Trial Outcomes & Findings for Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (NCT NCT02889796)

Last Updated: 2021-06-09

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)participant'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

1759 participants

Primary outcome timeframe

Week 12

Results posted on

2021-06-09

Participant Flow

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

2582 participants were screened.

Participant milestones

Participant milestones
Measure	Filgotinib 200 mg Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Adalimumab Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo to Filgotinib 200 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo Never Received Filgotinib Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.
Overall Study STARTED	477	480	325	190	191	96
Overall Study COMPLETED	424	422	281	181	185	24
Overall Study NOT COMPLETED	53	58	44	9	6	72

Reasons for withdrawal

Reasons for withdrawal
Measure	Filgotinib 200 mg Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Adalimumab Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo to Filgotinib 200 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo Never Received Filgotinib Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks.
Overall Study Withdrew Consent	18	29	20	1	2	35
Overall Study Investigator's Discretion	10	9	10	3	0	15
Overall Study Adverse Event	17	8	8	4	1	7
Overall Study Lost to Follow-up	5	7	2	0	2	6
Overall Study Protocol Violation	0	1	3	0	0	4
Overall Study Non-compliance With Study Drug	0	2	0	0	1	2
Overall Study Death	1	1	0	1	0	1
Overall Study Pregnancy	0	1	1	0	0	0
Overall Study Randomized but not Dosed	2	0	0	0	0	2

Baseline Characteristics

Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Adalimumab n=325 Participants Participants were administered PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Total n=1755 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 12.8 • n=93 Participants	53 years STANDARD_DEVIATION 12.6 • n=4 Participants	53 years STANDARD_DEVIATION 12.9 • n=27 Participants	53 years STANDARD_DEVIATION 12.8 • n=483 Participants	53 years STANDARD_DEVIATION 12.7 • n=36 Participants
Sex: Female, Male Female	379 Participants n=93 Participants	399 Participants n=4 Participants	266 Participants n=27 Participants	391 Participants n=483 Participants	1435 Participants n=36 Participants
Sex: Female, Male Male	96 Participants n=93 Participants	81 Participants n=4 Participants	59 Participants n=27 Participants	84 Participants n=483 Participants	320 Participants n=36 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	27 Participants n=93 Participants	27 Participants n=4 Participants	20 Participants n=27 Participants	29 Participants n=483 Participants	103 Participants n=36 Participants
Race/Ethnicity, Customized Race · Asian: Japanese	40 Participants n=93 Participants	41 Participants n=4 Participants	28 Participants n=27 Participants	38 Participants n=483 Participants	147 Participants n=36 Participants
Race/Ethnicity, Customized Race · Asian: Chinese/Taiwanese/Hong Kong Chinese	13 Participants n=93 Participants	12 Participants n=4 Participants	8 Participants n=27 Participants	18 Participants n=483 Participants	51 Participants n=36 Participants
Race/Ethnicity, Customized Race · Asian: Korean	13 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	34 Participants n=36 Participants
Race/Ethnicity, Customized Race · Asian: Other	56 Participants n=93 Participants	52 Participants n=4 Participants	25 Participants n=27 Participants	46 Participants n=483 Participants	179 Participants n=36 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=93 Participants	7 Participants n=4 Participants	10 Participants n=27 Participants	12 Participants n=483 Participants	35 Participants n=36 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	3 Participants n=36 Participants
Race/Ethnicity, Customized Race · White	312 Participants n=93 Participants	324 Participants n=4 Participants	229 Participants n=27 Participants	319 Participants n=483 Participants	1184 Participants n=36 Participants
Race/Ethnicity, Customized Race · Other	7 Participants n=93 Participants	6 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	17 Participants n=36 Participants
Race/Ethnicity, Customized Race · Not Permitted	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	67 Participants n=93 Participants	71 Participants n=4 Participants	54 Participants n=27 Participants	70 Participants n=483 Participants	262 Participants n=36 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	404 Participants n=93 Participants	399 Participants n=4 Participants	268 Participants n=27 Participants	400 Participants n=483 Participants	1471 Participants n=36 Participants
Race/Ethnicity, Customized Ethnicity · Not Permitted	4 Participants n=93 Participants	10 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants	22 Participants n=36 Participants
Region of Enrollment United States	47 Participants n=93 Participants	55 Participants n=4 Participants	37 Participants n=27 Participants	60 Participants n=483 Participants	199 Participants n=36 Participants
Region of Enrollment South Africa	12 Participants n=93 Participants	11 Participants n=4 Participants	3 Participants n=27 Participants	8 Participants n=483 Participants	34 Participants n=36 Participants
Region of Enrollment South Korea	12 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	33 Participants n=36 Participants
Region of Enrollment Spain	14 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants	7 Participants n=483 Participants	30 Participants n=36 Participants
Region of Enrollment Germany	5 Participants n=93 Participants	6 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	20 Participants n=36 Participants
Region of Enrollment New Zealand	5 Participants n=93 Participants	5 Participants n=4 Participants	3 Participants n=27 Participants	5 Participants n=483 Participants	18 Participants n=36 Participants
Region of Enrollment United Kingdom	1 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	6 Participants n=483 Participants	13 Participants n=36 Participants
Region of Enrollment Canada	4 Participants n=93 Participants	4 Participants n=4 Participants	3 Participants n=27 Participants	1 Participants n=483 Participants	12 Participants n=36 Participants
Region of Enrollment Israel	4 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	11 Participants n=36 Participants
Region of Enrollment Belgium	2 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	1 Participants n=483 Participants	10 Participants n=36 Participants
Region of Enrollment Italy	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants	1 Participants n=483 Participants	6 Participants n=36 Participants
Region of Enrollment Netherlands	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants
Region of Enrollment Australia	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment Ireland	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Region of Enrollment Poland	78 Participants n=93 Participants	82 Participants n=4 Participants	64 Participants n=27 Participants	74 Participants n=483 Participants	298 Participants n=36 Participants
Region of Enrollment Ukraine	66 Participants n=93 Participants	73 Participants n=4 Participants	41 Participants n=27 Participants	55 Participants n=483 Participants	235 Participants n=36 Participants
Region of Enrollment India	40 Participants n=93 Participants	39 Participants n=4 Participants	19 Participants n=27 Participants	39 Participants n=483 Participants	137 Participants n=36 Participants
Region of Enrollment Russia	34 Participants n=93 Participants	32 Participants n=4 Participants	22 Participants n=27 Participants	30 Participants n=483 Participants	118 Participants n=36 Participants
Region of Enrollment Hungary	12 Participants n=93 Participants	12 Participants n=4 Participants	5 Participants n=27 Participants	17 Participants n=483 Participants	46 Participants n=36 Participants
Region of Enrollment Bulgaria	7 Participants n=93 Participants	7 Participants n=4 Participants	6 Participants n=27 Participants	14 Participants n=483 Participants	34 Participants n=36 Participants
Region of Enrollment Czechia	7 Participants n=93 Participants	7 Participants n=4 Participants	7 Participants n=27 Participants	13 Participants n=483 Participants	34 Participants n=36 Participants
Region of Enrollment Romania	12 Participants n=93 Participants	6 Participants n=4 Participants	2 Participants n=27 Participants	11 Participants n=483 Participants	31 Participants n=36 Participants
Region of Enrollment Serbia	1 Participants n=93 Participants	7 Participants n=4 Participants	8 Participants n=27 Participants	5 Participants n=483 Participants	21 Participants n=36 Participants
Region of Enrollment Slovakia	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	3 Participants n=483 Participants	8 Participants n=36 Participants
Region of Enrollment Mexico	33 Participants n=93 Participants	33 Participants n=4 Participants	25 Participants n=27 Participants	34 Participants n=483 Participants	125 Participants n=36 Participants
Region of Enrollment Argentina	15 Participants n=93 Participants	17 Participants n=4 Participants	10 Participants n=27 Participants	15 Participants n=483 Participants	57 Participants n=36 Participants
Region of Enrollment Taiwan	12 Participants n=93 Participants	9 Participants n=4 Participants	7 Participants n=27 Participants	16 Participants n=483 Participants	44 Participants n=36 Participants
Region of Enrollment Thailand	7 Participants n=93 Participants	6 Participants n=4 Participants	6 Participants n=27 Participants	4 Participants n=483 Participants	23 Participants n=36 Participants
Region of Enrollment Hong Kong	1 Participants n=93 Participants	3 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	7 Participants n=36 Participants
Region of Enrollment Japan	40 Participants n=93 Participants	41 Participants n=4 Participants	28 Participants n=27 Participants	38 Participants n=483 Participants	147 Participants n=36 Participants

PRIMARY outcome

Timeframe: Week 12

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12	76.6 percentage of participants Interval 72.7 to 80.5	69.8 percentage of participants Interval 65.6 to 74.0	70.5 percentage of participants Interval 65.3 to 75.6	49.9 percentage of participants Interval 45.3 to 54.5	—

SECONDARY outcome

Timeframe: Baseline; Week 12

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). 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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 Baseline	1.59 score on a scale Standard Deviation 0.611	1.55 score on a scale Standard Deviation 0.625	1.59 score on a scale Standard Deviation 0.600	1.63 score on a scale Standard Deviation 0.613	—
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12 Change from Baseline at Week 12	-0.69 score on a scale Standard Deviation 0.613	-0.56 score on a scale Standard Deviation 0.564	-0.61 score on a scale Standard Deviation 0.560	-0.42 score on a scale Standard Deviation 0.544	—

SECONDARY outcome

Timeframe: Week 12

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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12	34.1 percentage of participants Interval 29.7 to 38.5	23.8 percentage of participants Interval 19.8 to 27.7	23.7 percentage of participants Interval 18.9 to 28.5	9.3 percentage of participants Interval 6.6 to 12.0	—

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, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces).

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=467 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=471 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=466 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 Baseline	32.47 score on a scale Standard Deviation 47.939	36.70 score on a scale Standard Deviation 53.065	34.82 score on a scale Standard Deviation 55.013	31.60 score on a scale Standard Deviation 53.217	—
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 Change from Baseline at Week 24	0.13 score on a scale Standard Deviation 0.937	0.17 score on a scale Standard Deviation 0.905	0.16 score on a scale Standard Deviation 0.948	0.37 score on a scale Standard Deviation 1.417	—

SECONDARY outcome

Timeframe: Week 12

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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12	49.7 percentage of participants Interval 45.1 to 54.3	38.8 percentage of participants Interval 34.3 to 43.2	43.4 percentage of participants Interval 37.8 to 48.9	23.4 percentage of participants Interval 19.5 to 27.3	—

SECONDARY outcome

Timeframe: Baseline; Week 12

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 n=473 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=479 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=323 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=474 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 Baseline	33.4 score on a scale Standard Deviation 7.17	33.6 score on a scale Standard Deviation 7.75	32.8 score on a scale Standard Deviation 7.74	32.9 score on a scale Standard Deviation 7.11	—
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12 Change from Baseline at Week 12	9.2 score on a scale Standard Deviation 8.10	8.5 score on a scale Standard Deviation 7.72	8.4 score on a scale Standard Deviation 7.89	5.8 score on a scale Standard Deviation 7.10	—

SECONDARY outcome

Timeframe: Baseline; Week 12

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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=469 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 Baseline	27.6 score on a scale Standard Deviation 10.68	27.8 score on a scale Standard Deviation 10.60	27.2 score on a scale Standard Deviation 10.20	26.9 score on a scale Standard Deviation 10.34	—
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12 Change from Baseline at Week 12	9.2 score on a scale Standard Deviation 9.82	9.1 score on a scale Standard Deviation 10.15	8.8 score on a scale Standard Deviation 9.19	6.8 score on a scale Standard Deviation 9.89	—

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 Week 2	9.1 percentage of participants Interval 6.4 to 11.7	5.8 percentage of participants Interval 3.6 to 8.0	6.8 percentage of participants Interval 3.9 to 9.7	1.1 percentage of participants Interval 0.0 to 2.1	—
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 Week 4	22.3 percentage of participants Interval 18.5 to 26.2	12.9 percentage of participants Interval 9.8 to 16.0	17.2 percentage of participants Interval 13.0 to 21.5	5.9 percentage of participants Interval 3.7 to 8.1	—
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 Week 12	47.2 percentage of participants Interval 42.6 to 51.8	36.5 percentage of participants Interval 32.0 to 40.9	35.1 percentage of participants Interval 29.7 to 40.4	19.8 percentage of participants Interval 16.1 to 23.5	—
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24 Week 24	57.9 percentage of participants Interval 53.3 to 62.4	52.7 percentage of participants Interval 48.1 to 57.3	52.3 percentage of participants Interval 46.7 to 57.9	33.3 percentage of participants Interval 28.9 to 37.6	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 Week 36	63.2 percentage of participants Interval 58.7 to 67.6	57.7 percentage of participants Interval 53.2 to 62.2	57.5 percentage of participants Interval 52.0 to 63.1	67.9 percentage of participants Interval 61.0 to 74.8	63.4 percentage of participants Interval 56.3 to 70.4
Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52 Week 52	64.2 percentage of participants Interval 59.8 to 68.6	60.6 percentage of participants Interval 56.2 to 65.1	62.2 percentage of participants Interval 56.7 to 67.6	68.4 percentage of participants Interval 61.5 to 75.3	66.0 percentage of participants Interval 59.0 to 72.9

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 Week 12	26.1 percentage of participants Interval 22.1 to 30.2	18.5 percentage of participants Interval 15.0 to 22.1	14.2 percentage of participants Interval 10.2 to 18.1	6.7 percentage of participants Interval 4.4 to 9.1	—
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 Week 24	36.2 percentage of participants Interval 31.8 to 40.6	29.6 percentage of participants Interval 25.4 to 33.8	29.5 percentage of participants Interval 24.4 to 34.7	14.9 percentage of participants Interval 11.6 to 18.3	—
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 Week 2	2.7 percentage of participants Interval 1.2 to 4.3	1.3 percentage of participants Interval 0.2 to 2.3	0.9 percentage of participants Interval 0.0 to 2.1	0.4 percentage of participants Interval 0.0 to 1.1	—
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24 Week 4	9.1 percentage of participants Interval 6.4 to 11.7	3.3 percentage of participants Interval 1.6 to 5.0	3.7 percentage of participants Interval 1.5 to 5.9	1.5 percentage of participants Interval 0.3 to 2.7	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 Week 52	44.4 percentage of participants Interval 39.8 to 49.0	39.0 percentage of participants Interval 34.5 to 43.4	41.2 percentage of participants Interval 35.7 to 46.7	48.4 percentage of participants Interval 41.1 to 55.8	37.7 percentage of participants Interval 30.6 to 44.8
Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52 Week 36	40.2 percentage of participants Interval 35.7 to 44.7	35.4 percentage of participants Interval 31.0 to 39.8	32.9 percentage of participants Interval 27.7 to 38.2	44.7 percentage of participants Interval 37.4 to 52.1	34.6 percentage of participants Interval 27.5 to 41.6

SECONDARY outcome

Timeframe: Weeks 2, 4, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 Week 2	37.3 percentage of participants Interval 32.8 to 41.7	27.5 percentage of participants Interval 23.4 to 31.6	33.5 percentage of participants Interval 28.3 to 38.8	14.9 percentage of participants Interval 11.6 to 18.3	—
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 Week 4	51.6 percentage of participants Interval 47.0 to 56.2	45.6 percentage of participants Interval 41.1 to 50.2	47.1 percentage of participants Interval 41.5 to 52.7	31.8 percentage of participants Interval 27.5 to 36.1	—
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24 Week 24	78.1 percentage of participants Interval 74.3 to 81.9	77.7 percentage of participants Interval 73.9 to 81.5	74.5 percentage of participants Interval 69.6 to 79.4	59.2 percentage of participants Interval 54.6 to 63.7	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 Week 36	82.9 percentage of participants Interval 79.5 to 86.4	79.2 percentage of participants Interval 75.4 to 82.9	76.3 percentage of participants Interval 71.5 to 81.1	90.5 percentage of participants Interval 86.1 to 95.0	86.9 percentage of participants Interval 81.9 to 92.0
Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52 Week 52	82.9 percentage of participants Interval 79.5 to 86.4	79.6 percentage of participants Interval 75.9 to 83.3	77.8 percentage of participants Interval 73.2 to 82.5	86.3 percentage of participants Interval 81.2 to 91.5	85.9 percentage of participants Interval 80.7 to 91.1

SECONDARY outcome

Timeframe: Baseline; Weeks 2, 4, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 Change from Baseline at Week 4	-0.43 score on a scale Standard Deviation 0.493	-0.33 score on a scale Standard Deviation 0.454	-0.40 score on a scale Standard Deviation 0.460	-0.26 score on a scale Standard Deviation 0.431	—
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 Baseline	1.59 score on a scale Standard Deviation 0.611	1.55 score on a scale Standard Deviation 0.625	1.59 score on a scale Standard Deviation 0.600	1.63 score on a scale Standard Deviation 0.613	—
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 Change from Baseline at Week 2	-0.30 score on a scale Standard Deviation 0.443	-0.22 score on a scale Standard Deviation 0.406	-0.29 score on a scale Standard Deviation 0.440	-0.15 score on a scale Standard Deviation 0.357	—
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24 Change from Baseline at Week 24	-0.82 score on a scale Standard Deviation 0.632	-0.75 score on a scale Standard Deviation 0.597	-0.78 score on a scale Standard Deviation 0.632	-0.62 score on a scale Standard Deviation 0.598	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 Baseline	1.59 score on a scale Standard Deviation 0.611	1.55 score on a scale Standard Deviation 0.625	1.59 score on a scale Standard Deviation 0.600	1.68 score on a scale Standard Deviation 0.578	1.58 score on a scale Standard Deviation 0.603
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 Change from Baseline at Week 36	-0.88 score on a scale Standard Deviation 0.633	-0.80 score on a scale Standard Deviation 0.611	-0.81 score on a scale Standard Deviation 0.634	-0.96 score on a scale Standard Deviation 0.637	-0.69 score on a scale Standard Deviation 0.610
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52 Change from Baseline at Week 52	-0.93 score on a scale Standard Deviation 0.649	-0.85 score on a scale Standard Deviation 0.621	-0.85 score on a scale Standard Deviation 0.647	-0.99 score on a scale Standard Deviation 0.644	-0.73 score on a scale Standard Deviation 0.650

SECONDARY outcome

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

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-11 tender joint count Standard Deviation 11.1	-10 tender joint count Standard Deviation 10.3	-9 tender joint count Standard Deviation 9.2	-8 tender joint count Standard Deviation 10.5	—
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-17 tender joint count Standard Deviation 11.1	-15 tender joint count Standard Deviation 10.7	-15 tender joint count Standard Deviation 9.9	-13 tender joint count Standard Deviation 11.6	—
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 Baseline	25 tender joint count Standard Deviation 13.5	25 tender joint count Standard Deviation 13.4	24 tender joint count Standard Deviation 13.2	24 tender joint count Standard Deviation 13.5	—
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-8 tender joint count Standard Deviation 10.1	-7 tender joint count Standard Deviation 9.3	-7 tender joint count Standard Deviation 8.8	-5 tender joint count Standard Deviation 9.0	—
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-20 tender joint count Standard Deviation 12.1	-19 tender joint count Standard Deviation 10.9	-18 tender joint count Standard Deviation 11.1	-17 tender joint count Standard Deviation 11.7	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 Baseline	25 tender joint count Standard Deviation 13.5	25 tender joint count Standard Deviation 13.4	24 tender joint count Standard Deviation 13.2	25 tender joint count Standard Deviation 12.8	24 tender joint count Standard Deviation 12.9
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 Change from Baseline at Week 36	-21 tender joint count Standard Deviation 11.9	-20 tender joint count Standard Deviation 11.2	-19 tender joint count Standard Deviation 11.0	-21 tender joint count Standard Deviation 11.4	-19 tender joint count Standard Deviation 11.5
Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52 Change from Baseline at Week 52	-21 tender joint count Standard Deviation 12.2	-21 tender joint count Standard Deviation 11.4	-20 tender joint count Standard Deviation 11.4	-21 tender joint count Standard Deviation 11.9	-20 tender joint count Standard Deviation 11.2

SECONDARY outcome

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

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" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 Baseline	15 swollen joint count Standard Deviation 8.5	15 swollen joint count Standard Deviation 8.5	16 swollen joint count Standard Deviation 8.4	16 swollen joint count Standard Deviation 8.5	—
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-6 swollen joint count Standard Deviation 6.7	-5 swollen joint count Standard Deviation 6.8	-6 swollen joint count Standard Deviation 5.8	-5 swollen joint count Standard Deviation 6.9	—
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-8 swollen joint count Standard Deviation 7.1	-8 swollen joint count Standard Deviation 7.8	-7 swollen joint count Standard Deviation 6.6	-6 swollen joint count Standard Deviation 7.8	—
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-11 swollen joint count Standard Deviation 7.5	-11 swollen joint count Standard Deviation 8.1	-11 swollen joint count Standard Deviation 7.1	-10 swollen joint count Standard Deviation 8.4	—
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-13 swollen joint count Standard Deviation 7.8	-13 swollen joint count Standard Deviation 7.4	-13 swollen joint count Standard Deviation 6.9	-12 swollen joint count Standard Deviation 7.7	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 Baseline	15 swollen joint count Standard Deviation 8.5	15 swollen joint count Standard Deviation 8.5	16 swollen joint count Standard Deviation 8.4	16 swollen joint count Standard Deviation 8.2	15 swollen joint count Standard Deviation 7.9
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 Change from Baseline at Week 36	-14 swollen joint count Standard Deviation 7.8	-13 swollen joint count Standard Deviation 7.6	-14 swollen joint count Standard Deviation 7.1	-14 swollen joint count Standard Deviation 7.3	-13 swollen joint count Standard Deviation 7.2
Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52 Change from Baseline at Week 52	-14 swollen joint count Standard Deviation 8.1	-13 swollen joint count Standard Deviation 7.6	-14 swollen joint count Standard Deviation 7.5	-14 swollen joint count Standard Deviation 7.8	-13 swollen joint count Standard Deviation 7.4

SECONDARY outcome

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

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-16 score on a scale Standard Deviation 20.1	-11 score on a scale Standard Deviation 18.4	-13 score on a scale Standard Deviation 18.1	-8 score on a scale Standard Deviation 17.2	—
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-22 score on a scale Standard Deviation 21.5	-16 score on a scale Standard Deviation 20.8	-19 score on a scale Standard Deviation 20.8	-13 score on a scale Standard Deviation 20.2	—
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 Baseline	67 score on a scale Standard Deviation 19.2	65 score on a scale Standard Deviation 19.7	67 score on a scale Standard Deviation 19.1	68 score on a scale Standard Deviation 18.7	—
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-33 score on a scale Standard Deviation 24.8	-28 score on a scale Standard Deviation 24.7	-28 score on a scale Standard Deviation 23.2	-21 score on a scale Standard Deviation 24.8	—
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-39 score on a scale Standard Deviation 25.8	-36 score on a scale Standard Deviation 24.9	-36 score on a scale Standard Deviation 24.9	-31 score on a scale Standard Deviation 26.9	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 Baseline	67 score on a scale Standard Deviation 19.2	65 score on a scale Standard Deviation 19.7	67 score on a scale Standard Deviation 19.1	70 score on a scale Standard Deviation 17.8	66 score on a scale Standard Deviation 18.7
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 Change from Baseline at Week 36	-42 score on a scale Standard Deviation 24.2	-39 score on a scale Standard Deviation 25.3	-39 score on a scale Standard Deviation 25.2	-45 score on a scale Standard Deviation 24.7	-38 score on a scale Standard Deviation 25.5
Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52 Change from Baseline at Week 52	-44 score on a scale Standard Deviation 24.4	-41 score on a scale Standard Deviation 25.4	-42 score on a scale Standard Deviation 25.7	-45 score on a scale Standard Deviation 27.6	-41 score on a scale Standard Deviation 25.3

SECONDARY outcome

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

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-20 score on a scale Standard Deviation 19.3	-18 score on a scale Standard Deviation 18.5	-19 score on a scale Standard Deviation 17.9	-13 score on a scale Standard Deviation 17.8	—
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-28 score on a scale Standard Deviation 21.2	-26 score on a scale Standard Deviation 19.7	-26 score on a scale Standard Deviation 19.6	-20 score on a scale Standard Deviation 19.6	—
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 Baseline	66 score on a scale Standard Deviation 16.0	65 score on a scale Standard Deviation 16.5	67 score on a scale Standard Deviation 15.5	66 score on a scale Standard Deviation 16.2	—
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-41 score on a scale Standard Deviation 20.2	-39 score on a scale Standard Deviation 20.3	-39 score on a scale Standard Deviation 20.4	-34 score on a scale Standard Deviation 22.4	—
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-48 score on a scale Standard Deviation 19.2	-46 score on a scale Standard Deviation 19.6	-47 score on a scale Standard Deviation 19.4	-42 score on a scale Standard Deviation 20.4	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 Change from Baseline at Week 36	-51 score on a scale Standard Deviation 19.0	-49 score on a scale Standard Deviation 19.8	-50 score on a scale Standard Deviation 18.6	-53 score on a scale Standard Deviation 19.5	-47 score on a scale Standard Deviation 20.0
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 Baseline	66 score on a scale Standard Deviation 16.0	65 score on a scale Standard Deviation 16.5	67 score on a scale Standard Deviation 15.5	68 score on a scale Standard Deviation 15.6	64 score on a scale Standard Deviation 16.3
Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52 Change from Baseline at Week 52	-53 score on a scale Standard Deviation 18.2	-50 score on a scale Standard Deviation 19.2	-52 score on a scale Standard Deviation 18.9	-54 score on a scale Standard Deviation 19.7	-50 score on a scale Standard Deviation 19.3

SECONDARY outcome

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

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 Baseline	65 score on a scale Standard Deviation 20.4	64 score on a scale Standard Deviation 20.1	64 score on a scale Standard Deviation 19.5	66 score on a scale Standard Deviation 19.0	—
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-16 score on a scale Standard Deviation 21.0	-12 score on a scale Standard Deviation 18.7	-13 score on a scale Standard Deviation 20.4	-7 score on a scale Standard Deviation 18.2	—
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-21 score on a scale Standard Deviation 23.7	-18 score on a scale Standard Deviation 20.9	-18 score on a scale Standard Deviation 21.9	-12 score on a scale Standard Deviation 20.8	—
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-31 score on a scale Standard Deviation 26.9	-29 score on a scale Standard Deviation 25.3	-27 score on a scale Standard Deviation 23.6	-21 score on a scale Standard Deviation 26.0	—
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-38 score on a scale Standard Deviation 27.0	-37 score on a scale Standard Deviation 25.6	-35 score on a scale Standard Deviation 24.2	-30 score on a scale Standard Deviation 27.0	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 Baseline	65 score on a scale Standard Deviation 20.4	64 score on a scale Standard Deviation 20.1	64 score on a scale Standard Deviation 19.5	68 score on a scale Standard Deviation 18.0	65 score on a scale Standard Deviation 19.2
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 Change from Baseline at Week 36	-40 score on a scale Standard Deviation 26.3	-38 score on a scale Standard Deviation 26.2	-37 score on a scale Standard Deviation 25.5	-44 score on a scale Standard Deviation 24.9	-39 score on a scale Standard Deviation 25.9
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52 Change from Baseline at Week 52	-43 score on a scale Standard Deviation 26.2	-41 score on a scale Standard Deviation 25.9	-41 score on a scale Standard Deviation 25.6	-45 score on a scale Standard Deviation 26.6	-41 score on a scale Standard Deviation 25.6

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-10.85 mg/L Standard Deviation 20.154	-7.67 mg/L Standard Deviation 17.888	-8.03 mg/L Standard Deviation 15.594	-0.07 mg/L Standard Deviation 17.244	—
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 Baseline	16.13 mg/L Standard Deviation 21.005	16.74 mg/L Standard Deviation 22.982	14.56 mg/L Standard Deviation 18.003	16.25 mg/L Standard Deviation 24.051	—
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-9.99 mg/L Standard Deviation 21.146	-8.44 mg/L Standard Deviation 20.201	-7.17 mg/L Standard Deviation 16.896	-1.12 mg/L Standard Deviation 19.940	—
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-11.00 mg/L Standard Deviation 18.659	-9.55 mg/L Standard Deviation 21.330	-7.85 mg/L Standard Deviation 20.632	-3.26 mg/L Standard Deviation 22.711	—
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-11.84 mg/L Standard Deviation 20.693	-10.54 mg/L Standard Deviation 22.215	-6.17 mg/L Standard Deviation 24.224	-4.00 mg/L Standard Deviation 19.614	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 Baseline	16.13 mg/L Standard Deviation 21.005	16.74 mg/L Standard Deviation 22.982	14.56 mg/L Standard Deviation 18.003	16.54 mg/L Standard Deviation 24.782	15.76 mg/L Standard Deviation 21.871
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 Change from Baseline at Week 36	-11.51 mg/L Standard Deviation 21.990	-10.72 mg/L Standard Deviation 22.569	-8.73 mg/L Standard Deviation 18.214	-12.12 mg/L Standard Deviation 23.151	-8.50 mg/L Standard Deviation 19.749
Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52 Change from Baseline at Week 52	-12.19 mg/L Standard Deviation 20.773	-11.27 mg/L Standard Deviation 23.129	-9.60 mg/L Standard Deviation 16.511	-11.43 mg/L Standard Deviation 20.873	-8.74 mg/L Standard Deviation 19.921

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, and 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 (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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 Week 2	52.5 percentage of participants Interval 47.8 to 57.2	46.7 percentage of participants Interval 42.0 to 51.3	51.9 percentage of participants Interval 46.2 to 57.6	40.2 percentage of participants Interval 35.6 to 44.7	—
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 Week 12	78.9 percentage of participants Interval 75.0 to 82.7	71.5 percentage of participants Interval 67.3 to 75.7	72.8 percentage of participants Interval 67.6 to 77.9	57.9 percentage of participants Interval 53.3 to 62.5	—
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 Week 4	66.2 percentage of participants Interval 61.8 to 70.7	58.0 percentage of participants Interval 53.4 to 62.6	63.9 percentage of participants Interval 58.5 to 69.4	49.9 percentage of participants Interval 45.2 to 54.6	—
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 2, 4, 12, and 24 Week 24	76.0 percentage of participants Interval 72.0 to 80.0	73.4 percentage of participants Interval 69.3 to 77.6	71.2 percentage of participants Interval 66.1 to 76.4	59.4 percentage of participants Interval 54.8 to 64.0	—

SECONDARY outcome

Timeframe: Weeks 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 0-3 \[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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 Week 36	77.1 percentage of participants Interval 73.2 to 81.1	74.9 percentage of participants Interval 70.9 to 79.0	71.5 percentage of participants Interval 66.4 to 76.7	83.2 percentage of participants Interval 77.6 to 88.9	77.7 percentage of participants Interval 71.4 to 83.9
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 36, and 52 Week 52	75.8 percentage of participants Interval 71.8 to 79.8	73.0 percentage of participants Interval 68.9 to 77.2	70.3 percentage of participants Interval 65.1 to 75.5	81.6 percentage of participants Interval 75.8 to 87.5	71.8 percentage of participants Interval 65.1 to 78.5

SECONDARY outcome

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

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 tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 Baseline	5.8 score on a scale Standard Deviation 0.88	5.7 score on a scale Standard Deviation 0.95	5.7 score on a scale Standard Deviation 0.88	5.7 score on a scale Standard Deviation 0.91	—
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-1.3 score on a scale Standard Deviation 1.05	-1.0 score on a scale Standard Deviation 0.90	-1.1 score on a scale Standard Deviation 0.90	-0.6 score on a scale Standard Deviation 0.79	—
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-1.7 score on a scale Standard Deviation 1.19	-1.4 score on a scale Standard Deviation 1.07	-1.4 score on a scale Standard Deviation 1.04	-0.9 score on a scale Standard Deviation 0.98	—
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-2.5 score on a scale Standard Deviation 1.24	-2.2 score on a scale Standard Deviation 1.17	-2.2 score on a scale Standard Deviation 1.12	-1.6 score on a scale Standard Deviation 1.19	—
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-3.1 score on a scale Standard Deviation 1.17	-2.8 score on a scale Standard Deviation 1.08	-2.7 score on a scale Standard Deviation 1.20	-2.2 score on a scale Standard Deviation 1.20	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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 tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 Baseline	5.8 score on a scale Standard Deviation 0.88	5.7 score on a scale Standard Deviation 0.95	5.7 score on a scale Standard Deviation 0.88	5.9 score on a scale Standard Deviation 0.89	5.6 score on a scale Standard Deviation 0.89
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 Change from Baseline at Week 36	-3.2 score on a scale Standard Deviation 1.09	-2.9 score on a scale Standard Deviation 1.17	-2.9 score on a scale Standard Deviation 1.16	-3.3 score on a scale Standard Deviation 1.10	-2.8 score on a scale Standard Deviation 1.08
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52 Change from Baseline at Week 52	-3.4 score on a scale Standard Deviation 1.11	-3.1 score on a scale Standard Deviation 1.09	-3.1 score on a scale Standard Deviation 1.13	-3.3 score on a scale Standard Deviation 1.16	-3.0 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Weeks 2, 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 Week 2	13.1 percentage of participants Interval 9.9 to 16.2	8.1 percentage of participants Interval 5.6 to 10.7	9.8 percentage of participants Interval 6.5 to 13.2	3.6 percentage of participants Interval 1.8 to 5.4	—
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 Week 4	25.5 percentage of participants Interval 21.5 to 29.5	20.4 percentage of participants Interval 16.7 to 24.1	20.9 percentage of participants Interval 16.3 to 25.5	9.3 percentage of participants Interval 6.6 to 12.0	—
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 2, 4, and 24 Week 24	60.6 percentage of participants Interval 56.1 to 65.1	53.1 percentage of participants Interval 48.6 to 57.7	50.5 percentage of participants Interval 44.9 to 56.1	33.7 percentage of participants Interval 29.3 to 38.0	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 Week 52	68.2 percentage of participants Interval 63.9 to 72.5	62.1 percentage of participants Interval 57.6 to 66.5	61.8 percentage of participants Interval 56.4 to 67.3	69.5 percentage of participants Interval 62.7 to 76.3	67.5 percentage of participants Interval 60.6 to 74.4
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 36, and 52 Week 36	67.4 percentage of participants Interval 63.0 to 71.7	60.2 percentage of participants Interval 55.7 to 64.7	58.2 percentage of participants Interval 52.6 to 63.7	74.7 percentage of participants Interval 68.3 to 81.2	66.5 percentage of participants Interval 59.5 to 73.4

SECONDARY outcome

Timeframe: Weeks 2, 4, and 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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 Week 2	5.1 percentage of participants Interval 3.0 to 7.1	1.7 percentage of participants Interval 0.4 to 2.9	3.4 percentage of participants Interval 1.3 to 5.5	0.6 percentage of participants Interval 0.0 to 1.4	—
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 Week 4	13.7 percentage of participants Interval 10.5 to 16.9	8.8 percentage of participants Interval 6.1 to 11.4	8.0 percentage of participants Interval 4.9 to 11.1	2.9 percentage of participants Interval 1.3 to 4.6	—
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24 Week 24	48.4 percentage of participants Interval 43.8 to 53.0	35.2 percentage of participants Interval 30.8 to 39.6	35.7 percentage of participants Interval 30.3 to 41.1	16.2 percentage of participants Interval 12.8 to 19.6	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 Week 36	50.3 percentage of participants Interval 45.7 to 54.9	42.9 percentage of participants Interval 38.4 to 47.4	42.5 percentage of participants Interval 36.9 to 48.0	52.1 percentage of participants Interval 44.7 to 59.5	46.1 percentage of participants Interval 38.7 to 53.4
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52 Week 52	54.5 percentage of participants Interval 49.9 to 59.1	44.8 percentage of participants Interval 40.2 to 49.3	48.6 percentage of participants Interval 43.0 to 54.2	50.5 percentage of participants Interval 43.2 to 57.9	50.8 percentage of participants Interval 43.4 to 58.1

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 Week 2	18.3 percent improvement Standard Deviation 19.98	14.0 percent improvement Standard Deviation 17.14	16.3 percent improvement Standard Deviation 18.41	8.0 percent improvement Standard Deviation 12.82	—
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 Week 4	27.4 percent improvement Standard Deviation 25.24	23.0 percent improvement Standard Deviation 22.26	23.8 percent improvement Standard Deviation 22.94	15.1 percent improvement Standard Deviation 18.92	—
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 Week 12	46.8 percent improvement Standard Deviation 28.46	40.6 percent improvement Standard Deviation 27.32	40.4 percent improvement Standard Deviation 26.18	28.1 percent improvement Standard Deviation 25.22	—
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24 Week 24	58.8 percent improvement Standard Deviation 27.76	55.4 percent improvement Standard Deviation 26.47	54.3 percent improvement Standard Deviation 28.13	42.6 percent improvement Standard Deviation 27.73	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 Week 36	62.5 percent improvement Standard Deviation 26.01	59.1 percent improvement Standard Deviation 27.47	58.6 percent improvement Standard Deviation 27.17	63.2 percent improvement Standard Deviation 24.59	56.1 percent improvement Standard Deviation 27.30
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52 Week 52	66.0 percent improvement Standard Deviation 25.89	63.1 percent improvement Standard Deviation 26.34	63.5 percent improvement Standard Deviation 27.03	63.8 percent improvement Standard Deviation 28.00	59.7 percent improvement Standard Deviation 26.81

SECONDARY outcome

Timeframe: Weeks 2, 4, 12, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 12 · Moderate Response	188 Participants	225 Participants	138 Participants	224 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 12 · No Response	33 Participants	50 Participants	32 Participants	101 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 24 · Good Response	284 Participants	250 Participants	163 Participants	154 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 24 · Moderate Response	124 Participants	156 Participants	97 Participants	170 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 24 · No Response	7 Participants	13 Participants	21 Participants	44 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 2 · Good Response	58 Participants	32 Participants	27 Participants	15 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 2 · Moderate Response	237 Participants	213 Participants	158 Participants	133 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 2 · No Response	157 Participants	219 Participants	129 Participants	313 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 4 · Good Response	117 Participants	86 Participants	61 Participants	37 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 4 · Moderate Response	231 Participants	242 Participants	156 Participants	189 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 4 · No Response	115 Participants	139 Participants	101 Participants	228 Participants	—
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24 Week 12 · Good Response	234 Participants	177 Participants	138 Participants	106 Participants	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Number of Participants With EULAR Response at Weeks 36, and 52 Week 52 · Moderate Response	82 Participants	98 Participants	66 Participants	38 Participants	42 Participants
Number of Participants With EULAR Response at Weeks 36, and 52 Week 36 · Good Response	306 Participants	276 Participants	180 Participants	139 Participants	124 Participants
Number of Participants With EULAR Response at Weeks 36, and 52 Week 36 · Moderate Response	99 Participants	126 Participants	84 Participants	38 Participants	54 Participants
Number of Participants With EULAR Response at Weeks 36, and 52 Week 36 · No Response	2 Participants	11 Participants	8 Participants	0 Participants	6 Participants
Number of Participants With EULAR Response at Weeks 36, and 52 Week 52 · Good Response	308 Participants	282 Participants	189 Participants	129 Participants	126 Participants
Number of Participants With EULAR Response at Weeks 36, and 52 Week 52 · No Response	3 Participants	5 Participants	4 Participants	2 Participants	3 Participants

SECONDARY outcome

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

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

CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 \[0 and 10 indicating no disease activity and maximum disease activity\]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-12.7 score on a scale Standard Deviation 11.86	-10.7 score on a scale Standard Deviation 11.17	-11.7 score on a scale Standard Deviation 10.06	-8.2 score on a scale Standard Deviation 10.10	—
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 Baseline	39.5 score on a scale Standard Deviation 11.85	38.6 score on a scale Standard Deviation 12.23	39.2 score on a scale Standard Deviation 11.51	39.6 score on a scale Standard Deviation 11.66	—
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-17.6 score on a scale Standard Deviation 12.66	-15.6 score on a scale Standard Deviation 12.07	-15.4 score on a scale Standard Deviation 11.13	-12.4 score on a scale Standard Deviation 11.79	—
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-26.0 score on a scale Standard Deviation 12.41	-23.3 score on a scale Standard Deviation 12.32	-23.5 score on a scale Standard Deviation 11.43	-20.3 score on a scale Standard Deviation 13.30	—
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-30.6 score on a scale Standard Deviation 11.88	-28.6 score on a scale Standard Deviation 11.57	-28.4 score on a scale Standard Deviation 11.45	-26.3 score on a scale Standard Deviation 12.38	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in CDAI at Weeks 36, and 52 Baseline	39.5 score on a scale Standard Deviation 11.85	38.6 score on a scale Standard Deviation 12.23	39.2 score on a scale Standard Deviation 11.51	41.4 score on a scale Standard Deviation 11.03	37.8 score on a scale Standard Deviation 11.23
Change From Baseline in CDAI at Weeks 36, and 52 Change from Baseline at Week 36	-32.1 score on a scale Standard Deviation 11.60	-29.9 score on a scale Standard Deviation 12.18	-30.4 score on a scale Standard Deviation 11.21	-33.8 score on a scale Standard Deviation 11.15	-29.0 score on a scale Standard Deviation 11.02
Change From Baseline in CDAI at Weeks 36, and 52 Change from Baseline at Week 52	-32.9 score on a scale Standard Deviation 11.69	-30.9 score on a scale Standard Deviation 11.70	-31.6 score on a scale Standard Deviation 11.44	-34.0 score on a scale Standard Deviation 11.20	-30.7 score on a scale Standard Deviation 10.80

SECONDARY outcome

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

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 0 to 86. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 2	-14.0 score on a scale Standard Deviation 12.19	-11.4 score on a scale Standard Deviation 11.41	-12.5 score on a scale Standard Deviation 10.52	-8.2 score on a scale Standard Deviation 10.38	—
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 12	-27.1 score on a scale Standard Deviation 12.69	-24.1 score on a scale Standard Deviation 12.54	-24.3 score on a scale Standard Deviation 12.03	-20.6 score on a scale Standard Deviation 13.85	—
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 24	-31.8 score on a scale Standard Deviation 12.18	-29.7 score on a scale Standard Deviation 12.01	-29.0 score on a scale Standard Deviation 12.19	-26.6 score on a scale Standard Deviation 12.91	—
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 Baseline	41.2 score on a scale Standard Deviation 12.26	40.2 score on a scale Standard Deviation 12.79	40.6 score on a scale Standard Deviation 11.88	41.2 score on a scale Standard Deviation 12.37	—
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24 Change from Baseline at Week 4	-18.6 score on a scale Standard Deviation 13.08	-16.4 score on a scale Standard Deviation 12.31	-16.1 score on a scale Standard Deviation 11.47	-12.5 score on a scale Standard Deviation 12.18	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in SDAI at Weeks 36, and 52 Baseline	41.2 score on a scale Standard Deviation 12.26	40.2 score on a scale Standard Deviation 12.79	40.6 score on a scale Standard Deviation 11.88	43.0 score on a scale Standard Deviation 11.81	39.4 score on a scale Standard Deviation 11.81
Change From Baseline in SDAI at Weeks 36, and 52 Change from Baseline at Week 52	-34.1 score on a scale Standard Deviation 12.15	-32.0 score on a scale Standard Deviation 12.25	-32.6 score on a scale Standard Deviation 11.99	-34.9 score on a scale Standard Deviation 11.83	-31.6 score on a scale Standard Deviation 11.11
Change From Baseline in SDAI at Weeks 36, and 52 Change from Baseline at Week 36	-33.3 score on a scale Standard Deviation 11.92	-31.0 score on a scale Standard Deviation 12.69	-31.2 score on a scale Standard Deviation 11.73	-35.1 score on a scale Standard Deviation 11.83	-29.9 score on a scale Standard Deviation 11.40

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 n=468 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=472 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=187 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=188 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in mTSS at Week 52 Baseline	32.62 score on a scale Standard Deviation 48.306	36.24 score on a scale Standard Deviation 52.956	33.94 score on a scale Standard Deviation 53.803	26.68 score on a scale Standard Deviation 45.870	32.38 score on a scale Standard Deviation 55.012
Change From Baseline in mTSS at Week 52 Change from Baseline at Week 52	0.21 score on a scale Standard Deviation 1.434	0.50 score on a scale Standard Deviation 2.098	0.58 score on a scale Standard Deviation 3.621	0.63 score on a scale Standard Deviation 2.782	0.90 score on a scale Standard Deviation 3.152

SECONDARY outcome

Timeframe: Baseline; Weeks 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. 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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants With no Radiographic Progression From Baseline at Week 24 Change in mTSS ≤ 0.5	93.8 percentage of participants Interval 91.4 to 96.3	91.1 percentage of participants Interval 88.2 to 94.0	91.9 percentage of participants Interval 88.4 to 95.3	87.2 percentage of participants Interval 83.5 to 90.8	—
Percentage of Participants With no Radiographic Progression From Baseline at Week 24 Change in mTSS ≤ 0	87.9 percentage of participants Interval 84.6 to 91.2	85.9 percentage of participants Interval 82.4 to 89.4	86.3 percentage of participants Interval 82.1 to 90.6	80.9 percentage of participants Interval 76.7 to 85.2	—
Percentage of Participants With no Radiographic Progression From Baseline at Week 24 Change in mTSS ≤ SDC (1.36)	95.8 percentage of participants Interval 93.7 to 97.9	95.0 percentage of participants Interval 92.8 to 97.3	94.5 percentage of participants Interval 91.6 to 97.4	90.3 percentage of participants Interval 87.1 to 93.6	—

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Percentage of Participants With no Radiographic Progression From Baseline at Week 52 Change in mTSS ≤ 0.5	92.1 percentage of participants Interval 89.4 to 94.8	87.1 percentage of participants Interval 83.7 to 90.5	88.6 percentage of participants Interval 84.7 to 92.6	83.9 percentage of participants Interval 78.2 to 89.5	83.7 percentage of participants Interval 78.0 to 89.4
Percentage of Participants With no Radiographic Progression From Baseline at Week 52 Change in mTSS ≤ 0	87.5 percentage of participants Interval 84.2 to 90.8	81.3 percentage of participants Interval 77.4 to 85.2	82.4 percentage of participants Interval 77.7 to 87.1	73.3 percentage of participants Interval 66.6 to 80.1	77.0 percentage of participants Interval 70.5 to 83.4
Percentage of Participants With no Radiographic Progression From Baseline at Week 52 Change in mTSS ≤ SDC (1.83)	95.0 percentage of participants Interval 92.7 to 97.2	91.5 percentage of participants Interval 88.7 to 94.3	94.1 percentage of participants Interval 91.2 to 97.1	90.0 percentage of participants Interval 85.3 to 94.7	87.6 percentage of participants Interval 82.5 to 92.8

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 Week 4	39.0 score on a scale Standard Deviation 8.22	38.2 score on a scale Standard Deviation 8.35	37.7 score on a scale Standard Deviation 8.07	36.1 score on a scale Standard Deviation 7.40	—
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 Week 12	42.7 score on a scale Standard Deviation 8.30	42.1 score on a scale Standard Deviation 8.69	41.3 score on a scale Standard Deviation 8.57	38.8 score on a scale Standard Deviation 7.83	—
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24 Week 24	43.9 score on a scale Standard Deviation 8.49	43.7 score on a scale Standard Deviation 8.64	43.2 score on a scale Standard Deviation 8.95	40.7 score on a scale Standard Deviation 8.10	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
SF-36 PCS Score at Weeks 36, and 52 Week 36	45.2 score on a scale Standard Deviation 8.28	44.4 score on a scale Standard Deviation 8.54	43.8 score on a scale Standard Deviation 8.84	45.2 score on a scale Standard Deviation 7.99	43.2 score on a scale Standard Deviation 8.82
SF-36 PCS Score at Weeks 36, and 52 Week 52	45.6 score on a scale Standard Deviation 8.35	45.1 score on a scale Standard Deviation 8.57	45.2 score on a scale Standard Deviation 8.55	45.1 score on a scale Standard Deviation 8.26	44.1 score on a scale Standard Deviation 8.88

SECONDARY outcome

Timeframe: Baseline; Weeks 4, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=473 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=479 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=323 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=474 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 Baseline	33.4 score on a scale Standard Deviation 7.17	33.6 score on a scale Standard Deviation 7.75	32.8 score on a scale Standard Deviation 7.74	32.9 score on a scale Standard Deviation 7.11	—
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 Change from Baseline at Week 4	5.6 score on a scale Standard Deviation 6.57	4.6 score on a scale Standard Deviation 6.50	5.0 score on a scale Standard Deviation 6.65	3.1 score on a scale Standard Deviation 6.32	—
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24 Change from Baseline at Week 24	10.4 score on a scale Standard Deviation 8.49	10.3 score on a scale Standard Deviation 8.64	10.4 score on a scale Standard Deviation 8.47	7.7 score on a scale Standard Deviation 7.97	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=473 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=479 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=323 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 Baseline	33.4 score on a scale Standard Deviation 7.17	33.6 score on a scale Standard Deviation 7.75	32.8 score on a scale Standard Deviation 7.74	32.2 score on a scale Standard Deviation 6.96	33.7 score on a scale Standard Deviation 6.96
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 Change from Baseline at Week 36	11.6 score on a scale Standard Deviation 8.28	11.0 score on a scale Standard Deviation 8.53	11.1 score on a scale Standard Deviation 9.07	12.9 score on a scale Standard Deviation 8.92	9.5 score on a scale Standard Deviation 8.13
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52 Change from Baseline at Week 52	12.0 score on a scale Standard Deviation 8.73	11.5 score on a scale Standard Deviation 8.74	12.4 score on a scale Standard Deviation 9.21	13.0 score on a scale Standard Deviation 9.58	10.4 score on a scale Standard Deviation 8.05

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 Week 24	50.0 score on a scale Standard Deviation 8.82	50.2 score on a scale Standard Deviation 8.93	49.3 score on a scale Standard Deviation 10.26	49.2 score on a scale Standard Deviation 9.90	—
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 Week 4	47.8 score on a scale Standard Deviation 9.90	47.9 score on a scale Standard Deviation 9.63	47.9 score on a scale Standard Deviation 10.04	45.8 score on a scale Standard Deviation 10.35	—
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24 Week 12	49.3 score on a scale Standard Deviation 9.14	49.9 score on a scale Standard Deviation 8.90	48.9 score on a scale Standard Deviation 10.28	47.7 score on a scale Standard Deviation 10.16	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
SF-36 MCS Score at Weeks 36, and 52 Week 36	50.1 score on a scale Standard Deviation 8.96	51.3 score on a scale Standard Deviation 8.88	50.7 score on a scale Standard Deviation 9.67	50.7 score on a scale Standard Deviation 9.04	50.3 score on a scale Standard Deviation 9.47
SF-36 MCS Score at Weeks 36, and 52 Week 52	50.6 score on a scale Standard Deviation 9.30	51.5 score on a scale Standard Deviation 8.99	50.8 score on a scale Standard Deviation 9.51	50.8 score on a scale Standard Deviation 8.55	50.1 score on a scale Standard Deviation 9.21

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=473 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=479 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=323 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=474 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 Baseline	43.9 score on a scale Standard Deviation 10.44	44.6 score on a scale Standard Deviation 10.44	44.1 score on a scale Standard Deviation 10.44	43.4 score on a scale Standard Deviation 11.01	—
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 Change from Baseline at Week 4	3.9 score on a scale Standard Deviation 7.96	3.4 score on a scale Standard Deviation 8.35	3.7 score on a scale Standard Deviation 7.66	2.3 score on a scale Standard Deviation 8.72	—
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 Change from Baseline at Week 12	5.4 score on a scale Standard Deviation 9.45	5.4 score on a scale Standard Deviation 8.97	4.9 score on a scale Standard Deviation 9.69	4.1 score on a scale Standard Deviation 9.50	—
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24 Change from Baseline at Week 24	6.1 score on a scale Standard Deviation 9.23	5.7 score on a scale Standard Deviation 9.57	5.3 score on a scale Standard Deviation 9.25	5.6 score on a scale Standard Deviation 10.28	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=473 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=479 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=323 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 Baseline	43.9 score on a scale Standard Deviation 10.44	44.6 score on a scale Standard Deviation 10.44	44.1 score on a scale Standard Deviation 10.44	43.9 score on a scale Standard Deviation 11.06	43.4 score on a scale Standard Deviation 11.03
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 Change from Baseline at Week 36	6.2 score on a scale Standard Deviation 10.03	6.6 score on a scale Standard Deviation 10.46	6.6 score on a scale Standard Deviation 9.40	6.9 score on a scale Standard Deviation 12.05	6.8 score on a scale Standard Deviation 9.84
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52 Change from Baseline at Week 52	6.7 score on a scale Standard Deviation 10.53	6.9 score on a scale Standard Deviation 10.61	6.7 score on a scale Standard Deviation 9.90	7.2 score on a scale Standard Deviation 11.31	6.5 score on a scale Standard Deviation 10.35

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 Week 4	33.9 score on a scale Standard Deviation 10.32	33.3 score on a scale Standard Deviation 9.76	32.9 score on a scale Standard Deviation 10.11	30.9 score on a scale Standard Deviation 10.43	—
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 Week 12	36.8 score on a scale Standard Deviation 9.64	36.7 score on a scale Standard Deviation 9.67	36.1 score on a scale Standard Deviation 9.68	33.9 score on a scale Standard Deviation 10.32	—
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24 Week 24	38.5 score on a scale Standard Deviation 9.17	38.5 score on a scale Standard Deviation 8.74	37.6 score on a scale Standard Deviation 9.82	35.8 score on a scale Standard Deviation 9.94	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
FACIT-Fatigue Score at Weeks 36, and 52 Week 52	39.8 score on a scale Standard Deviation 8.64	39.8 score on a scale Standard Deviation 8.54	38.9 score on a scale Standard Deviation 9.87	39.4 score on a scale Standard Deviation 8.78	38.0 score on a scale Standard Deviation 9.77
FACIT-Fatigue Score at Weeks 36, and 52 Week 36	38.9 score on a scale Standard Deviation 8.84	39.5 score on a scale Standard Deviation 8.73	38.6 score on a scale Standard Deviation 9.45	39.6 score on a scale Standard Deviation 8.78	37.4 score on a scale Standard Deviation 9.88

SECONDARY outcome

Timeframe: Baseline; Weeks 4, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=469 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 Change from Baseline at Week 24	10.5 score on a scale Standard Deviation 10.63	10.8 score on a scale Standard Deviation 10.77	10.3 score on a scale Standard Deviation 9.67	8.4 score on a scale Standard Deviation 10.48	—
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 Baseline	27.6 score on a scale Standard Deviation 10.68	27.8 score on a scale Standard Deviation 10.60	27.2 score on a scale Standard Deviation 10.20	26.9 score on a scale Standard Deviation 10.34	—
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24 Change from Baseline at Week 4	6.3 score on a scale Standard Deviation 8.59	5.7 score on a scale Standard Deviation 8.77	5.7 score on a scale Standard Deviation 8.47	3.8 score on a scale Standard Deviation 8.76	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=189 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=189 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 Change from Baseline at Week 52	11.9 score on a scale Standard Deviation 10.21	12.2 score on a scale Standard Deviation 10.88	11.7 score on a scale Standard Deviation 10.79	12.9 score on a scale Standard Deviation 11.55	10.1 score on a scale Standard Deviation 10.06
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 Baseline	27.6 score on a scale Standard Deviation 10.68	27.8 score on a scale Standard Deviation 10.60	27.2 score on a scale Standard Deviation 10.20	26.8 score on a scale Standard Deviation 10.13	27.9 score on a scale Standard Deviation 10.56
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52 Change from Baseline at Week 36	11.0 score on a scale Standard Deviation 10.22	11.7 score on a scale Standard Deviation 10.90	11.3 score on a scale Standard Deviation 10.18	12.8 score on a scale Standard Deviation 10.76	9.5 score on a scale Standard Deviation 10.25

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 12 · Slight Problems	149 Participants	150 Participants	102 Participants	159 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 24 · Moderate Problems	45 Participants	39 Participants	36 Participants	54 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 4 · Slight Problems	203 Participants	193 Participants	133 Participants	195 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 4 · Moderate Problems	111 Participants	142 Participants	90 Participants	143 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 12 · Slight Problems	200 Participants	191 Participants	130 Participants	184 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 24 · Slight Problems	164 Participants	171 Participants	105 Participants	163 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 24 · Moderate Problems	54 Participants	63 Participants	52 Participants	86 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 4 · No Problems	42 Participants	38 Participants	26 Participants	14 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 4 · Moderate Problems	154 Participants	204 Participants	127 Participants	198 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 4 · Severe Problems	51 Participants	41 Participants	47 Participants	80 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 12 · Severe Problems	20 Participants	17 Participants	22 Participants	51 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 24 · No Problems	82 Participants	78 Participants	56 Participants	39 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 24 · Slight Problems	226 Participants	224 Participants	127 Participants	196 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 4 · Moderate Problems	72 Participants	81 Participants	44 Participants	86 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 12 · Severe Problems	12 Participants	5 Participants	4 Participants	19 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 12 · Extreme Problems	0 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, and 24 Anxiety/Depression: Week 24 · Slight Problems	136 Participants	119 Participants	75 Participants	120 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 24 · Extreme Problems	0 Participants	2 Participants	3 Participants	1 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 24 · Severe Problems	8 Participants	5 Participants	6 Participants	8 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 4 · No Problems	130 Participants	129 Participants	84 Participants	100 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 4 · Slight Problems	176 Participants	173 Participants	107 Participants	149 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 4 · Moderate Problems	113 Participants	122 Participants	96 Participants	150 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 4 · Severe Problems	44 Participants	46 Participants	31 Participants	56 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 12 · Moderate Problems	99 Participants	97 Participants	67 Participants	112 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 4 · Extreme Problems	5 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, and 24 Mobility: Week 12 · No Problems	178 Participants	177 Participants	116 Participants	132 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 12 · Slight Problems	153 Participants	151 Participants	103 Participants	154 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 12 · Severe Problems	21 Participants	31 Participants	21 Participants	38 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: Week 12 · Extreme Problems	4 Participants	1 Participants	0 Participants	1 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: week 24 · No Problems	182 Participants	189 Participants	117 Participants	131 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: week 24 · Slight Problems	142 Participants	136 Participants	90 Participants	126 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: week 24 · Moderate Problems	68 Participants	75 Participants	57 Participants	89 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: week 24 · Severe Problems	19 Participants	17 Participants	12 Participants	24 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Mobility: week 24 · Extreme Problems	5 Participants	2 Participants	1 Participants	2 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 4 · No Problems	177 Participants	163 Participants	111 Participants	138 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 4 · Slight Problems	180 Participants	183 Participants	120 Participants	164 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 4 · Moderate Problems	86 Participants	103 Participants	74 Participants	124 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 4 · Severe Problems	23 Participants	20 Participants	13 Participants	25 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 4 · Extreme Problems	2 Participants	2 Participants	1 Participants	6 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 12 · No Problems	243 Participants	222 Participants	147 Participants	165 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 12 · Moderate Problems	53 Participants	74 Participants	49 Participants	88 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 12 · Severe Problems	8 Participants	9 Participants	9 Participants	21 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 12 · Extreme Problems	2 Participants	2 Participants	0 Participants	4 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 24 · No Problems	255 Participants	249 Participants	157 Participants	164 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 24 · Slight Problems	109 Participants	121 Participants	75 Participants	140 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 24 · Severe Problems	4 Participants	8 Participants	7 Participants	14 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Self-care: Week 24 · Extreme Problems	3 Participants	2 Participants	2 Participants	0 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 4 · No Problems	110 Participants	102 Participants	69 Participants	65 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 4 · Slight Problems	215 Participants	185 Participants	118 Participants	157 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 4 · Severe Problems	38 Participants	33 Participants	25 Participants	52 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 4 · Extreme Problems	6 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, and 24 Usual Activities: Week 12 · No Problems	157 Participants	149 Participants	97 Participants	103 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 12 · Moderate Problems	80 Participants	90 Participants	67 Participants	116 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 12 · Severe Problems	16 Participants	23 Participants	13 Participants	32 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 12 · Extreme Problems	2 Participants	4 Participants	0 Participants	2 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 24 · No Problems	184 Participants	175 Participants	109 Participants	107 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 24 · Severe Problems	13 Participants	9 Participants	9 Participants	15 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Usual Activities: Week 24 · Extreme Problems	1 Participants	1 Participants	2 Participants	1 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 4 · Extreme Problems	6 Participants	3 Participants	1 Participants	8 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 12 · No Problems	58 Participants	71 Participants	34 Participants	29 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 12 · Slight Problems	260 Participants	217 Participants	145 Participants	200 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 12 · Moderate Problems	117 Participants	150 Participants	106 Participants	154 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 12 · Extreme Problems	0 Participants	2 Participants	0 Participants	3 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 24 · Moderate Problems	86 Participants	103 Participants	82 Participants	110 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 24 · Severe Problems	21 Participants	13 Participants	12 Participants	27 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Pain/Discomfort: Week 24 · Extreme Problems	1 Participants	1 Participants	0 Participants	0 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 4 · No Problems	211 Participants	224 Participants	151 Participants	196 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 4 · Slight Problems	163 Participants	158 Participants	111 Participants	149 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 4 · Severe Problems	21 Participants	8 Participants	13 Participants	25 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 4 · Extreme Problems	1 Participants	0 Participants	0 Participants	1 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 12 · No Problems	235 Participants	246 Participants	152 Participants	216 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 12 · Slight Problems	154 Participants	143 Participants	106 Participants	137 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 12 · Moderate Problems	54 Participants	63 Participants	44 Participants	62 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 24 · No Problems	230 Participants	256 Participants	160 Participants	204 Participants	—
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24 Anxiety/Depression: Week 24 · Moderate Problems	42 Participants	37 Participants	33 Participants	39 Participants	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 52 · Extreme Problems	4 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 36 · No Problems	254 Participants	249 Participants	164 Participants	114 Participants	108 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 36 · Slight Problems	104 Participants	113 Participants	67 Participants	45 Participants	46 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 52 · Moderate Problems	30 Participants	25 Participants	24 Participants	16 Participants	18 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 36 · No Problems	176 Participants	172 Participants	125 Participants	82 Participants	72 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 36 · Slight Problems	160 Participants	171 Participants	90 Participants	71 Participants	70 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 36 · Severe Problems	7 Participants	9 Participants	7 Participants	3 Participants	5 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 36 · Extreme Problems	2 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 52 · No Problems	183 Participants	177 Participants	121 Participants	75 Participants	71 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 52 · Slight Problems	151 Participants	147 Participants	87 Participants	64 Participants	72 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 52 · Moderate Problems	40 Participants	41 Participants	42 Participants	22 Participants	19 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 52 · Severe Problems	8 Participants	12 Participants	6 Participants	5 Participants	12 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 52 · Extreme Problems	4 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 36 · No Problems	95 Participants	84 Participants	55 Participants	47 Participants	35 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 36 · Slight Problems	206 Participants	220 Participants	127 Participants	94 Participants	97 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 52 · Severe Problems	5 Participants	5 Participants	4 Participants	0 Participants	4 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 36 · No Problems	202 Participants	189 Participants	122 Participants	86 Participants	78 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 36 · Slight Problems	121 Participants	136 Participants	82 Participants	58 Participants	67 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 36 · Moderate Problems	58 Participants	64 Participants	48 Participants	26 Participants	28 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 36 · Severe Problems	13 Participants	15 Participants	16 Participants	7 Participants	11 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 36 · Extreme Problems	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 52 · No Problems	197 Participants	187 Participants	130 Participants	82 Participants	77 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 52 · Slight Problems	117 Participants	115 Participants	79 Participants	47 Participants	61 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 52 · Moderate Problems	57 Participants	58 Participants	38 Participants	34 Participants	27 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Mobility: Week 52 · Severe Problems	11 Participants	19 Participants	10 Participants	3 Participants	8 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 36 · Moderate Problems	31 Participants	36 Participants	30 Participants	17 Participants	25 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 36 · Severe Problems	5 Participants	5 Participants	6 Participants	1 Participants	5 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 36 · Extreme Problems	1 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 52 · No Problems	251 Participants	245 Participants	159 Participants	105 Participants	101 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 52 · Slight Problems	98 Participants	102 Participants	72 Participants	44 Participants	48 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 52 · Severe Problems	5 Participants	6 Participants	2 Participants	1 Participants	6 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Self-care: Week 52 · Extreme Problems	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Usual Activities: Week 36 · Moderate Problems	50 Participants	52 Participants	46 Participants	21 Participants	36 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 36 · Moderate Problems	81 Participants	89 Participants	79 Participants	34 Participants	45 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 36 · Severe Problems	13 Participants	11 Participants	8 Participants	2 Participants	7 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 36 · Extreme Problems	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 52 · No Problems	90 Participants	88 Participants	57 Participants	45 Participants	44 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 52 · Slight Problems	209 Participants	210 Participants	130 Participants	80 Participants	93 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 52 · Moderate Problems	77 Participants	72 Participants	61 Participants	38 Participants	31 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 52 · Severe Problems	10 Participants	9 Participants	9 Participants	3 Participants	6 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Pain/Discomfort: Week 52 · Extreme Problems	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 36 · No Problems	230 Participants	259 Participants	162 Participants	115 Participants	112 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 36 · Slight Problems	123 Participants	113 Participants	79 Participants	44 Participants	51 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 36 · Moderate Problems	37 Participants	27 Participants	19 Participants	18 Participants	16 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 36 · Severe Problems	4 Participants	5 Participants	7 Participants	0 Participants	5 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 36 · Extreme Problems	1 Participants	1 Participants	3 Participants	0 Participants	0 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 52 · No Problems	227 Participants	254 Participants	169 Participants	111 Participants	110 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 52 · Slight Problems	106 Participants	86 Participants	61 Participants	38 Participants	41 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 52 · Moderate Problems	48 Participants	34 Participants	23 Participants	17 Participants	19 Participants
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52 Anxiety/Depression: Week 52 · Extreme Problems	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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 n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
EQ-5D Current Health VAS at Weeks 4, 12, and 24 Week 12	66 score on a scale Standard Deviation 20.3	66 score on a scale Standard Deviation 20.3	65 score on a scale Standard Deviation 19.6	59 score on a scale Standard Deviation 20.7	—
EQ-5D Current Health VAS at Weeks 4, 12, and 24 Week 4	59 score on a scale Standard Deviation 20.5	59 score on a scale Standard Deviation 19.9	60 score on a scale Standard Deviation 20.4	56 score on a scale Standard Deviation 19.5	—
EQ-5D Current Health VAS at Weeks 4, 12, and 24 Week 24	67 score on a scale Standard Deviation 23.1	69 score on a scale Standard Deviation 21.6	68 score on a scale Standard Deviation 22.2	64 score on a scale Standard Deviation 21.4	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
EQ-5D Current Health VAS at Weeks 36, and 52 Week 36	69 score on a scale Standard Deviation 22.7	72 score on a scale Standard Deviation 21.2	67 score on a scale Standard Deviation 24.3	73 score on a scale Standard Deviation 19.9	71 score on a scale Standard Deviation 21.1
EQ-5D Current Health VAS at Weeks 36, and 52 Week 52	72 score on a scale Standard Deviation 21.3	73 score on a scale Standard Deviation 21.0	71 score on a scale Standard Deviation 22.5	73 score on a scale Standard Deviation 20.6	70 score on a scale Standard Deviation 22.8

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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 n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=469 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 Change from Baseline at Week 4	11 score on a scale Standard Deviation 24.4	10 score on a scale Standard Deviation 25.2	13 score on a scale Standard Deviation 24.4	10 score on a scale Standard Deviation 25.1	—
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 Change from Baseline at Week 24	19 score on a scale Standard Deviation 30.5	21 score on a scale Standard Deviation 28.9	21 score on a scale Standard Deviation 28.8	18 score on a scale Standard Deviation 29.3	—
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 Baseline	48 score on a scale Standard Deviation 22.5	49 score on a scale Standard Deviation 22.8	47 score on a scale Standard Deviation 21.8	46 score on a scale Standard Deviation 21.8	—
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24 Change from Baseline at Week 12	18 score on a scale Standard Deviation 26.3	17 score on a scale Standard Deviation 27.4	17 score on a scale Standard Deviation 27.1	13 score on a scale Standard Deviation 26.5	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=189 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=189 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 Change from Baseline at Week 36	21 score on a scale Standard Deviation 30.6	23 score on a scale Standard Deviation 28.5	20 score on a scale Standard Deviation 30.9	28 score on a scale Standard Deviation 28.2	24 score on a scale Standard Deviation 26.0
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 Change from Baseline at Week 52	25 score on a scale Standard Deviation 29.3	24 score on a scale Standard Deviation 28.5	24 score on a scale Standard Deviation 29.2	29 score on a scale Standard Deviation 28.6	23 score on a scale Standard Deviation 29.6
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52 Baseline	48 score on a scale Standard Deviation 22.5	49 score on a scale Standard Deviation 22.8	47 score on a scale Standard Deviation 21.8	45 score on a scale Standard Deviation 21.6	47 score on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Week 4	8.5 percentage of work time missed Standard Deviation 21.27	6.6 percentage of work time missed Standard Deviation 16.47	9.2 percentage of work time missed Standard Deviation 21.99	9.4 percentage of work time missed Standard Deviation 21.41	—
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Week 12	6.6 percentage of work time missed Standard Deviation 17.06	5.4 percentage of work time missed Standard Deviation 14.56	7.1 percentage of work time missed Standard Deviation 18.46	9.5 percentage of work time missed Standard Deviation 22.66	—
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Week 24	4.4 percentage of work time missed Standard Deviation 13.54	3.6 percentage of work time missed Standard Deviation 10.24	7.2 percentage of work time missed Standard Deviation 17.72	10.5 percentage of work time missed Standard Deviation 21.86	—

SECONDARY outcome

Timeframe: Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 Week 36	5.5 percentage of work time missed Standard Deviation 16.17	7.7 percentage of work time missed Standard Deviation 19.46	7.0 percentage of work time missed Standard Deviation 19.65	6.8 percentage of work time missed Standard Deviation 19.79	8.4 percentage of work time missed Standard Deviation 19.97
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 Week 52	4.8 percentage of work time missed Standard Deviation 14.39	5.4 percentage of work time missed Standard Deviation 15.10	7.4 percentage of work time missed Standard Deviation 20.12	5.5 percentage of work time missed Standard Deviation 13.24	5.8 percentage of work time missed Standard Deviation 14.29

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Week 4	34.3 percentage of impairment while working Standard Deviation 22.69	36.9 percentage of impairment while working Standard Deviation 24.01	35.6 percentage of impairment while working Standard Deviation 22.39	42.5 percentage of impairment while working Standard Deviation 23.54	—
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Week 12	26.3 percentage of impairment while working Standard Deviation 21.07	26.9 percentage of impairment while working Standard Deviation 22.57	27.6 percentage of impairment while working Standard Deviation 21.51	34.0 percentage of impairment while working Standard Deviation 21.98	—
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Week 24	22.0 percentage of impairment while working Standard Deviation 21.28	21.0 percentage of impairment while working Standard Deviation 20.74	25.7 percentage of impairment while working Standard Deviation 21.99	30.9 percentage of impairment while working Standard Deviation 23.11	—

SECONDARY outcome

Timeframe: Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 Week 36	20.2 percentage of impairment while working Standard Deviation 19.54	19.6 percentage of impairment while working Standard Deviation 20.27	21.2 percentage of impairment while working Standard Deviation 20.74	21.5 percentage of impairment while working Standard Deviation 18.72	25.8 percentage of impairment while working Standard Deviation 23.51
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 Week 52	18.2 percentage of impairment while working Standard Deviation 18.83	17.3 percentage of impairment while working Standard Deviation 19.25	20.8 percentage of impairment while working Standard Deviation 21.78	22.3 percentage of impairment while working Standard Deviation 21.82	19.5 percentage of impairment while working Standard Deviation 20.04

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Week 4	37.0 percentage of work productivity loss Standard Deviation 24.64	39.5 percentage of work productivity loss Standard Deviation 25.17	38.4 percentage of work productivity loss Standard Deviation 24.59	45.1 percentage of work productivity loss Standard Deviation 25.18	—
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Week 12	29.5 percentage of work productivity loss Standard Deviation 24.25	29.3 percentage of work productivity loss Standard Deviation 24.73	30.7 percentage of work productivity loss Standard Deviation 24.34	36.7 percentage of work productivity loss Standard Deviation 24.27	—
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Week 24	24.4 percentage of work productivity loss Standard Deviation 23.06	23.2 percentage of work productivity loss Standard Deviation 22.64	29.1 percentage of work productivity loss Standard Deviation 23.88	34.9 percentage of work productivity loss Standard Deviation 26.04	—

SECONDARY outcome

Timeframe: Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 Week 36	23.3 percentage of work productivity loss Standard Deviation 22.02	23.9 percentage of work productivity loss Standard Deviation 23.98	23.8 percentage of work productivity loss Standard Deviation 22.95	24.0 percentage of work productivity loss Standard Deviation 21.33	29.1 percentage of work productivity loss Standard Deviation 26.79
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 Week 52	20.6 percentage of work productivity loss Standard Deviation 21.74	20.5 percentage of work productivity loss Standard Deviation 22.15	24.3 percentage of work productivity loss Standard Deviation 24.77	25.7 percentage of work productivity loss Standard Deviation 24.32	22.3 percentage of work productivity loss Standard Deviation 24.10

SECONDARY outcome

Timeframe: Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=475 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Week 4	44.6 percentage of activity impairment Standard Deviation 24.18	46.2 percentage of activity impairment Standard Deviation 24.05	46.4 percentage of activity impairment Standard Deviation 23.84	52.1 percentage of activity impairment Standard Deviation 23.41	—
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Week 12	35.1 percentage of activity impairment Standard Deviation 23.86	36.6 percentage of activity impairment Standard Deviation 24.51	38.3 percentage of activity impairment Standard Deviation 25.57	44.3 percentage of activity impairment Standard Deviation 23.73	—
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Week 24	30.2 percentage of activity impairment Standard Deviation 24.69	30.4 percentage of activity impairment Standard Deviation 23.07	32.5 percentage of activity impairment Standard Deviation 24.40	39.3 percentage of activity impairment Standard Deviation 23.69	—

SECONDARY outcome

Timeframe: Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=475 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=325 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=190 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=191 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 Week 36	28.3 percentage of activity impairment Standard Deviation 23.30	28.7 percentage of activity impairment Standard Deviation 23.47	31.3 percentage of activity impairment Standard Deviation 25.44	28.3 percentage of activity impairment Standard Deviation 22.47	32.3 percentage of activity impairment Standard Deviation 23.62
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 Week 52	26.0 percentage of activity impairment Standard Deviation 22.44	26.3 percentage of activity impairment Standard Deviation 22.71	28.1 percentage of activity impairment Standard Deviation 24.38	28.6 percentage of activity impairment Standard Deviation 23.57	28.9 percentage of activity impairment Standard Deviation 23.07

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=195 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=193 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=127 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=162 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Baseline	12.0 percentage of work time missed Standard Deviation 25.77	9.9 percentage of work time missed Standard Deviation 20.91	16.0 percentage of work time missed Standard Deviation 27.57	17.0 percentage of work time missed Standard Deviation 29.52	—
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 4	-1.4 percentage of work time missed Standard Deviation 21.24	-2.1 percentage of work time missed Standard Deviation 18.14	-7.5 percentage of work time missed Standard Deviation 24.26	-5.7 percentage of work time missed Standard Deviation 25.65	—
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 12	-4.3 percentage of work time missed Standard Deviation 22.55	-3.8 percentage of work time missed Standard Deviation 18.37	-7.5 percentage of work time missed Standard Deviation 28.79	-5.9 percentage of work time missed Standard Deviation 27.94	—
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 24	-6.1 percentage of work time missed Standard Deviation 24.77	-3.8 percentage of work time missed Standard Deviation 16.92	-9.3 percentage of work time missed Standard Deviation 28.99	-1.5 percentage of work time missed Standard Deviation 27.24	—

SECONDARY outcome

Timeframe: Baseline; Weeks 36, and 52

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

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=195 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=193 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=127 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=76 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=62 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 Baseline	12.0 percentage of work time missed Standard Deviation 25.77	9.9 percentage of work time missed Standard Deviation 20.91	16.0 percentage of work time missed Standard Deviation 27.57	18.3 percentage of work time missed Standard Deviation 31.61	14.6 percentage of work time missed Standard Deviation 26.88
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 Change from Baseline at Week 36	-4.4 percentage of work time missed Standard Deviation 24.04	-1.5 percentage of work time missed Standard Deviation 24.41	-8.7 percentage of work time missed Standard Deviation 27.43	-6.2 percentage of work time missed Standard Deviation 30.25	-7.5 percentage of work time missed Standard Deviation 25.00
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52 Change from Baseline at Week 52	-6.8 percentage of work time missed Standard Deviation 26.27	-1.7 percentage of work time missed Standard Deviation 21.89	-7.1 percentage of work time missed Standard Deviation 24.00	-7.4 percentage of work time missed Standard Deviation 26.76	-8.9 percentage of work time missed Standard Deviation 27.90

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=184 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=187 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=119 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=150 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 24	-27.4 percentage of impairment while working Standard Deviation 26.37	-25.9 percentage of impairment while working Standard Deviation 26.59	-23.3 percentage of impairment while working Standard Deviation 27.56	-21.2 percentage of impairment while working Standard Deviation 29.33	—
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Baseline	49.1 percentage of impairment while working Standard Deviation 25.23	48.0 percentage of impairment while working Standard Deviation 24.61	50.8 percentage of impairment while working Standard Deviation 22.98	52.5 percentage of impairment while working Standard Deviation 25.89	—
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 4	-15.1 percentage of impairment while working Standard Deviation 23.19	-10.2 percentage of impairment while working Standard Deviation 22.82	-15.3 percentage of impairment while working Standard Deviation 24.84	-9.5 percentage of impairment while working Standard Deviation 23.68	—
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24 Change from Baseline at Week 12	-24.1 percentage of impairment while working Standard Deviation 25.83	-21.9 percentage of impairment while working Standard Deviation 23.22	-22.9 percentage of impairment while working Standard Deviation 24.88	-17.1 percentage of impairment while working Standard Deviation 27.24	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=184 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=187 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=119 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=69 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=59 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 Baseline	49.1 percentage of impairment while working Standard Deviation 25.23	48.0 percentage of impairment while working Standard Deviation 24.61	50.8 percentage of impairment while working Standard Deviation 22.98	53.8 percentage of impairment while working Standard Deviation 26.35	53.6 percentage of impairment while working Standard Deviation 23.40
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 Change from Baseline at Week 36	-29.7 percentage of impairment while working Standard Deviation 26.73	-27.5 percentage of impairment while working Standard Deviation 26.28	-27.8 percentage of impairment while working Standard Deviation 29.90	-32.0 percentage of impairment while working Standard Deviation 26.82	-26.4 percentage of impairment while working Standard Deviation 29.86
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52 Change from Baseline at Week 52	-31.7 percentage of impairment while working Standard Deviation 27.44	-29.5 percentage of impairment while working Standard Deviation 24.66	-29.4 percentage of impairment while working Standard Deviation 27.91	-30.6 percentage of impairment while working Standard Deviation 28.24	-32.5 percentage of impairment while working Standard Deviation 28.17

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=184 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=187 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=119 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=150 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Baseline	51.3 percentage of work productivity loss Standard Deviation 25.95	50.6 percentage of work productivity loss Standard Deviation 25.87	54.3 percentage of work productivity loss Standard Deviation 24.85	55.8 percentage of work productivity loss Standard Deviation 27.33	—
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 4	-14.6 percentage of work productivity loss Standard Deviation 24.59	-10.2 percentage of work productivity loss Standard Deviation 23.71	-16.8 percentage of work productivity loss Standard Deviation 26.29	-10.0 percentage of work productivity loss Standard Deviation 24.06	—
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 12	-23.2 percentage of work productivity loss Standard Deviation 28.18	-22.3 percentage of work productivity loss Standard Deviation 24.34	-22.8 percentage of work productivity loss Standard Deviation 26.61	-17.5 percentage of work productivity loss Standard Deviation 28.09	—
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 24	-27.1 percentage of work productivity loss Standard Deviation 27.78	-26.3 percentage of work productivity loss Standard Deviation 27.29	-23.6 percentage of work productivity loss Standard Deviation 29.40	-19.3 percentage of work productivity loss Standard Deviation 30.81	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + \[(1-Q2/(Q2+Q4) × (Q5/10)\]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=184 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=187 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=119 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=69 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=59 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 Baseline	51.3 percentage of work productivity loss Standard Deviation 25.95	50.6 percentage of work productivity loss Standard Deviation 25.87	54.3 percentage of work productivity loss Standard Deviation 24.85	56.6 percentage of work productivity loss Standard Deviation 27.36	57.1 percentage of work productivity loss Standard Deviation 25.14
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 Change from Baseline at Week 36	-28.9 percentage of work productivity loss Standard Deviation 27.16	-25.7 percentage of work productivity loss Standard Deviation 29.54	-28.6 percentage of work productivity loss Standard Deviation 31.48	-31.7 percentage of work productivity loss Standard Deviation 30.53	-26.9 percentage of work productivity loss Standard Deviation 31.02
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52 Change from Baseline at Week 52	-31.6 percentage of work productivity loss Standard Deviation 29.17	-28.4 percentage of work productivity loss Standard Deviation 27.11	-29.3 percentage of work productivity loss Standard Deviation 29.38	-30.3 percentage of work productivity loss Standard Deviation 30.73	-32.7 percentage of work productivity loss Standard Deviation 29.65

SECONDARY outcome

Timeframe: Baseline; Weeks 4, 12, and 24

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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=469 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Baseline	61.5 percentage of activity impairment Standard Deviation 22.74	60.5 percentage of activity impairment Standard Deviation 23.85	61.3 percentage of activity impairment Standard Deviation 21.20	62.2 percentage of activity impairment Standard Deviation 22.11	—
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 4	-17.0 percentage of activity impairment Standard Deviation 22.46	-14.7 percentage of activity impairment Standard Deviation 22.07	-14.8 percentage of activity impairment Standard Deviation 23.36	-9.8 percentage of activity impairment Standard Deviation 20.98	—
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 12	-26.5 percentage of activity impairment Standard Deviation 25.17	-24.1 percentage of activity impairment Standard Deviation 24.95	-22.6 percentage of activity impairment Standard Deviation 24.93	-16.9 percentage of activity impairment Standard Deviation 25.98	—
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24 Change from Baseline at Week 24	-30.7 percentage of activity impairment Standard Deviation 26.20	-30.4 percentage of activity impairment Standard Deviation 25.45	-28.6 percentage of activity impairment Standard Deviation 24.99	-21.9 percentage of activity impairment Standard Deviation 27.78	—

SECONDARY outcome

Timeframe: Baseline; Weeks 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: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Filgotinib 200 mg n=472 Participants Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=477 Participants Participants were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks	Adalimumab n=319 Participants Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo n=189 Participants The Placebo arm included all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.	Placebo to Filgotinib 100 mg n=189 Participants Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 Baseline	61.5 percentage of activity impairment Standard Deviation 22.74	60.5 percentage of activity impairment Standard Deviation 23.85	61.3 percentage of activity impairment Standard Deviation 21.20	62.9 percentage of activity impairment Standard Deviation 21.74	59.7 percentage of activity impairment Standard Deviation 22.10
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 Change from Baseline at Week 52	-34.8 percentage of activity impairment Standard Deviation 26.74	-33.7 percentage of activity impairment Standard Deviation 26.44	-32.9 percentage of activity impairment Standard Deviation 26.03	-35.2 percentage of activity impairment Standard Deviation 28.00	-30.8 percentage of activity impairment Standard Deviation 25.99
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52 Change from Baseline at Week 36	-32.6 percentage of activity impairment Standard Deviation 26.66	-31.5 percentage of activity impairment Standard Deviation 25.66	-30.2 percentage of activity impairment Standard Deviation 26.93	-34.9 percentage of activity impairment Standard Deviation 26.60	-27.5 percentage of activity impairment Standard Deviation 26.14

Adverse Events

Filgotinib 200 mg

Serious events: 35 serious events

Other events: 128 other events

Deaths: 3 deaths

Filgotinib 100 mg

Serious events: 40 serious events

Other events: 142 other events

Deaths: 1 deaths

Adalimumab

Serious events: 22 serious events

Other events: 82 other events

Deaths: 1 deaths

Placebo to Filgotinib 200 mg

Serious events: 7 serious events

Other events: 36 other events

Deaths: 1 deaths

Placebo to Filgotinib 100 mg

Serious events: 8 serious events

Other events: 23 other events

Deaths: 1 deaths

Placebo

Serious events: 21 serious events

Other events: 61 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Filgotinib 200 mg n=475 participants at risk Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 participants at risk Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Adalimumab n=325 participants at risk Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo to Filgotinib 200 mg n=190 participants at risk Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo to Filgotinib 100 mg n=191 participants at risk Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo n=475 participants at risk The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
Blood and lymphatic system disorders Anaemia	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Pancytopenia	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Acute myocardial infarction	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Angina unstable	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Cor pulmonale chronic	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Coronary artery disease	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Myocardial infarction	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Meniere's disease	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Cataract	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Macular fibrosis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Eye disorders Vitreous opacities	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Abdominal pain	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Duodenal ulcer perforation	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastrointestinal inflammation	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.42% 2/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Intestinal haemorrhage	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Peptic ulcer	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Gastrointestinal disorders Vomiting	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
General disorders Chest pain	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.42% 2/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Abscess limb	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Appendicitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Arthritis infective	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	0.42% 2/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Candida infection	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Cellulitis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Erysipelas	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Gastroenteritis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Helicobacter infection	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Infected skin ulcer	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Infectious pleural effusion	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Infective tenosynovitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Osteomyelitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Paronychia	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia	0.84% 4/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.83% 4/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.92% 3/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia bacterial	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia fungal	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia pneumococcal	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pneumonia viral	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Pyelonephritis acute	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sepsis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Septic shock	0.42% 2/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 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	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Varicella	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Coronary artery restenosis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Scapula fracture	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Blood creatinine increased	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Lipase increased	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Electrolyte imbalance	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypervitaminosis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Foot deformity	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Limb asymmetry	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage I	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma stage III	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyosarcoma metastatic	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant glioma	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Carotid artery stenosis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Hemiplegia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Ischaemic stroke	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Syncope	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Nervous system disorders Transient ischaemic attack	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.42% 2/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Acute kidney injury	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Prerenal failure	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal cell dysplasia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Prostatitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.42% 2/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Alveolitis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Rheumatoid lung	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Vocal cord polyp	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 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 Angioedema	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 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 Dermatitis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 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 Pustular psoriasis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 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 Skin ulcer	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Deep vein thrombosis	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.31% 1/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.53% 1/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Hypotension	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Vascular disorders Peripheral artery occlusion	0.00% 0/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.00% 0/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.21% 1/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Filgotinib 200 mg n=475 participants at risk Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Filgotinib 100 mg n=480 participants at risk Participants were administered a filgotinib 100 mg tablet orally, once daily + a PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Adalimumab n=325 participants at risk Participants were administered a PTM filgotinib 200 mg tablet orally, once daily + a PTM filgotinib 100 mg tablet orally, once daily + adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	Placebo to Filgotinib 200 mg n=190 participants at risk Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 200 mg and were administered a filgotinib 200 mg tablet orally, once daily + PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo to Filgotinib 100 mg n=191 participants at risk Participants in the placebo arm were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Then the participants in the placebo arm were rerandomized to filgotinib 100 mg and were administered a filgotinib 100 mg tablet orally, once daily + PTM filgotinib 200 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 28.1 weeks.	Placebo n=475 participants at risk The Placebo arm includes all participants who received placebo in the study. Participants were administered a PTM filgotinib 200 mg tablet orally, once daily+ a PTM filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg SC injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or 100 mg groups.
Gastrointestinal disorders Nausea	5.5% 26/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.3% 16/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.8% 6/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.1% 4/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	0.52% 1/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.5% 7/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	9.1% 43/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.0% 48/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	7.4% 24/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 7/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.1% 6/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.3% 25/475 • First dose date up to last dose date (Maximum: 54 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	8.6% 41/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	10.2% 49/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.5% 21/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.2% 8/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.1% 6/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.9% 14/475 • First dose date up to last dose date (Maximum: 54 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	3.8% 18/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.0% 19/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.2% 17/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.3% 10/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.2% 8/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.3% 6/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Alanine aminotransferase increased	3.6% 17/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.2% 25/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	6.5% 21/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	3.7% 7/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.6% 3/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	2.3% 11/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	2.5% 12/475 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.2% 20/480 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	5.2% 17/325 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	4.2% 8/190 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.6% 3/191 • First dose date up to last dose date (Maximum: 54 weeks) plus 30 days The Safety Analysis Set included all participants who received at least 1 dose of study drug.	1.9% 9/475 • First dose date up to last dose date (Maximum: 54 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