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

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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:
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
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
Hide 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
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo Total
Hide 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
Hide 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
1.Primary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg Filgotinib 100 mg Adalimumab Placebo
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]