Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (FINCH 1)

• ClinicalTrials.gov Identifier: NCT02889796
• Recruitment Status: Completed
• First Posted: September 7, 2016
• Results First Posted: January 19, 2021
• Last Update Posted: June 9, 2021
• Sponsor: Gilead Sciences
• Collaborator: Galapagos NV
• Information provided by (Responsible Party): Gilead Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis
• Interventions: Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: Adalimumab; Drug: Placebo to match adalimumab; Drug: MTX
• Enrollment: 1759

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Asia, South Africa, Australia, Europe, North America, South America, and New Zealand. The first participant was screened on 30 August 2016. The last study visit occurred on 20 June 2019.
Pre-assignment Details	2582 participants were screened.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg	Placebo Never Received Filgotinib
Arm/Group Description	Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.	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.
Period Title: Overall Study
Started	477	480	325	190	191	96
Completed	424	422	281	181	185	24 [1]
Not Completed	53	58	44	9	6	72
Reason Not Completed
Withdrew Consent	18	29	20	1	2	35
Investigator's Discretion	10	9	10	3	0	15
Adverse Event	17	8	8	4	1	7
Lost to Follow-up	5	7	2	0	2	6
Protocol Violation	0	1	3	0	0	4
Non-compliance With Study Drug	0	2	0	0	1	2
Death	1	1	0	1	0	1
Pregnancy	0	1	1	0	0	0
Randomized but not Dosed	2	0	0	0	0	2
[1] Completed 24 weeks of placebo treatment and not rerandomized to Filgotinib 200 mg or 100 mg groups

Baseline Characteristics

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

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Description	ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of methotrexate (MTX), orally for median exposure of up to 52.1 weeks.	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	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.	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.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	76.6; (72.7 to 80.5)	69.8; (65.6 to 74.0)	70.5; (65.3 to 75.6)	49.9; (45.3 to 54.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	26.7
	Confidence Interval	(2-Sided) 95%; 20.6 to 32.8
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.9
	Confidence Interval	(2-Sided) 95%; 13.6 to 26.2
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). 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).
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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	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.	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.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.63 (0.613)
Change from Baseline at Week 12	Number Analyzed	457 participants	459 participants	311 participants	435 participants
		-0.69 (0.613)	-0.56 (0.564)	-0.61 (0.560)	-0.42 (0.544)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from mixed effects model for repeated measures (MMRM). Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	Mixed effects model for repeated measure
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.36 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.034
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.24 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.034
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
Description	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (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.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	34.1; (29.7 to 38.5)	23.8; (19.8 to 27.7)	23.7; (18.9 to 28.5)	9.3; (6.6 to 12.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	24.8
	Confidence Interval	(2-Sided) 95%; 19.6 to 30.0
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 95%; 9.7 to 19.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 using non-responder imputation (NRI).
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) < 2.6 using NRI.
Statistical Test of Hypothesis	P-Value	0.002
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	10.4
	Confidence Interval	(2-Sided) 95%; 3.9 to 17.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.99
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -6.2 to 6.3
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Description	Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating 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).
Time Frame	Baseline; Week 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		467	471	319	466
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	467 participants	471 participants	319 participants	466 participants
		32.47 (47.939)	36.70 (53.065)	34.82 (55.013)	31.60 (53.217)
Change from Baseline at Week 24	Number Analyzed	405 participants	404 participants	271 participants	351 participants
		0.13 (0.937)	0.17 (0.905)	0.16 (0.948)	0.37 (1.417)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.43 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.078
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.078
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12
Description	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	49.7; (45.1 to 54.3)	38.8; (34.3 to 43.2)	43.4; (37.8 to 48.9)	23.4; (19.5 to 27.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	26.3
	Confidence Interval	(2-Sided) 95%; 20.2 to 32.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	15.4
	Confidence Interval	(2-Sided) 95%; 9.4 to 21.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12
	Type of Statistical Test	Non-Inferiority
	Comments	For non-inferiority test, the approach proposed by Liu 2014 was used to demonstrate that each filgotinib dose preserves more than 50% of the effect of adalimumab on the response rate of DAS28 (CRP) ≤ 3.2 using NRI.
Statistical Test of Hypothesis	P-Value	0.054
	Comments	P-value of non-inferiority test was calculated from approach proposed by [Liu 2014].
	Method	Method proposed by [Liu 2014]
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Adalimumab
	Comments	Filgotinib 200 mg vs Adalimumab at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.069
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	6.3
	Confidence Interval	(2-Sided) 95%; -1.0 to 13.6
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Adalimumab
	Comments	Filgotinib 100 mg vs Adalimumab at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	-4.6
	Confidence Interval	(2-Sided) 95%; -11.8 to 2.6
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Description	The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		473	479	323	474
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	473 participants	479 participants	323 participants	474 participants
		33.4 (7.17)	33.6 (7.75)	32.8 (7.74)	32.9 (7.11)
Change from Baseline at Week 12	Number Analyzed	459 participants	463 participants	310 participants	440 participants
		9.2 (8.10)	8.5 (7.72)	8.4 (7.89)	5.8 (7.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; 2.8 to 4.6
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.47
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; 2.2 to 4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.46
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
Description	FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Time Frame	Baseline; Week 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		472	477	319	469
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	472 participants	477 participants	319 participants	469 participants
		27.6 (10.68)	27.8 (10.60)	27.2 (10.20)	26.9 (10.34)
Change from Baseline at Week 12	Number Analyzed	452 participants	455 participants	304 participants	432 participants
		9.2 (9.82)	9.1 (10.15)	8.8 (9.19)	6.8 (9.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.8
	Confidence Interval	(2-Sided) 95%; 1.7 to 3.9
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.56
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; 1.5 to 3.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.55
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
Description	ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	9.1; (6.4 to 11.7)	5.8; (3.6 to 8.0)	6.8; (3.9 to 9.7)	1.1; (0.0 to 2.1)
Week 4	22.3; (18.5 to 26.2)	12.9; (9.8 to 16.0)	17.2; (13.0 to 21.5)	5.9; (3.7 to 8.1)
Week 12	47.2; (42.6 to 51.8)	36.5; (32.0 to 40.9)	35.1; (29.7 to 40.4)	19.8; (16.1 to 23.5)
Week 24	57.9; (53.3 to 62.4)	52.7; (48.1 to 57.3)	52.3; (46.7 to 57.9)	33.3; (28.9 to 37.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	8.0
	Confidence Interval	(2-Sided) 95%; 5.1 to 10.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	4.8
	Confidence Interval	(2-Sided) 95%; 2.3 to 7.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.4
	Confidence Interval	(2-Sided) 95%; 11.9 to 20.9
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; 3.1 to 10.9
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	27.4
	Confidence Interval	(2-Sided) 95%; 21.4 to 33.3
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	16.7
	Confidence Interval	(2-Sided) 95%; 10.9 to 22.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	24.6
	Confidence Interval	(2-Sided) 95%; 18.3 to 31.0
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.4
	Confidence Interval	(2-Sided) 95%; 13.1 to 25.8
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
Description	ACR50 response is achieved when the participant has: ≥50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	63.2; (58.7 to 67.6)	57.7; (53.2 to 62.2)	57.5; (52.0 to 63.1)	67.9; (61.0 to 74.8)	63.4; (56.3 to 70.4)
Week 52	64.2; (59.8 to 68.6)	60.6; (56.2 to 65.1)	62.2; (56.7 to 67.6)	68.4; (61.5 to 75.3)	66.0; (59.0 to 72.9)

10. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
Description	ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	2.7; (1.2 to 4.3)	1.3; (0.2 to 2.3)	0.9; (0.0 to 2.1)	0.4; (0.0 to 1.1)
Week 4	9.1; (6.4 to 11.7)	3.3; (1.6 to 5.0)	3.7; (1.5 to 5.9)	1.5; (0.3 to 2.7)
Week 12	26.1; (22.1 to 30.2)	18.5; (15.0 to 22.1)	14.2; (10.2 to 18.1)	6.7; (4.4 to 9.1)
Week 24	36.2; (31.8 to 40.6)	29.6; (25.4 to 33.8)	29.5; (24.4 to 34.7)	14.9; (11.6 to 18.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.5 to 4.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	0.8
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	7.6
	Confidence Interval	(2-Sided) 95%; 4.6 to 10.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.067
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -0.3 to 4.0
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.4
	Confidence Interval	(2-Sided) 95%; 14.6 to 24.1
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	11.8
	Confidence Interval	(2-Sided) 95%; 7.5 to 16.2
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	21.3
	Confidence Interval	(2-Sided) 95.0%; 15.7 to 26.9
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	14.6
	Confidence Interval	(2-Sided) 95%; 9.2 to 20.0
	Estimation Comments	[Not Specified]

11. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
Description	ACR70 response is achieved when the participant has: ≥70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	40.2; (35.7 to 44.7)	35.4; (31.0 to 39.8)	32.9; (27.7 to 38.2)	44.7; (37.4 to 52.1)	34.6; (27.5 to 41.6)
Week 52	44.4; (39.8 to 49.0)	39.0; (34.5 to 43.4)	41.2; (35.7 to 46.7)	48.4; (41.1 to 55.8)	37.7; (30.6 to 44.8)

12. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
Description	ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 2, 4, and 24

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed	475	480	325	475
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 2	37.3; (32.8 to 41.7)	27.5; (23.4 to 31.6)	33.5; (28.3 to 38.8)	14.9; (11.6 to 18.3)
Week 4	51.6; (47.0 to 56.2)	45.6; (41.1 to 50.2)	47.1; (41.5 to 52.7)	31.8; (27.5 to 36.1)
Week 24	78.1; (74.3 to 81.9)	77.7; (73.9 to 81.5)	74.5; (69.6 to 79.4)	59.2; (54.6 to 63.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	22.3
	Confidence Interval	(2-Sided) 95%; 16.7 to 27.9
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	12.6
	Confidence Interval	(2-Sided) 95%; 7.2 to 17.9
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	19.8
	Confidence Interval	(2-Sided) 95%; 13.4 to 26.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	13.8
	Confidence Interval	(2-Sided) 95%; 7.5 to 20.2
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.9
	Confidence Interval	(2-Sided) 95%; 13.0 to 24.9
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	P-value was calculated from the logistic regression with treatment groups and stratification factors in the model.
	Method	Regression, Logistic
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in Response Rates
	Estimated Value	18.6
	Confidence Interval	(2-Sided) 95%; 12.6 to 24.5
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
Description	ACR20 response is achieved when the participant has: ≥20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
Time Frame	Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:	Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed	475	480	325	190	191
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Week 36	82.9; (79.5 to 86.4)	79.2; (75.4 to 82.9)	76.3; (71.5 to 81.1)	90.5; (86.1 to 95.0)	86.9; (81.9 to 92.0)
Week 52	82.9; (79.5 to 86.4)	79.6; (75.9 to 83.3)	77.8; (73.2 to 82.5)	86.3; (81.2 to 91.5)	85.9; (80.7 to 91.1)

14. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.63 (0.613)
Change from Baseline at Week 2	Number Analyzed	463 participants	474 participants	317 participants	466 participants
		-0.30 (0.443)	-0.22 (0.406)	-0.29 (0.440)	-0.15 (0.357)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-0.43 (0.493)	-0.33 (0.454)	-0.40 (0.460)	-0.26 (0.431)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	376 participants
		-0.82 (0.632)	-0.75 (0.597)	-0.78 (0.632)	-0.62 (0.598)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.22 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.09
	Confidence Interval	(2-Sided) 95%; -0.14 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.025
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.24 to -0.13
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.028
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 95%; -0.15 to -0.04
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.028
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 95%; -0.34 to -0.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.037
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 95%; -0.26 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.037
	Estimation Comments	[Not Specified]

15. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
Description	The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		1.59 (0.611)	1.55 (0.625)	1.59 (0.600)	1.68 (0.578)	1.58 (0.603)
Change from Baseline at Week 36	Number Analyzed	412 participants	417 participants	275 participants	180 participants	188 participants
		-0.88 (0.633)	-0.80 (0.611)	-0.81 (0.634)	-0.96 (0.637)	-0.69 (0.610)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-0.93 (0.649)	-0.85 (0.621)	-0.85 (0.647)	-0.99 (0.644)	-0.73 (0.650)

16. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
Description	TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: tender joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		25 (13.5)	25 (13.4)	24 (13.2)	24 (13.5)
Change from Baseline at Week 2	Number Analyzed	464 participants	473 participants	317 participants	464 participants
		-8 (10.1)	-7 (9.3)	-7 (8.8)	-5 (9.0)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-11 (11.1)	-10 (10.3)	-9 (9.2)	-8 (10.5)
Change from Baseline at Week 12	Number Analyzed	458 participants	458 participants	311 participants	435 participants
		-17 (11.1)	-15 (10.7)	-15 (9.9)	-13 (11.6)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	375 participants
		-20 (12.1)	-19 (10.9)	-18 (11.1)	-17 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3
	Confidence Interval	(2-Sided) 95%; -4.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-4.0
	Confidence Interval	(2-Sided) 95%; -5.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.6
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.5
	Estimation Comments	[Not Specified]

17. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
Description	TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: tender joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		25 (13.5)	25 (13.4)	24 (13.2)	25 (12.8)	24 (12.9)
Change from Baseline at Week 36	Number Analyzed	411 participants	417 participants	275 participants	178 participants	188 participants
		-21 (11.9)	-20 (11.2)	-19 (11.0)	-21 (11.4)	-19 (11.5)
Change from Baseline at Week 52	Number Analyzed	400 participants	397 participants	265 participants	173 participants	177 participants
		-21 (12.2)	-21 (11.4)	-20 (11.4)	-21 (11.9)	-20 (11.2)

18. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
Description	The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: swollen joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		15 (8.5)	15 (8.5)	16 (8.4)	16 (8.5)
Change from Baseline at Week 2	Number Analyzed	464 participants	473 participants	317 participants	464 participants
		-6 (6.7)	-5 (6.8)	-6 (5.8)	-5 (6.9)
Change from Baseline at Week 4	Number Analyzed	469 participants	471 participants	320 participants	461 participants
		-8 (7.1)	-8 (7.8)	-7 (6.6)	-6 (7.8)
Change from Baseline at Week 12	Number Analyzed	458 participants	458 participants	311 participants	435 participants
		-11 (7.5)	-11 (8.1)	-11 (7.1)	-10 (8.4)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	375 participants
		-13 (7.8)	-13 (7.4)	-13 (6.9)	-12 (7.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.047
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -0.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -3.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-1.0
	Confidence Interval	(2-Sided) 95.0%; -2.0 to -1.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.3
	Estimation Comments	[Not Specified]

19. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
Description	The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: swollen joint count
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		15 (8.5)	15 (8.5)	16 (8.4)	16 (8.2)	15 (7.9)
Change from Baseline at Week 36	Number Analyzed	411 participants	417 participants	275 participants	178 participants	188 participants
		-14 (7.8)	-13 (7.6)	-14 (7.1)	-14 (7.3)	-13 (7.2)
Change from Baseline at Week 52	Number Analyzed	400 participants	397 participants	265 participants	173 participants	177 participants
		-14 (8.1)	-13 (7.6)	-14 (7.5)	-14 (7.8)	-13 (7.4)

20. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
Description	SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks.. Participants could be rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		67 (19.2)	65 (19.7)	67 (19.1)	68 (18.7)
Change from Baseline at Week 2	Number Analyzed	464 participants	474 participants	318 participants	466 participants
		-16 (20.1)	-11 (18.4)	-13 (18.1)	-8 (17.2)
Change from Baseline at Week 4	Number Analyzed	469 participants	472 participants	319 participants	461 participants
		-22 (21.5)	-16 (20.8)	-19 (20.8)	-13 (20.2)
Change from Baseline at Week 12	Number Analyzed	457 participants	458 participants	311 participants	435 participants
		-33 (24.8)	-28 (24.7)	-28 (23.2)	-21 (24.8)
Change from Baseline at Week 24	Number Analyzed	418 participants	423 participants	283 participants	376 participants
		-39 (25.8)	-36 (24.9)	-36 (24.9)	-31 (26.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-9.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -7.0 to -2.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-13.0
	Confidence Interval	(2-Sided) 95%; -16.0 to -10.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-10.0
	Confidence Interval	(2-Sided) 95%; -12.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-11.0
	Confidence Interval	(2-Sided) 95%; -14.0 to -7.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 24. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6
	Estimation Comments	[Not Specified]

21. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
Description	SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 36, and 52

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo to Filgotinib 200 mg	Placebo to Filgotinib 100 mg
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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.	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.
Overall Number of Participants Analyzed		475	480	325	190	191
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	190 participants	191 participants
		67 (19.2)	65 (19.7)	67 (19.1)	70 (17.8)	66 (18.7)
Change from Baseline at Week 36	Number Analyzed	412 participants	417 participants	274 participants	180 participants	188 participants
		-42 (24.2)	-39 (25.3)	-39 (25.2)	-45 (24.7)	-38 (25.5)
Change from Baseline at Week 52	Number Analyzed	400 participants	398 participants	265 participants	173 participants	177 participants
		-44 (24.4)	-41 (25.4)	-42 (25.7)	-45 (27.6)	-41 (25.3)

22. Secondary Outcome

Title	Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
Description	PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
Time Frame	Baseline; Weeks 2, 4, 12, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Filgotinib 200 mg	Filgotinib 100 mg	Adalimumab	Placebo
Arm/Group Description:		Participants were administered a filgotinib 200 mg tablet orally, once daily + a placebo to match (PTM) filgotinib 100 mg tablet orally, once daily + PTM adalimumab 40 mg subcutaneous (SC) injection, once every 2 weeks in addition to a weekly stable dose of MTX, orally for median exposure of up to 52.1 weeks.	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.	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.	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 up to 24 weeks. Participants were rerandomized to filgotinib 200 mg or filgotinib 100 mg.
Overall Number of Participants Analyzed		475	480	325	475
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	Number Analyzed	475 participants	480 participants	325 participants	475 participants
		66 (16.0)	65 (16.5)	67 (15.5)	66 (16.2)
Change from Baseline at Week 2	Number Analyzed	463 participants	469 participants	315 participants	463 participants
		-20 (19.3)	-18 (18.5)	-19 (17.9)	-13 (17.8)
Change from Baseline at Week 4	Number Analyzed	468 participants	466 participants	318 participants	457 participants
		-28 (21.2)	-26 (19.7)	-26 (19.6)	-20 (19.6)
Change from Baseline at Week 12	Number Analyzed	457 participants	450 participants	308 participants	433 participants
		-41 (20.2)	-39 (20.3)	-39 (20.4)	-34 (22.4)
Change from Baseline at Week 24	Number Analyzed	413 participants	419 participants	283 participants	373 participants
		-48 (19.2)	-46 (19.6)	-47 (19.4)	-42 (20.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 2. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -8.0 to -4.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -11.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 4. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -9.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 200 mg, Placebo
	Comments	Filgotinib 200 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-8.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -6.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Filgotinib 100 mg, Placebo
	Comments	Filgotinib 100 mg vs Placebo at Week 12. LS-Mean, 95% CI, and P-value were provided from MMRM. Missing change scores were not imputed using the MMRM approach assuming an unstructured variance-covariance matrix for the repeated measures.
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and participants being the random effect.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Least Squares Mean Difference
	Estimated Value	-7.0
	Confidence Interval	(2-Sided) 95%; -10.0 to -5.0
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.2
	Estimation Comments	[Not Specified]