improvement Standard Deviation 29.91	46.1 percent improvement Standard Deviation 31.46	48.6 percent improvement Standard Deviation 30.50	34.3 percent improvement Standard Deviation 28.07
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 24	62.8 percent improvement Standard Deviation 28.40	58.1 percent improvement Standard Deviation 30.19	59.7 percent improvement Standard Deviation 29.35	49.0 percent improvement Standard Deviation 29.46
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 36	65.8 percent improvement Standard Deviation 28.50	58.7 percent improvement Standard Deviation 30.99	62.1 percent improvement Standard Deviation 28.12	57.3 percent improvement Standard Deviation 29.16
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 52	69.6 percent improvement Standard Deviation 27.38	63.6 percent improvement Standard Deviation 29.19	67.4 percent improvement Standard Deviation 26.60	57.1 percent improvement Standard Deviation 29.59
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 2	20.8 percent improvement Standard Deviation 21.42	17.8 percent improvement Standard Deviation 20.07	20.9 percent improvement Standard Deviation 23.19	8.9 percent improvement Standard Deviation 14.95

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 2 · Good Response	66 Participants	21 Participants	35 Participants	20 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 2 · Moderate Response	199 Participants	92 Participants	88 Participants	118 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 2 · No Response	134 Participants	86 Participants	77 Participants	258 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 4 · Good Response	120 Participants	45 Participants	63 Participants	45 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 4 · Moderate Response	206 Participants	104 Participants	97 Participants	161 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 4 · No Response	77 Participants	50 Participants	42 Participants	195 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 12 · Good Response	230 Participants	100 Participants	98 Participants	116 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 12 · No Response	26 Participants	16 Participants	14 Participants	74 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 24 · Moderate Response	82 Participants	55 Participants	52 Participants	153 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 24 · No Response	9 Participants	8 Participants	5 Participants	29 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 36 · Good Response	276 Participants	118 Participants	124 Participants	208 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 36 · Moderate Response	64 Participants	54 Participants	51 Participants	106 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 36 · No Response	7 Participants	5 Participants	2 Participants	7 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 52 · Good Response	286 Participants	123 Participants	136 Participants	194 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 52 · Moderate Response	43 Participants	43 Participants	30 Participants	102 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 52 · No Response	3 Participants	4 Participants	3 Participants	11 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 12 · Moderate Response	130 Participants	79 Participants	77 Participants	190 Participants
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 Week 24 · Good Response	283 Participants	127 Participants	126 Participants	186 Participants

SECONDARY outcome

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

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

CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	39.5 score on a scale Standard Deviation 12.77	39.2 score on a scale Standard Deviation 12.69	40.0 score on a scale Standard Deviation 12.63	40.2 score on a scale Standard Deviation 12.50
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-13.6 score on a scale Standard Deviation 12.05	-12.0 score on a scale Standard Deviation 10.54	-13.9 score on a scale Standard Deviation 12.53	-8.5 score on a scale Standard Deviation 11.33
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-27.8 score on a scale Standard Deviation 13.60	-26.1 score on a scale Standard Deviation 13.00	-27.5 score on a scale Standard Deviation 13.55	-22.7 score on a scale Standard Deviation 13.38
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-31.3 score on a scale Standard Deviation 13.19	-30.0 score on a scale Standard Deviation 13.32	-31.3 score on a scale Standard Deviation 12.57	-28.2 score on a scale Standard Deviation 13.43
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-33.8 score on a scale Standard Deviation 13.00	-31.9 score on a scale Standard Deviation 12.22	-33.6 score on a scale Standard Deviation 12.28	-31.2 score on a scale Standard Deviation 13.12
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-19.9 score on a scale Standard Deviation 13.64	-17.8 score on a scale Standard Deviation 12.06	-18.4 score on a scale Standard Deviation 12.96	-13.3 score on a scale Standard Deviation 12.61
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-32.2 score on a scale Standard Deviation 13.37	-30.8 score on a scale Standard Deviation 12.84	-32.7 score on a scale Standard Deviation 12.16	-31.3 score on a scale Standard Deviation 12.66

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Baseline	41.3 score on a scale Standard Deviation 13.41	41.0 score on a scale Standard Deviation 13.53	41.8 score on a scale Standard Deviation 13.09	41.9 score on a scale Standard Deviation 13.39
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 4	-21.3 score on a scale Standard Deviation 14.17	-19.0 score on a scale Standard Deviation 12.58	-19.6 score on a scale Standard Deviation 13.38	-13.7 score on a scale Standard Deviation 12.83
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 12	-29.2 score on a scale Standard Deviation 14.05	-27.1 score on a scale Standard Deviation 13.59	-28.6 score on a scale Standard Deviation 14.02	-23.5 score on a scale Standard Deviation 13.82
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 36	-33.5 score on a scale Standard Deviation 14.02	-32.1 score on a scale Standard Deviation 13.61	-33.9 score on a scale Standard Deviation 12.67	-32.3 score on a scale Standard Deviation 13.47
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 52	-35.2 score on a scale Standard Deviation 13.68	-33.0 score on a scale Standard Deviation 13.12	-35.0 score on a scale Standard Deviation 12.69	-32.0 score on a scale Standard Deviation 14.14
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 2	-14.9 score on a scale Standard Deviation 12.45	-12.9 score on a scale Standard Deviation 10.84	-15.0 score on a scale Standard Deviation 12.82	-8.6 score on a scale Standard Deviation 11.49
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 Change at Week 24	-32.7 score on a scale Standard Deviation 13.83	-31.1 score on a scale Standard Deviation 14.09	-32.7 score on a scale Standard Deviation 13.14	-29.0 score on a scale Standard Deviation 14.09

SECONDARY outcome

Timeframe: Baseline; Weeks 24, and 52

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 24: Change in mTSS ≤ 0.5	89.6 percentage of participants Interval 86.3 to 92.9	87.0 percentage of participants Interval 81.8 to 92.1	89.6 percentage of participants Interval 84.8 to 94.4	82.0 percentage of participants Interval 77.9 to 86.2
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 24: Change in mTSS ≤ 0	80.6 percentage of participants Interval 76.3 to 84.8	76.6 percentage of participants Interval 70.2 to 83.0	82.7 percentage of participants Interval 76.7 to 88.6	72.5 percentage of participants Interval 67.7 to 77.3
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 24: Change in mTSS ≤ SDC (1.53)	95.2 percentage of participants Interval 92.8 to 97.6	93.5 percentage of participants Interval 89.6 to 97.3	96.0 percentage of participants Interval 92.7 to 99.2	91.6 percentage of participants Interval 88.5 to 94.6
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 52: Change in mTSS ≤ 0.5	88.1 percentage of participants Interval 84.6 to 91.7	85.8 percentage of participants Interval 80.4 to 91.2	84.3 percentage of participants Interval 78.5 to 90.2	77.9 percentage of participants Interval 73.2 to 82.5
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 52: Change in mTSS ≤ 0	80.6 percentage of participants Interval 76.3 to 84.9	76.1 percentage of participants Interval 69.6 to 82.7	77.1 percentage of participants Interval 70.4 to 83.8	70.6 percentage of participants Interval 65.5 to 75.7
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 Week 52: Change in mTSS ≤ SDC (1.77)	94.2 percentage of participants Interval 91.6 to 96.8	94.9 percentage of participants Interval 91.3 to 98.4	89.2 percentage of participants Interval 84.1 to 94.2	86.7 percentage of participants Interval 82.8 to 90.5

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 Week 12	45.0 score on a scale Standard Deviation 8.42	42.9 score on a scale Standard Deviation 9.71	42.7 score on a scale Standard Deviation 9.90	40.9 score on a scale Standard Deviation 8.10
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 Week 24	46.3 score on a scale Standard Deviation 8.16	44.8 score on a scale Standard Deviation 9.39	44.1 score on a scale Standard Deviation 9.42	43.0 score on a scale Standard Deviation 8.36
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 Week 52	47.4 score on a scale Standard Deviation 8.35	45.6 score on a scale Standard Deviation 9.02	45.9 score on a scale Standard Deviation 9.40	44.5 score on a scale Standard Deviation 8.32
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 Week 4	40.6 score on a scale Standard Deviation 8.04	39.2 score on a scale Standard Deviation 8.86	39.6 score on a scale Standard Deviation 8.46	37.0 score on a scale Standard Deviation 8.13
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 Week 36	46.6 score on a scale Standard Deviation 8.17	45.2 score on a scale Standard Deviation 9.42	45.0 score on a scale Standard Deviation 8.89	44.4 score on a scale Standard Deviation 8.39

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 Baseline	33.9 score on a scale Standard Deviation 7.48	33.7 score on a scale Standard Deviation 8.00	33.6 score on a scale Standard Deviation 7.70	33.3 score on a scale Standard Deviation 7.28
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 Change at Week 4	6.8 score on a scale Standard Deviation 6.86	5.3 score on a scale Standard Deviation 6.90	5.9 score on a scale Standard Deviation 7.53	3.8 score on a scale Standard Deviation 6.38
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 Change at Week 12	11.2 score on a scale Standard Deviation 8.66	9.1 score on a scale Standard Deviation 8.82	8.9 score on a scale Standard Deviation 9.17	7.6 score on a scale Standard Deviation 7.64
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 Change at Week 36	12.4 score on a scale Standard Deviation 9.30	11.7 score on a scale Standard Deviation 8.52	11.2 score on a scale Standard Deviation 8.54	11.3 score on a scale Standard Deviation 9.04
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 Change at Week 52	13.4 score on a scale Standard Deviation 9.62	12.0 score on a scale Standard Deviation 8.47	11.9 score on a scale Standard Deviation 9.22	11.2 score on a scale Standard Deviation 9.49

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 Week 12	49.9 score on a scale Standard Deviation 9.49	49.2 score on a scale Standard Deviation 9.99	48.8 score on a scale Standard Deviation 10.85	48.1 score on a scale Standard Deviation 10.26
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 Week 24	50.1 score on a scale Standard Deviation 9.61	50.1 score on a scale Standard Deviation 10.34	49.2 score on a scale Standard Deviation 10.11	49.4 score on a scale Standard Deviation 10.25
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 Week 4	48.7 score on a scale Standard Deviation 9.73	46.9 score on a scale Standard Deviation 10.42	47.5 score on a scale Standard Deviation 10.46	45.5 score on a scale Standard Deviation 11.38
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 Week 36	51.1 score on a scale Standard Deviation 9.38	50.6 score on a scale Standard Deviation 10.26	49.1 score on a scale Standard Deviation 9.61	49.9 score on a scale Standard Deviation 10.20
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 Week 52	50.9 score on a scale Standard Deviation 9.32	50.0 score on a scale Standard Deviation 10.08	49.7 score on a scale Standard Deviation 10.00	50.2 score on a scale Standard Deviation 9.64

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Change at Week 4	4.1 score on a scale Standard Deviation 9.32	3.6 score on a scale Standard Deviation 8.93	4.5 score on a scale Standard Deviation 9.59	1.9 score on a scale Standard Deviation 9.22
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Change at Week 12	5.3 score on a scale Standard Deviation 10.00	5.7 score on a scale Standard Deviation 10.04	5.5 score on a scale Standard Deviation 10.87	4.5 score on a scale Standard Deviation 10.26
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Change at Week 36	6.5 score on a scale Standard Deviation 10.68	7.3 score on a scale Standard Deviation 11.17	5.4 score on a scale Standard Deviation 11.66	6.2 score on a scale Standard Deviation 10.96
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Change at Week 52	6.2 score on a scale Standard Deviation 10.74	6.8 score on a scale Standard Deviation 11.47	6.1 score on a scale Standard Deviation 11.26	6.5 score on a scale Standard Deviation 11.11
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Baseline	44.6 score on a scale Standard Deviation 10.60	43.2 score on a scale Standard Deviation 11.47	43.1 score on a scale Standard Deviation 11.27	43.5 score on a scale Standard Deviation 11.50
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 Change at Week 24	5.4 score on a scale Standard Deviation 10.45	6.6 score on a scale Standard Deviation 10.89	5.8 score on a scale Standard Deviation 11.26	6.0 score on a scale Standard Deviation 10.95

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 Week 4	35.2 score on a scale Standard Deviation 9.82	34.1 score on a scale Standard Deviation 10.75	34.2 score on a scale Standard Deviation 10.52	31.4 score on a scale Standard Deviation 10.87
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 Week 12	38.1 score on a scale Standard Deviation 10.21	36.6 score on a scale Standard Deviation 11.26	36.9 score on a scale Standard Deviation 11.16	35.3 score on a scale Standard Deviation 10.23
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 Week 52	40.2 score on a scale Standard Deviation 9.36	38.7 score on a scale Standard Deviation 9.88	39.7 score on a scale Standard Deviation 10.96	38.4 score on a scale Standard Deviation 9.91
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 Week 24	39.1 score on a scale Standard Deviation 10.13	38.7 score on a scale Standard Deviation 10.11	37.9 score on a scale Standard Deviation 10.76	37.3 score on a scale Standard Deviation 10.62
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 Week 36	39.8 score on a scale Standard Deviation 9.58	38.9 score on a scale Standard Deviation 10.19	38.8 score on a scale Standard Deviation 10.17	38.1 score on a scale Standard Deviation 9.86

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 Baseline	28.3 score on a scale Standard Deviation 10.93	27.3 score on a scale Standard Deviation 11.92	27.3 score on a scale Standard Deviation 10.90	27.1 score on a scale Standard Deviation 10.72
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 Change at Week 4	7.0 score on a scale Standard Deviation 9.46	6.7 score on a scale Standard Deviation 9.64	6.8 score on a scale Standard Deviation 9.94	4.3 score on a scale Standard Deviation 9.24
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 Change at Week 12	9.8 score on a scale Standard Deviation 11.20	9.2 score on a scale Standard Deviation 11.21	9.4 score on a scale Standard Deviation 10.57	8.1 score on a scale Standard Deviation 10.09
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 Change at Week 36	11.3 score on a scale Standard Deviation 11.21	11.9 score on a scale Standard Deviation 11.53	10.9 score on a scale Standard Deviation 10.81	11.1 score on a scale Standard Deviation 10.91
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 Change at Week 52	11.7 score on a scale Standard Deviation 11.52	11.9 score on a scale Standard Deviation 12.29	11.5 score on a scale Standard Deviation 11.17	11.3 score on a scale Standard Deviation 11.49

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 4 · No Problems	161 Participants	66 Participants	81 Participants	104 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 24 · Extreme Problems	2 Participants	0 Participants	2 Participants	4 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 36 · No Problems	216 Participants	93 Participants	98 Participants	152 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 36 · Slight Problems	96 Participants	60 Participants	46 Participants	135 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 36 · Moderate Problems	48 Participants	30 Participants	27 Participants	51 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 52 · No Problems	217 Participants	91 Participants	93 Participants	156 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 52 · Moderate Problems	28 Participants	29 Participants	21 Participants	54 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 4 · Extreme Problems	1 Participants	3 Participants	1 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 12 · Severe Problems	6 Participants	5 Participants	4 Participants	13 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 36 · Moderate Problems	20 Participants	21 Participants	16 Participants	31 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 52 · Moderate Problems	13 Participants	21 Participants	16 Participants	35 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 12 · No Problems	185 Participants	78 Participants	83 Participants	101 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 12 · Extreme Problems	2 Participants	2 Participants	2 Participants	4 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 24 · Moderate Problems	43 Participants	31 Participants	30 Participants	64 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 36 · Moderate Problems	42 Participants	37 Participants	31 Participants	50 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 36 · Severe Problems	5 Participants	4 Participants	3 Participants	12 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 52 · Slight Problems	106 Participants	62 Participants	48 Participants	125 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 12 · Slight Problems	202 Participants	96 Participants	81 Participants	167 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 52 · Slight Problems	169 Participants	82 Participants	88 Participants	168 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 36 · No Problems	233 Participants	119 Participants	103 Participants	194 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 52 · No Problems	222 Participants	113 Participants	106 Participants	182 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 12 · No Problems	277 Participants	113 Participants	111 Participants	190 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 4 · Slight Problems	149 Participants	68 Participants	56 Participants	135 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 4 · Moderate Problems	82 Participants	50 Participants	38 Participants	116 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 4 · Severe Problems	13 Participants	17 Participants	20 Participants	54 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 4 · Extreme Problems	1 Participants	1 Participants	6 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 12 · No Problems	198 Participants	87 Participants	86 Participants	138 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 12 · Slight Problems	135 Participants	56 Participants	60 Participants	135 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 12 · Moderate Problems	41 Participants	36 Participants	27 Participants	91 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 12 · Severe Problems	12 Participants	17 Participants	14 Participants	20 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 12 · Extreme Problems	4 Participants	0 Participants	5 Participants	4 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 24 · No Problems	208 Participants	92 Participants	95 Participants	152 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 24 · Slight Problems	116 Participants	55 Participants	50 Participants	135 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 24 · Moderate Problems	46 Participants	36 Participants	24 Participants	63 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 24 · Severe Problems	5 Participants	9 Participants	13 Participants	16 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 36 · Severe Problems	5 Participants	5 Participants	8 Participants	16 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 36 · Extreme Problems	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 52 · Slight Problems	92 Participants	50 Participants	47 Participants	108 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 52 · Severe Problems	9 Participants	6 Participants	10 Participants	15 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Mobility: Week 52 · Extreme Problems	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 4 · No Problems	214 Participants	99 Participants	102 Participants	143 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 4 · Slight Problems	142 Participants	63 Participants	50 Participants	141 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 4 · Moderate Problems	42 Participants	28 Participants	38 Participants	96 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 4 · Severe Problems	7 Participants	9 Participants	10 Participants	29 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 12 · Slight Problems	85 Participants	55 Participants	55 Participants	129 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 12 · Moderate Problems	19 Participants	22 Participants	21 Participants	54 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 12 · Extreme Problems	3 Participants	1 Participants	1 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 24 · No Problems	283 Participants	128 Participants	112 Participants	222 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 24 · Slight Problems	73 Participants	42 Participants	52 Participants	95 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 24 · Moderate Problems	16 Participants	20 Participants	17 Participants	46 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 24 · Severe Problems	1 Participants	2 Participants	3 Participants	5 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 24 · Extreme Problems	4 Participants	0 Participants	0 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 36 · No Problems	271 Participants	122 Participants	121 Participants	224 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 36 · Slight Problems	70 Participants	44 Participants	41 Participants	93 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 36 · Severe Problems	3 Participants	1 Participants	1 Participants	5 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 36 · Extreme Problems	1 Participants	0 Participants	1 Participants	3 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 52 · No Problems	268 Participants	117 Participants	117 Participants	208 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 52 · Slight Problems	60 Participants	36 Participants	36 Participants	84 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 52 · Severe Problems	5 Participants	2 Participants	4 Participants	6 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Self-Care: Week 52 · Extreme Problems	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 4 · No Problems	118 Participants	50 Participants	54 Participants	80 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 4 · Slight Problems	180 Participants	86 Participants	81 Participants	153 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 4 · Moderate Problems	90 Participants	47 Participants	49 Participants	122 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 4 · Severe Problems	16 Participants	19 Participants	14 Participants	49 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 4 · Extreme Problems	2 Participants	0 Participants	3 Participants	6 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 12 · Slight Problems	148 Participants	65 Participants	61 Participants	179 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 12 · Moderate Problems	44 Participants	42 Participants	35 Participants	85 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 12 · Severe Problems	11 Participants	9 Participants	11 Participants	19 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 24 · No Problems	188 Participants	92 Participants	83 Participants	142 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 24 · Slight Problems	135 Participants	60 Participants	63 Participants	147 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 24 · Severe Problems	8 Participants	9 Participants	8 Participants	13 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 24 · Extreme Problems	3 Participants	0 Participants	0 Participants	4 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 36 · No Problems	199 Participants	86 Participants	92 Participants	158 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 36 · Slight Problems	119 Participants	61 Participants	51 Participants	134 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 36 · Extreme Problems	0 Participants	0 Participants	3 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 52 · No Problems	203 Participants	84 Participants	92 Participants	147 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 52 · Moderate Problems	31 Participants	22 Participants	27 Participants	50 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 52 · Severe Problems	7 Participants	7 Participants	5 Participants	10 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Usual Activities: Week 52 · Extreme Problems	0 Participants	1 Participants	2 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 4 · No Problems	45 Participants	23 Participants	21 Participants	18 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 4 · Slight Problems	208 Participants	85 Participants	91 Participants	131 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 4 · Moderate Problems	132 Participants	73 Participants	60 Participants	173 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 4 · Severe Problems	21 Participants	19 Participants	26 Participants	78 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 4 · Extreme Problems	0 Participants	2 Participants	3 Participants	10 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 12 · No Problems	93 Participants	35 Participants	38 Participants	41 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 12 · Moderate Problems	83 Participants	47 Participants	53 Participants	143 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 12 · Severe Problems	12 Participants	15 Participants	16 Participants	35 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 12 · Extreme Problems	0 Participants	3 Participants	4 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 24 · No Problems	110 Participants	46 Participants	40 Participants	44 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 24 · Slight Problems	182 Participants	91 Participants	93 Participants	206 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 24 · Moderate Problems	75 Participants	46 Participants	42 Participants	98 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 24 · Severe Problems	9 Participants	9 Participants	7 Participants	22 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 24 · Extreme Problems	1 Participants	0 Participants	2 Participants	0 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 36 · No Problems	102 Participants	43 Participants	39 Participants	57 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 36 · Slight Problems	188 Participants	90 Participants	87 Participants	195 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 36 · Moderate Problems	68 Participants	41 Participants	44 Participants	85 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 36 · Severe Problems	6 Participants	14 Participants	7 Participants	18 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 36 · Extreme Problems	1 Participants	0 Participants	3 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 52 · No Problems	108 Participants	46 Participants	49 Participants	63 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 52 · Moderate Problems	59 Participants	40 Participants	25 Participants	80 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 52 · Severe Problems	11 Participants	8 Participants	9 Participants	22 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Pain/Discomfort: Week 52 · Extreme Problems	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 4 · No Problems	221 Participants	101 Participants	94 Participants	159 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 4 · Slight Problems	126 Participants	58 Participants	64 Participants	148 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 4 · Moderate Problems	53 Participants	33 Participants	35 Participants	73 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 4 · Severe Problems	6 Participants	10 Participants	6 Participants	25 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 4 · Extreme Problems	0 Participants	0 Participants	2 Participants	5 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 12 · No Problems	233 Participants	104 Participants	106 Participants	198 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 12 · Slight Problems	114 Participants	62 Participants	58 Participants	125 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 12 · Moderate Problems	28 Participants	19 Participants	17 Participants	49 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 12 · Severe Problems	14 Participants	9 Participants	10 Participants	15 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 12 · Extreme Problems	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 24 · No Problems	236 Participants	117 Participants	103 Participants	219 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 24 · Slight Problems	97 Participants	47 Participants	64 Participants	93 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 24 · Moderate Problems	32 Participants	25 Participants	11 Participants	42 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 24 · Severe Problems	9 Participants	3 Participants	6 Participants	14 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 24 · Extreme Problems	3 Participants	0 Participants	0 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 36 · Slight Problems	99 Participants	50 Participants	56 Participants	116 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 36 · Moderate Problems	31 Participants	13 Participants	17 Participants	32 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 36 · Severe Problems	2 Participants	5 Participants	3 Participants	12 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 36 · Extreme Problems	0 Participants	1 Participants	1 Participants	2 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 52 · Slight Problems	94 Participants	40 Participants	43 Participants	100 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 52 · Moderate Problems	26 Participants	18 Participants	20 Participants	45 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 52 · Severe Problems	5 Participants	5 Participants	3 Participants	5 Participants
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 Anxiety/Depression: Week 52 · Extreme Problems	0 Participants	0 Participants	2 Participants	2 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Week 4	65 score on a scale Standard Deviation 18.7	61 score on a scale Standard Deviation 21.6	62 score on a scale Standard Deviation 20.0	56 score on a scale Standard Deviation 21.2
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Week 12	69 score on a scale Standard Deviation 21.3	67 score on a scale Standard Deviation 22.9	66 score on a scale Standard Deviation 22.7	64 score on a scale Standard Deviation 20.7
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Week 24	73 score on a scale Standard Deviation 21.0	72 score on a scale Standard Deviation 19.6	68 score on a scale Standard Deviation 22.4	69 score on a scale Standard Deviation 21.3
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Week 36	73 score on a scale Standard Deviation 22.1	71 score on a scale Standard Deviation 21.8	69 score on a scale Standard Deviation 21.1	68 score on a scale Standard Deviation 22.8
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Week 52	75 score on a scale Standard Deviation 21.7	72 score on a scale Standard Deviation 22.1	71 score on a scale Standard Deviation 23.7	71 score on a scale Standard Deviation 21.2

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Baseline	50 score on a scale Standard Deviation 22.0	50 score on a scale Standard Deviation 24.6	51 score on a scale Standard Deviation 22.5	50 score on a scale Standard Deviation 22.1
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Change at Week 4	16 score on a scale Standard Deviation 25.0	10 score on a scale Standard Deviation 24.6	11 score on a scale Standard Deviation 22.4	7 score on a scale Standard Deviation 25.0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Change at Week 12	19 score on a scale Standard Deviation 29.8	17 score on a scale Standard Deviation 28.0	15 score on a scale Standard Deviation 26.1	14 score on a scale Standard Deviation 27.7
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Change at Week 24	24 score on a scale Standard Deviation 28.1	21 score on a scale Standard Deviation 27.7	17 score on a scale Standard Deviation 29.0	19 score on a scale Standard Deviation 28.8
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Change at Week 36	23 score on a scale Standard Deviation 29.7	21 score on a scale Standard Deviation 28.6	18 score on a scale Standard Deviation 28.8	19 score on a scale Standard Deviation 29.8
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 Change at Week 52	26 score on a scale Standard Deviation 31.1	22 score on a scale Standard Deviation 31.5	20 score on a scale Standard Deviation 30.1	22 score on a scale Standard Deviation 30.6

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Week 4	10.1 percentage of work time missed Standard Deviation 23.95	15.4 percentage of work time missed Standard Deviation 30.46	9.2 percentage of work time missed Standard Deviation 21.88	16.0 percentage of work time missed Standard Deviation 30.49
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Week 12	6.7 percentage of work time missed Standard Deviation 19.11	7.3 percentage of work time missed Standard Deviation 18.29	12.6 percentage of work time missed Standard Deviation 24.42	11.3 percentage of work time missed Standard Deviation 25.59
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Week 24	6.4 percentage of work time missed Standard Deviation 19.93	5.7 percentage of work time missed Standard Deviation 13.96	12.4 percentage of work time missed Standard Deviation 23.14	5.1 percentage of work time missed Standard Deviation 14.21
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Week 36	5.5 percentage of work time missed Standard Deviation 15.78	7.0 percentage of work time missed Standard Deviation 17.90	11.5 percentage of work time missed Standard Deviation 25.28	5.6 percentage of work time missed Standard Deviation 16.90
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Week 52	4.6 percentage of work time missed Standard Deviation 14.62	8.5 percentage of work time missed Standard Deviation 20.70	9.8 percentage of work time missed Standard Deviation 22.21	6.4 percentage of work time missed Standard Deviation 19.84

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Week 4	29.6 percentage of impairment while working Standard Deviation 24.21	29.4 percentage of impairment while working Standard Deviation 27.76	33.9 percentage of impairment while working Standard Deviation 24.10	45.3 percentage of impairment while working Standard Deviation 26.04
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Week 12	22.6 percentage of impairment while working Standard Deviation 23.43	23.6 percentage of impairment while working Standard Deviation 24.85	26.0 percentage of impairment while working Standard Deviation 24.78	32.5 percentage of impairment while working Standard Deviation 24.31
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Week 24	17.9 percentage of impairment while working Standard Deviation 18.95	18.1 percentage of impairment while working Standard Deviation 19.40	23.2 percentage of impairment while working Standard Deviation 24.70	23.3 percentage of impairment while working Standard Deviation 21.18
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Week 36	15.5 percentage of impairment while working Standard Deviation 18.38	16.3 percentage of impairment while working Standard Deviation 20.31	20.9 percentage of impairment while working Standard Deviation 24.04	22.7 percentage of impairment while working Standard Deviation 24.10
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Week 52	14.5 percentage of impairment while working Standard Deviation 18.08	19.6 percentage of impairment while working Standard Deviation 22.32	16.5 percentage of impairment while working Standard Deviation 23.08	18.3 percentage of impairment while working Standard Deviation 16.95

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 4	32.8 percentage of overall work productivity Standard Deviation 25.79	32.3 percentage of overall work productivity Standard Deviation 29.18	37.0 percentage of overall work productivity Standard Deviation 25.87	48.6 percentage of overall work productivity Standard Deviation 27.40
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 12	25.1 percentage of overall work productivity Standard Deviation 26.42	26.7 percentage of overall work productivity Standard Deviation 28.11	31.4 percentage of overall work productivity Standard Deviation 28.43	35.5 percentage of overall work productivity Standard Deviation 26.13
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 24	20.2 percentage of overall work productivity Standard Deviation 22.36	22.4 percentage of overall work productivity Standard Deviation 22.92	29.3 percentage of overall work productivity Standard Deviation 28.98	26.2 percentage of overall work productivity Standard Deviation 23.45
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 36	18.8 percentage of overall work productivity Standard Deviation 22.09	20.9 percentage of overall work productivity Standard Deviation 23.34	24.5 percentage of overall work productivity Standard Deviation 28.11	25.0 percentage of overall work productivity Standard Deviation 25.89
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 52	17.2 percentage of overall work productivity Standard Deviation 21.61	22.9 percentage of overall work productivity Standard Deviation 25.21	21.2 percentage of overall work productivity Standard Deviation 27.26	20.7 percentage of overall work productivity Standard Deviation 18.67

SECONDARY outcome

Timeframe: Weeks 4, 12, 24, 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 4	40.4 percentage of activity impairment Standard Deviation 25.52	46.8 percentage of activity impairment Standard Deviation 27.82	45.4 percentage of activity impairment Standard Deviation 25.65	51.6 percentage of activity impairment Standard Deviation 24.73
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 12	30.6 percentage of activity impairment Standard Deviation 25.53	36.1 percentage of activity impairment Standard Deviation 26.77	34.7 percentage of activity impairment Standard Deviation 27.29	41.1 percentage of activity impairment Standard Deviation 24.75
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 24	26.5 percentage of activity impairment Standard Deviation 23.32	29.5 percentage of activity impairment Standard Deviation 26.02	32.3 percentage of activity impairment Standard Deviation 26.92	32.1 percentage of activity impairment Standard Deviation 24.44
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 36	23.5 percentage of activity impairment Standard Deviation 22.54	29.7 percentage of activity impairment Standard Deviation 27.03	29.0 percentage of activity impairment Standard Deviation 26.08	31.8 percentage of activity impairment Standard Deviation 25.55
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Week 52	22.5 percentage of activity impairment Standard Deviation 22.80	28.2 percentage of activity impairment Standard Deviation 26.54	25.6 percentage of activity impairment Standard Deviation 25.19	28.8 percentage of activity impairment Standard Deviation 23.81

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Baseline	12.8 percentage of work time missed Standard Deviation 24.29	20.1 percentage of work time missed Standard Deviation 32.36	13.5 percentage of work time missed Standard Deviation 26.35	15.6 percentage of work time missed Standard Deviation 28.79
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 4	-1.5 percentage of work time missed Standard Deviation 25.68	-3.3 percentage of work time missed Standard Deviation 24.44	-4.0 percentage of work time missed Standard Deviation 21.08	-1.3 percentage of work time missed Standard Deviation 23.73
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 12	-4.9 percentage of work time missed Standard Deviation 25.11	-11.0 percentage of work time missed Standard Deviation 32.65	-2.3 percentage of work time missed Standard Deviation 23.52	-5.2 percentage of work time missed Standard Deviation 29.01
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 24	-4.8 percentage of work time missed Standard Deviation 28.91	-15.5 percentage of work time missed Standard Deviation 34.51	-3.1 percentage of work time missed Standard Deviation 28.77	-10.6 percentage of work time missed Standard Deviation 29.08
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 36	-6.7 percentage of work time missed Standard Deviation 28.20	-16.4 percentage of work time missed Standard Deviation 35.63	-4.1 percentage of work time missed Standard Deviation 26.83	-7.9 percentage of work time missed Standard Deviation 29.99
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 52	-4.8 percentage of work time missed Standard Deviation 23.27	-15.7 percentage of work time missed Standard Deviation 32.72	-2.8 percentage of work time missed Standard Deviation 29.12	-6.7 percentage of work time missed Standard Deviation 31.63

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 12	-25.6 percentage of impairment while working Standard Deviation 27.09	-28.4 percentage of impairment while working Standard Deviation 29.39	-26.0 percentage of impairment while working Standard Deviation 24.70	-20.7 percentage of impairment while working Standard Deviation 27.83
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 24	-27.1 percentage of impairment while working Standard Deviation 26.77	-32.9 percentage of impairment while working Standard Deviation 28.20	-27.9 percentage of impairment while working Standard Deviation 27.06	-28.3 percentage of impairment while working Standard Deviation 29.06
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 36	-29.1 percentage of impairment while working Standard Deviation 24.99	-33.8 percentage of impairment while working Standard Deviation 27.99	-30.3 percentage of impairment while working Standard Deviation 29.38	-28.8 percentage of impairment while working Standard Deviation 31.92
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 52	-32.3 percentage of impairment while working Standard Deviation 26.81	-32.7 percentage of impairment while working Standard Deviation 31.75	-33.3 percentage of impairment while working Standard Deviation 29.25	-31.5 percentage of impairment while working Standard Deviation 28.23
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Baseline	47.3 percentage of impairment while working Standard Deviation 26.32	49.0 percentage of impairment while working Standard Deviation 28.45	52.1 percentage of impairment while working Standard Deviation 25.81	53.6 percentage of impairment while working Standard Deviation 27.12
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 Change at Week 4	-17.8 percentage of impairment while working Standard Deviation 25.34	-19.8 percentage of impairment while working Standard Deviation 27.49	-18.3 percentage of impairment while working Standard Deviation 28.58	-7.4 percentage of impairment while working Standard Deviation 20.55

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Baseline	50.8 percentage of overall work productivity Standard Deviation 27.28	51.6 percentage of overall work productivity Standard Deviation 30.10	54.4 percentage of overall work productivity Standard Deviation 25.60	56.1 percentage of overall work productivity Standard Deviation 28.00
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 4	-17.6 percentage of overall work productivity Standard Deviation 26.21	-19.0 percentage of overall work productivity Standard Deviation 29.43	-17.6 percentage of overall work productivity Standard Deviation 28.69	-6.4 percentage of overall work productivity Standard Deviation 22.27
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 12	-26.3 percentage of overall work productivity Standard Deviation 28.85	-27.5 percentage of overall work productivity Standard Deviation 30.53	-23.5 percentage of overall work productivity Standard Deviation 26.01	-20.1 percentage of overall work productivity Standard Deviation 28.63
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 24	-28.5 percentage of overall work productivity Standard Deviation 27.71	-31.3 percentage of overall work productivity Standard Deviation 30.04	-24.7 percentage of overall work productivity Standard Deviation 29.61	-27.9 percentage of overall work productivity Standard Deviation 29.31
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 36	-29.3 percentage of overall work productivity Standard Deviation 26.76	-33.1 percentage of overall work productivity Standard Deviation 31.56	-29.1 percentage of overall work productivity Standard Deviation 31.79	-29.2 percentage of overall work productivity Standard Deviation 32.72
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 52	-33.0 percentage of overall work productivity Standard Deviation 28.74	-33.5 percentage of overall work productivity Standard Deviation 32.34	-30.6 percentage of overall work productivity Standard Deviation 31.24	-30.8 percentage of overall work productivity Standard Deviation 28.76

SECONDARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg + MTX n=416 Participants Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 Participants Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 Participants Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 Participants Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 4	-19.9 percentage of activity impairment Standard Deviation 24.07	-15.8 percentage of activity impairment Standard Deviation 23.90	-17.8 percentage of activity impairment Standard Deviation 27.11	-12.4 percentage of activity impairment Standard Deviation 23.80
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 24	-33.1 percentage of activity impairment Standard Deviation 26.84	-33.2 percentage of activity impairment Standard Deviation 26.97	-31.2 percentage of activity impairment Standard Deviation 28.01	-31.5 percentage of activity impairment Standard Deviation 27.80
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 36	-35.6 percentage of activity impairment Standard Deviation 26.52	-33.8 percentage of activity impairment Standard Deviation 26.48	-34.1 percentage of activity impairment Standard Deviation 28.26	-32.1 percentage of activity impairment Standard Deviation 28.47
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Baseline	60.2 percentage of activity impairment Standard Deviation 23.36	62.8 percentage of activity impairment Standard Deviation 23.10	63.3 percentage of activity impairment Standard Deviation 24.37	64.0 percentage of activity impairment Standard Deviation 22.59
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 12	-29.4 percentage of activity impairment Standard Deviation 27.15	-26.4 percentage of activity impairment Standard Deviation 26.19	-28.7 percentage of activity impairment Standard Deviation 27.80	-22.7 percentage of activity impairment Standard Deviation 25.32
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 Change at Week 52	-36.7 percentage of activity impairment Standard Deviation 27.11	-35.4 percentage of activity impairment Standard Deviation 28.32	-36.7 percentage of activity impairment Standard Deviation 28.37	-34.2 percentage of activity impairment Standard Deviation 28.83

Adverse Events

Filgotinib 200 mg + MTX

Serious events: 26 serious events

Other events: 179 other events

Deaths: 3 deaths

Filgotinib 100 mg + MTX

Serious events: 13 serious events

Other events: 88 other events

Deaths: 1 deaths

Filgotinib 200 mg Monotherapy

Serious events: 17 serious events

Other events: 78 other events

Deaths: 0 deaths

MTX Monotherapy

Serious events: 28 serious events

Other events: 164 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Filgotinib 200 mg + MTX n=416 participants at risk Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + methotrexate (MTX) up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 100 mg + MTX n=207 participants at risk Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.	Filgotinib 200 mg Monotherapy n=210 participants at risk Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.	MTX Monotherapy n=416 participants at risk Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Gastrointestinal disorders Diarrhoea	4.1% 17/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.8% 12/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.9% 6/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.0% 21/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	12.3% 51/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	16.9% 35/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 15/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	12.0% 50/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	2.9% 12/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.3% 11/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 4/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.6% 15/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	5.0% 21/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.2% 17/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.1% 17/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.0% 25/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	10.1% 42/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.3% 9/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.7% 14/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	8.2% 34/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Urinary tract infection	4.6% 19/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.3% 13/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.2% 11/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.6% 11/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	5.5% 23/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.9% 6/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.4% 3/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.6% 11/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Headache	5.5% 23/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.9% 8/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.8% 8/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.0% 25/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	4.1% 17/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.2% 15/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 4/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.8% 20/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	5.0% 21/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.8% 10/207 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.1% 15/210 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.4% 14/416 • First dose date up to last dose date (Maximum: 56 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER