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Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (FINCH 3)

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ClinicalTrials.gov Identifier: NCT02886728
Recruitment Status : Completed
First Posted : September 1, 2016
Results First Posted : January 15, 2021
Last Update Posted : June 1, 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: MTX
Drug: Placebo to match MTX
Enrollment 1252
Recruitment Details Participants were enrolled at study sites in Asia, Africa, Australia, Europe, North America, and South America. The first participant was screened on 08 August 2016. The last study visit occurred on 08 May 2019.
Pre-assignment Details 1855 participants were screened.
Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Period Title: Overall Study
Started 417 207 210 418
Completed 345 175 174 331
Not Completed 72 32 36 87
Reason Not Completed
Withdrew Consent             31             13             11             47
Lost to Follow-up             12             6             13             12
Adverse Event             13             5             5             11
Investigator's Discretion             11             7             5             11
Death             3             1             0             0
Protocol Violation             0             0             0             4
Non-Compliance with Study Drug             1             0             1             0
Pregnancy             0             0             1             0
Randomized but Not Dosed             1             0             0             2
Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy Total
Hide Arm/Group Description Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks. Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks. Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks. Total of all reporting groups
Overall Number of Baseline Participants 416 207 210 416 1249
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 416 participants 207 participants 210 participants 416 participants 1249 participants
53  (13.8) 54  (12.6) 52  (13.9) 53  (13.7) 53  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 207 participants 210 participants 416 participants 1249 participants
Female 325 158 166 312 961
Male 91 49 44 104 288
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 416 participants 207 participants 210 participants 416 participants 1249 participants
American Indian or Alaska Native 26 12 18 33 89
Asian: Japanese 23 11 12 25 71
Asian: Chinese/Taiwanese/Hong Kong Chinese 7 4 6 10 27
Asian: Vietnamese 1 0 0 0 1
Asian: Korean 6 8 2 8 24
Asian: Other 53 28 27 42 150
Black or African American 15 8 8 14 45
Native Hawaiian or Pacific Islander 1 0 1 3 5
White 278 132 135 278 823
Other 6 4 0 3 13
Not Permitted 0 0 1 0 1
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 416 participants 207 participants 210 participants 416 participants 1249 participants
Hispanic or Latino 93 40 45 84 262
Not Hispanic or Latino 322 167 165 332 986
Not Permitted 1 0 0 0 1
[1]
Measure Description: Not Permitted = local regulators did not allow collection of race or ethnicity information.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 416 participants 207 participants 210 participants 416 participants 1249 participants
United States 112 47 54 106 319
Spain 12 5 7 10 34
Germany 7 7 6 10 30
South Korea 6 8 2 8 24
Canada 5 5 4 6 20
Belgium 3 2 6 8 19
South Africa 8 5 1 5 19
Australia 7 2 2 7 18
New Zealand 9 3 0 4 16
United Kingdom 1 1 1 5 8
Italy 2 0 1 0 3
Ireland 1 0 0 1 2
Israel 0 0 2 0 2
India 41 21 22 31 115
Poland 35 21 15 37 108
Ukraine 21 10 13 25 69
Bulgaria 17 11 8 18 54
Russia 9 4 4 14 31
Czechia 5 3 3 9 20
Hungary 7 2 3 6 18
Serbia 6 2 4 4 16
Romania 4 1 2 3 10
Slovakia 4 0 2 2 8
Mexico 35 20 23 38 116
Argentina 16 5 4 15 40
Chile 7 3 1 3 14
Taiwan 7 2 5 9 23
Thailand 5 2 1 5 13
Malaysia 1 3 1 1 6
Hong Kong 0 1 1 1 3
Japan 23 11 12 25 71
1.Primary Outcome
Title Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24
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); subject's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain); health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Time Frame Week 24
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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.0
(77.1 to 84.9)
80.2
(74.5 to 85.9)
78.1
(72.3 to 83.9)
71.4
(66.9 to 75.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 9.6
Confidence Interval (2-Sided) 95%
3.6 to 15.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
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 8.8
Confidence Interval (2-Sided) 95%
1.5 to 16.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
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 6.7
Confidence Interval (2-Sided) 95%
-0.7 to 14.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 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 0-3 [0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices]. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled)] when 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 414 participants 207 participants 210 participants 416 participants
1.52  (0.622) 1.56  (0.654) 1.56  (0.655) 1.60  (0.625)
Change at Week 24 Number Analyzed 372 participants 190 participants 185 participants 370 participants
-0.94  (0.722) -0.90  (0.675) -0.89  (0.631) -0.79  (0.634)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 24. 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 MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.19
Confidence Interval (2-Sided) 95%
-0.27 to -0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.041
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 0.009
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 -0.13
Confidence Interval (2-Sided) 95%
-0.23 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.049
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 0.032
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 -0.11
Confidence Interval (2-Sided) 95%
-0.20 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
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 24
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), Patient's Global Assessment of Disease Activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title Filgotinib 200 mg + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.1
(49.2 to 59.0)
42.5
(35.5 to 49.5)
42.4
(35.5 to 49.3)
29.1
(24.6 to 33.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 25.0
Confidence Interval (2-Sided) 95%
18.3 to 31.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 13.4
Confidence Interval (2-Sided) 95%
5.0 to 21.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 13.3
Confidence Interval (2-Sided) 95%
5.0 to 21.6
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the 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 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 410 participants 204 participants 204 participants 408 participants
11.35  (19.922) 13.31  (26.980) 16.53  (32.372) 13.72  (29.168)
Change at Week 24 Number Analyzed 355 participants 184 participants 173 participants 356 participants
0.21  (1.684) 0.22  (1.526) -0.04  (1.710) 0.51  (2.887)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 0.068
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 -0.29
Confidence Interval (2-Sided) 95%
-0.61 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.161
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 0.14
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 -0.29
Confidence Interval (2-Sided) 95%
-0.67 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.195
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 0.006
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 -0.55
Confidence Interval (2-Sided) 95%
-0.94 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.199
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
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 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 414 participants 207 participants 208 participants 416 participants
33.9  (7.48) 33.7  (8.00) 33.6  (7.70) 33.3  (7.28)
Change at Week 24 Number Analyzed 373 participants 190 participants 185 participants 371 participants
12.3  (8.89) 11.1  (9.00) 10.4  (9.09) 9.7  (8.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 2.9
Confidence Interval (2-Sided) 95%
1.8 to 4.0
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 + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 0.021
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 1.6
Confidence Interval (2-Sided) 95%
0.2 to 2.9
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 0.24
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 0.8
Confidence Interval (2-Sided) 95%
-0.5 to 2.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.69
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
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 52. Positive change in value indicates improvement (no or less severity of fatigue).
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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 411 participants 207 participants 206 participants 415 participants
28.3  (10.93) 27.3  (11.92) 27.3  (10.90) 27.1  (10.72)
Change at Week 24 Number Analyzed 365 participants 189 participants 181 participants 365 participants
10.6  (11.49) 11.4  (11.26) 10.2  (11.37) 10.1  (11.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 0.056
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 1.3
Confidence Interval (2-Sided) 95%
-0.0 to 2.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 0.10
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 1.3
Confidence Interval (2-Sided) 95%
-0.3 to 3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.82
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 0.67
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 0.4
Confidence Interval (2-Sided) 95%
-1.3 to 2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.83
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the mTSS at Week 52
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 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Time Frame Baseline; Week 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 411 participants 205 participants 204 participants 408 participants
11.31  (19.273) 12.76  (24.363) 15.89  (31.813) 13.36  (27.736)
Change at Week 52 Number Analyzed 345 participants 176 participants 166 participants 330 participants
0.31  (1.808) 0.23  (1.111) 0.33  (1.902) 0.81  (3.089)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. 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, campaign groups, 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 -0.65
Confidence Interval (2-Sided) 95%
-1.03 to -0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.195
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. 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 0.008
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, 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 -0.63
Confidence Interval (2-Sided) 95%
-1.09 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.236
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. 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 0.006
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, campaign groups, 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 -0.66
Confidence Interval (2-Sided) 95%
-1.14 to -0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.242
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 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 2, 4, 12, 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
42.1
(37.2 to 46.9)
37.2
(30.4 to 44.0)
39.5
(32.7 to 46.4)
16.6
(12.9 to 20.3)
Week 4
62.3
(57.5 to 67.0)
55.6
(48.5 to 62.6)
52.4
(45.4 to 59.4)
33.4
(28.8 to 38.1)
Week 12
76.7
(72.5 to 80.9)
72.0
(65.6 to 78.3)
71.4
(65.1 to 77.8)
59.4
(54.5 to 64.2)
Week 36
75.5
(71.2 to 79.7)
73.4
(67.2 to 79.7)
76.2
(70.2 to 82.2)
68.3
(63.7 to 72.9)
Week 52
75.0
(70.7 to 79.3)
73.4
(67.2 to 79.7)
74.8
(68.6 to 80.9)
61.8
(57.0 to 66.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 25.5
Confidence Interval (2-Sided) 95%
19.3 to 31.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 20.6
Confidence Interval (2-Sided) 95%
12.8 to 28.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 22.9
Confidence Interval (2-Sided) 95%
15.1 to 30.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 28.8
Confidence Interval (2-Sided) 95%
22.1 to 35.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 22.1
Confidence Interval (2-Sided) 95%
13.6 to 30.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 19.0
Confidence Interval (2-Sided) 95%
10.5 to 27.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 17.3
Confidence Interval (2-Sided) 95%
10.8 to 23.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
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%
4.5 to 20.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 12
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
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 12.1
Confidence Interval (2-Sided) 95%
4.0 to 20.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
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 7.2
Confidence Interval (2-Sided) 95%
0.9 to 13.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
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 5.2
Confidence Interval (2-Sided) 95%
-2.7 to 13.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
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 7.9
Confidence Interval (2-Sided) 95%
0.3 to 15.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
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 13.2
Confidence Interval (2-Sided) 95%
6.7 to 19.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
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 11.7
Confidence Interval (2-Sided) 95%
3.7 to 19.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
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 13.0
Confidence Interval (2-Sided) 95%
5.1 to 20.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 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 2, 4, 12, 24, 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
13.0
(9.6 to 16.3)
9.2
(5.0 to 13.4)
16.2
(11.0 to 21.4)
2.9
(1.2 to 4.6)
Week 4
29.3
(24.8 to 33.8)
20.8
(15.0 to 26.5)
25.7
(19.6 to 31.9)
9.4
(6.5 to 12.3)
Week 12
53.1
(48.2 to 58.0)
44.4
(37.4 to 51.5)
45.7
(38.7 to 52.7)
28.4
(23.9 to 32.8)
Week 24
61.5
(56.7 to 66.3)
57.0
(50.0 to 64.0)
58.1
(51.2 to 65.0)
45.7
(40.8 to 50.6)
Week 36
60.6
(55.8 to 65.4)
55.6
(48.5 to 62.6)
58.6
(51.7 to 65.5)
48.6
(43.6 to 53.5)
Week 52
62.3
(57.5 to 67.0)
59.4
(52.5 to 66.4)
61.4
(54.6 to 68.3)
48.3
(43.4 to 53.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 10.1
Confidence Interval (2-Sided) 95%
6.2 to 13.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 6.3
Confidence Interval (2-Sided) 95%
1.7 to 10.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 13.3
Confidence Interval (2-Sided) 95%
7.7 to 18.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 20.0
Confidence Interval (2-Sided) 95%
14.5 to 25.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 11.4
Confidence Interval (2-Sided) 95%
4.8 to 18.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 16.3
Confidence Interval (2-Sided) 95%
9.4 to 23.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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%
18.1 to 31.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 16.1
Confidence Interval (2-Sided) 95%
7.7 to 24.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 17.3
Confidence Interval (2-Sided) 95%
9.0 to 25.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 15.9
Confidence Interval (2-Sided) 95%
8.9 to 22.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
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 11.3
Confidence Interval (2-Sided) 95%
2.7 to 20.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 24
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
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 12.4
Confidence Interval (2-Sided) 95%
3.9 to 21.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
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 12.0
Confidence Interval (2-Sided) 95%
5.1 to 19.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.090
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%
-1.7 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
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 10.0
Confidence Interval (2-Sided) 95%
1.4 to 18.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
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 13.9
Confidence Interval (2-Sided) 95%
7.0 to 20.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
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 11.1
Confidence Interval (2-Sided) 95%
2.5 to 19.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
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 13.1
Confidence Interval (2-Sided) 95%
4.6 to 21.6
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 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 2, 4, 12, 24, 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
3.1
(1.3 to 4.9)
1.9
(0.0 to 4.0)
4.3
(1.3 to 7.3)
0.7
(0.0 to 1.7)
Week 4
13.0
(9.6 to 16.3)
6.3
(2.7 to 9.8)
11.4
(6.9 to 16.0)
3.8
(1.9 to 5.8)
Week 12
32.9
(28.3 to 37.6)
27.1
(20.8 to 33.3)
29.0
(22.7 to 35.4)
13.2
(9.8 to 16.6)
Week 24
43.8
(38.9 to 48.6)
40.1
(33.2 to 47.0)
40.0
(33.1 to 46.9)
26.0
(21.6 to 30.3)
Week 36
45.9
(41.0 to 50.8)
37.2
(30.4 to 44.0)
39.5
(32.7 to 46.4)
32.2
(27.6 to 36.8)
Week 52
47.8
(42.9 to 52.8)
40.1
(33.2 to 47.0)
45.2
(38.3 to 52.2)
29.8
(25.3 to 34.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
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 2.4
Confidence Interval (2-Sided) 95%
0.3 to 4.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
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 1.2
Confidence Interval (2-Sided) 95%
-1.2 to 3.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 2
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
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 3.6
Confidence Interval (2-Sided) 95%
0.3 to 6.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 9.1
Confidence Interval (2-Sided) 95%
5.2 to 13.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 4
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 2.4
Confidence Interval (2-Sided) 95%
-1.7 to 6.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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%
2.5 to 12.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 19.7
Confidence Interval (2-Sided) 95%
13.9 to 25.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 13.8
Confidence Interval (2-Sided) 95%
6.6 to 21.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 15.8
Confidence Interval (2-Sided) 95%
8.5 to 23.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 17.8
Confidence Interval (2-Sided) 95%
11.2 to 24.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 14.1
Confidence Interval (2-Sided) 95%
5.9 to 22.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 14.0
Confidence Interval (2-Sided) 95%
5.8 to 22.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36
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 13.7
Confidence Interval (2-Sided) 95%
6.9 to 20.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
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 5.0
Confidence Interval (2-Sided) 95%
-3.3 to 13.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
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 7.3
Confidence Interval (2-Sided) 95%
-1.0 to 15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52
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 18.0
Confidence Interval (2-Sided) 95%
11.3 to 24.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
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 10.3
Confidence Interval (2-Sided) 95%
1.9 to 18.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52
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%
7.0 to 23.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 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 (less disability).
Time Frame Baseline; Weeks 2, 4, 12, 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 414 participants 207 participants 210 participants 416 participants
1.52  (0.622) 1.56  (0.654) 1.56  (0.655) 1.60  (0.625)
Change at Week 2 Number Analyzed 400 participants 202 participants 202 participants 405 participants
-0.37  (0.495) -0.36  (0.490) -0.32  (0.442) -0.18  (0.426)
Change at Week 4 Number Analyzed 405 participants 200 participants 205 participants 403 participants
-0.57  (0.587) -0.45  (0.547) -0.51  (0.526) -0.32  (0.511)
Change at Week 12 Number Analyzed 389 participants 197 participants 193 participants 389 participants
-0.85  (0.698) -0.77  (0.670) -0.76  (0.625) -0.61  (0.582)
Change at Week 36 Number Analyzed 348 participants 178 participants 179 participants 327 participants
-0.96  (0.725) -0.93  (0.700) -0.91  (0.673) -0.89  (0.675)
Change at Week 52 Number Analyzed 332 participants 169 participants 171 participants 307 participants
-1.00  (0.728) -0.97  (0.719) -0.95  (0.688) -0.88  (0.685)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.29 to -0.17
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.031
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.28 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 subjects 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 -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.29
Confidence Interval (2-Sided) 95%
-0.35 to -0.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.035
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-0.23 to -0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.21
Confidence Interval (2-Sided) 95%
-0.29 to -0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.042
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.35 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.039
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.28 to -0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 subjects 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%
-0.26 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.048
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. 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 subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.22 to -0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.043
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. 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 0.23
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.17 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. 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 0.24
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.16 to 0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.052
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 52. 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 subjects 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%
-0.25 to -0.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 52. 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 0.077
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects 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%
-0.20 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 52. 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 0.039
Comments MMRM model included treatment, visit, treatment by visit, stratification factors, and baseline value as fixed effects, and subjects being the random effect.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.22 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.054
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 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 2, 4, 12, 24, 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 + MTX Filgotinib 100 mg + MTX Filgotinib 200 mg Monotherapy MTX Monotherapy
Hide Arm/Group Description:
Participants were administered filgotinib 200 mg orally, once daily + placebo to match (PTM) filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 100 mg orally, once daily + PTM filgotinib 200 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 54 weeks.
Participants were administered filgotinib 200 mg orally, once daily + PTM filgotinib 100 mg orally, once daily + PTM MTX orally, once weekly for up to 54 weeks.
Participants were administered PTM filgotinib 200 mg orally, once daily+ PTM filgotinib 100 mg orally, once daily + MTX up to 20 mg orally, once weekly for up to 56 weeks.
Overall Number of Participants Analyzed 416 207 210 416
Mean (Standard Deviation)
Unit of Measure: tender joint count
Baseline Number Analyzed 416 participants 207 participants 210 participants 416 participants
26  (14.5) 25  (13.9) 26  (13.7) 26  (13.8)
Change at Week 2 Number Analyzed 402 participants 202 participants 201 participants 405 participants
-9  (10.2) -8  (9.8) -9  (11.2) -5  (9.8)
Change at Week 4 Number Analyzed 408 participants 201 participants 205 participants 404 participants
-13  (12.1) -12  (10.1) -13  (11.8) -8  (11.5)
Change at Week 12 Number Analyzed 390 participants 197 participants 193 participants 387 participants
-18  (12.5) -17  (12.4) -18  (12.4) -15  (12.2)
Change at Week 24 Number Analyzed 374 participants 190 participants 186 participants 370 participants
-20  (12.5) -20  (13.0) -22  (12.4) -19  (12.9)
Change at Week 36 Number Analyzed 348 participants 178 participants 179 participants 327 participants
-21  (12.6) -21  (12.8) -23  (11.9) -21  (12.7)
Change at Week 52 Number Analyzed 332 participants 170 participants 171 participants 307 participants
-22  (12.4) -21  (13.0) -23  (12.3) -21  (12.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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%
-6.0 to -3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 -4.0
Confidence Interval (2-Sided) 95%
-6.0 to -2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 -3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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 -4.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 -4.0
Confidence Interval (2-Sided) 95%
-6.0 to -3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 -3.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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%
-5.0 to -2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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%
-5.0 to -2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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%
-6.0 to -2.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy 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]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy 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 0.005
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: 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy 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 -1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg + MTX, MTX Monotherapy
Comments Filgotinib 200 mg + MTX vs MTX Monotherapy at Week 36. 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 0.063
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: 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Filgotinib 100 mg + MTX, MTX Monotherapy
Comments Filgotinib 100 mg + MTX vs MTX Monotherapy at Week 36. 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 0.64
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 0.0
Confidence Interval (2-Sided) 95%
-1.0 to 1.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Filgotinib 200 mg Monotherapy, MTX Monotherapy
Comments Filgotinib 200 mg Monotherapy vs MTX Monotherapy at Week 36. 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]