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Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)

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ClinicalTrials.gov Identifier: NCT01888874
Recruitment Status : Completed
First Posted : June 28, 2013
Results First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Galapagos NV

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: GLPG0634
Drug: Placebo
Enrollment 599
Recruitment Details Participants were enrolled at study sites in Europe, South America, North America, Australia, and New Zealand. The first participant was screened on 17 July 2013. The last study visit occurred on 14 May 2015.
Pre-assignment Details A total of 1255 participants were screened of which 599 participants were randomized into the study and only 594 participants were treated.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Period Title: Period 1 (Baseline up to Week 12)
Started 86 82 85 86 86 85 84
Completed 83 76 78 80 77 80 83
Not Completed 3 6 7 6 9 5 1
Reason Not Completed
Withdrawal by Subject             2             2             3             4             3             0             0
Other             1             0             1             1             3             3             0
Physician Decision             0             0             0             0             0             0             1
Adverse Event             0             2             3             1             2             1             0
Adverse event and treatment failure             0             0             0             0             1             0             0
Non-compliance with the study procedures             0             1             0             0             0             0             0
Lost to Follow-up             0             1             0             0             0             1             0
Period Title: Period 2 (Week 13 to Week 24)
Started 53 [1] 57 [2] 112 [3] 80 60 [4] 112 [5] 83
Completed 50 55 104 78 57 109 80
Not Completed 3 2 8 2 3 3 3
Reason Not Completed
Withdrawal by Subject             1             1             2             0             1             0             0
Adverse event and treatment failure             0             0             0             0             1             0             0
Non compliance with study medication             0             0             2             0             0             1             0
Treatment failure             0             0             1             0             0             0             0
Adverse Event             2             0             3             2             1             1             3
Lost to Follow-up             0             1             0             0             0             1             0
[1]
Nonresponders from Placebo group moved to 100 mg QD(15 participants) and 50 mg BID(15 participants).
[2]
Nonresponders from 50 mg QD group moved to 100 mg QD group (19 participants).
[3]
Nonresponders from Placebo(15 participants) and 50 mg QD (19 participants) moved to 100 mg QD group.
[4]
Nonresponders from 25 mg BID group moved to 50 mg BID group (17 participants).
[5]
Nonresponders from Placebo(15 participants) and 25 mg BID(17 participants) moved to 50 mg BID group.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID Total
Hide Arm/Group Description Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24. Total of all reporting groups
Overall Number of Baseline Participants 86 82 85 86 86 85 84 594
Hide Baseline Analysis Population Description
Safety population included all participants who were randomized and received at least one dose of study medication.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
52
(18 to 84)
52.8
(20 to 77)
52.3
(20 to 79)
54.8
(19 to 75)
52.4
(24 to 79)
55.4
(21 to 78)
53.9
(22 to 76)
53.4
(18 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
Female
70
  81.4%
69
  84.1%
65
  76.5%
74
  86.0%
68
  79.1%
65
  76.5%
70
  83.3%
481
  81.0%
Male
16
  18.6%
13
  15.9%
20
  23.5%
12
  14.0%
18
  20.9%
20
  23.5%
14
  16.7%
113
  19.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
Hispanic or Latino
37
  43.0%
37
  45.1%
33
  38.8%
33
  38.4%
37
  43.0%
30
  35.3%
38
  45.2%
245
  41.2%
Not Hispanic or Latino
49
  57.0%
45
  54.9%
52
  61.2%
53
  61.6%
49
  57.0%
55
  64.7%
46
  54.8%
349
  58.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
   1.2%
0
   0.0%
0
   0.0%
1
   1.2%
0
   0.0%
2
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.2%
0
   0.0%
0
   0.0%
1
   1.2%
0
   0.0%
0
   0.0%
1
   1.2%
3
   0.5%
White
59
  68.6%
61
  74.4%
62
  72.9%
67
  77.9%
63
  73.3%
65
  76.5%
66
  78.6%
443
  74.6%
More than one race
26
  30.2%
21
  25.6%
22
  25.9%
18
  20.9%
23
  26.7%
19
  22.4%
17
  20.2%
146
  24.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Rheumatoid Arthritis (RA) duration  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
8.21
(0.5 to 36.5)
7.21
(0.6 to 21.3)
7.67
(0.6 to 32.6)
8.51
(0.5 to 34.5)
8.88
(0.5 to 30.1)
7.79
(0.5 to 28.8)
9.74
(0.5 to 43.2)
8.29
(0.5 to 43.2)
C-reactive protein (CRP) at Baseline  
Mean (Full Range)
Unit of measure:  Milligram per liter (mg/L)
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
16.25
(1 to 84.5)
27.71
(1 to 158.7)
24.54
(1 to 140.7)
27.1
(1 to 140.9)
26.01
(1.2 to 157.3)
24.6
(1 to 113.4)
26.86
(1 to 129.4)
24.70
(1 to 158.7)
Corrected tender joint count based on 68 joints (TJC68) at Baseline   [1] 
Mean (Full Range)
Unit of measure:  Joint count
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
24.984
(8 to 60)
24.907
(8 to 64)
25.319
(8 to 68)
28.843
(8 to 68)
25.427
(8 to 64)
27.158
(8 to 66)
25.946
(7 to 61)
26.091
(7 to 68)
[1]
Measure Description: 68 joints were assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Corrected swollen joint count based on 66 joints (SJC66) at Baseline   [1] 
Mean (Full Range)
Unit of measure:  Joint count
Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants 594 participants
16.13
(6 to 48)
17.023
(6 to 66)
16.31
(6 to 54)
17.355
(6 to 58)
15.663
(6 to 40)
17.534
(6 to 62)
16.356
(6 to 48)
16.622
(6 to 66)
[1]
Measure Description: 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
1.Primary Outcome
Title Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12
Hide Description The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used (ie, to impute a missing response, the participant was assumed to be a non-responder).
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants in the safety population who had post-randomization data for at least one efficacy parameter.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
44.2 56.1 63.5 68.6 57 60 78.6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 50 mg QD
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1236
Comments [Not Specified]
Method Regression, Logistic
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 11.9
Confidence Interval (2-Sided) 95%
-3.1 to 26.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 100 mg QD
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0435
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 19.3
Confidence Interval (2-Sided) 95%
4.7 to 34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 200 mg QD
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0068
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 24.4
Confidence Interval (2-Sided) 95%
10.1 to 38.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 25 mg BID
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1236
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 12.8
Confidence Interval (2-Sided) 95%
-2 to 27.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 50 mg BID
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1056
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 15.8
Confidence Interval (2-Sided) 95%
1 to 30.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, GLPG0634 100 mg BID
Comments Pairwise comparisons of each group vs. the placebo group using a logistic regression model with factors treatment group, geographical region, and prior use of biologics.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments P-value has been corrected for multiplicity according to Hommel's closed-testing method.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentage rates
Estimated Value 34.4
Confidence Interval (2-Sided) 95%
20.7 to 48.1
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving an ACR20 Response at Week 24
Hide Description ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
41.9 54.9 61.2 73.3 55.8 60 79.8
3.Secondary Outcome
Title Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Hide Description ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Total HAQ-DI score 5. CRP. Non-responder imputation was used.
Time Frame Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 1.2 2.4 4.7 4.7 3.5 7.1 7.1
Week 2 5.8 7.3 20 10.5 7 11.8 21.4
Week 4 7 13.4 32.9 17.4 15.1 18.8 34.5
Week 8 12.8 26.8 35.3 33.7 25.6 34.1 45.2
Week 12 15.1 32.9 37.6 43 27.9 34.1 54.8
Week 24 16.3 35.4 47.1 50 34.9 35.3 54.8
4.Secondary Outcome
Title Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
Hide Description ACR70 response: 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.
Time Frame Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 1.2 0 0 1.2 1.2 2.4 4.8
Week 2 1.2 2.4 7.1 5.8 2.3 5.9 3.6
Week 4 3.5 7.3 14.1 4.7 5.8 9.4 10.7
Week 8 7 11 23.5 18.6 9.3 14.1 27.4
Week 12 8.1 15.9 21.2 24.4 14 18.8 31
Week 24 9.3 22 32.9 29.1 20.9 23.5 39.3
5.Secondary Outcome
Title ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
Hide Description The ACR-N is the smallest percentage improvement in swollen and tender joints and the median of the remaining 5 core parameters, and is expected to be more sensitive to change than the ACR20, ACR50 or ACR70. It is a number varying between 0 and 100, with higher numbers indicating less severity of symptoms. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).
Time Frame Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 84 82 80 86 83 85 82
Mean (Standard Error)
Unit of Measure: percentage of improvement
Week 1 9.27  (1.519) 10.31  (1.578) 14.69  (2.04) 14.25  (1.822) 9.01  (1.603) 11.36  (1.939) 17.63  (2.206)
Week 2 13.85  (1.949) 16.36  (2.125) 25.2  (1.986) 22.61  (2.517) 15.2  (2.063) 20.01  (2.47) 27.77  (2.606)
Week 4 16.93  (2.332) 21.08  (2.598) 31.32  (3.354) 27.45  (2.573) 23.17  (2.668) 26.37  (2.961) 35.69  (2.861)
Week 8 21.6  (2.644) 30.16  (3.015) 38.24  (3.484) 37.88  (3.097) 31.2  (2.845) 33.4  (3.15) 45.36  (3.246)
Week 12 23.09  (2.911) 34.03  (3.335) 39.87  (3.449) 42.1  (3.277) 34.12  (3.144) 35.86  (3.29) 51.17  (3.379)
Week 24 22.06  (2.846) 37.13  (3.582) 50.86  (3.645) 50.4  (3.291) 38.56  (3.384) 40.5  (3.299) 58.69  (3.204)
6.Secondary Outcome
Title Percentage of Participants With Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) Response at Weeks 1, 2, 4, 8, 12, and 24
Hide Description DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None = Actual DAS28 (CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28 (CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2. LOCF algorithm was used.
Time Frame Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
Week 1: None 73 61 58 42 63 64 40
Week 1: Moderate 21 38 35 55 34 32 49
Week 1: Good 6 1 7 3 3 5 11
Week 2: None 58 49 39 31 51 44 20
Week 2: Moderate 33 45 42 53 43 46 62
Week 2: Good 9 6 19 15 6 11 18
Week 4: None 56 44 29 16 37 35 15
Week 4: Moderate 34 46 40 65 44 42 61
Week 4: Good 10 10 31 19 19 22 24
Week 8: None 44 34 20 15 24 24 8
Week 8: Moderate 43 45 52 49 51 49 46
Week 8: Good 13 21 28 36 24 27 45
Week 12: None 41 33 18 8 28 15 7
Week 12: Moderate 45 44 48 55 44 56 43
Week 12: Good 14 23 34 37 28 28 50
Week 24: None 48 33 12 10 23 14 5
Week 24: Moderate 34 35 38 38 37 49 31
Week 24: Good 19 32 51 51 40 36 64
7.Secondary Outcome
Title Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
Hide Description A participant's disease activity status can be defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and Patient Global Assessment of Disease Activity (cm) are all ≤ 1. Non-responder imputation was used.
Time Frame Weeks 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 0 0 3.5 0 0 0 1.2
Week 4 1.2 1.2 1.2 2.3 0 0 2.4
Week 8 1.2 3.7 3.5 3.5 1.2 1.2 3.6
Week 12 3.5 3.7 3.5 5.8 4.7 4.7 9.5
Week 24 1.2 11 8.2 11.6 5.8 3.5 19
8.Secondary Outcome
Title Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
Hide Description

The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), Physician's Global Assessment of Disease Activity (in cm), and CRP (mg/dL). The SDAI was categorized as follows:

• High disease activity: SDAI > 26 • Moderate disease activity: 11 to 26 • Low disease activity: 3.3 to 11 • Remission: ≤ 3.3. LOCF algorithm was used. The SDAI total score ranges from 0 to approximately 86.
Time Frame Baseline and Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants
43.756  (1.2717) 43.77  (1.3499) 45.42  (1.3909) 45.611  (1.3362) 43.951  (1.3224) 44.794  (1.4043) 44.542  (1.3097)
Change at Week 1 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-8.3  (1.25) -8  (1.14) -12.2  (1.45) -12.8  (1.29) -8.2  (1.17) -10  (1.22) -14.5  (1.31)
Change at Week 2 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-11.4  (1.45) -12.5  (1.46) -18.6  (1.64) -16.4  (1.35) -13.4  (1.29) -15.1  (1.43) -20.3  (1.35)
Change at Week 4 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-13.1  (1.47) -16.3  (1.64) -22.7  (1.78) -22.2  (1.28) -17.8  (1.44) -19.3  (1.74) -24.9  (1.54)
Change at Week 8 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-16.3  (1.64) -20.1  (1.86) -24.6  (1.57) -25.9  (1.57) -22.2  (1.68) -23.2  (1.8) -29.2  (1.58)
Change at Week 12 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-16.3  (1.84) -21  (1.84) -25.2  (1.69) -27.2  (1.55) -22.3  (1.71) -24.5  (1.87) -30.6  (1.57)
Change at Week 24 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-15.8  (2) -22.8  (2.07) -30.1  (1.66) -31  (1.66) -24.9  (1.85) -27.9  (2) -34.4  (1.47)
9.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
Hide Description The CDAI is the SDAI modified to exclude CRP and is the sum of the 4 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), and Physician's Global Assessment of Disease Activity (in cm). The CDAI was be categorized as follows: • High disease activity: > 22 • Moderate disease activity: 10 to 22 • Mild disease activity: 2.8 to 10 • Remission: ≤ 2.8. LOCF algorithm was used. The CDAI total score ranges from 0 to approximately 76.
Time Frame Baseline and Weeks 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants
42.131  (1.236) 40.999  (1.2104) 42.966  (1.3014) 42.901  (1.2844) 41.347  (1.2442) 42.333  (1.3186) 41.856  (1.2462)
Change at Week 1 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-8.5  (1.23) -7.2  (1.09) -11.1  (1.38) -11.1  (1.22) -7.3  (1.14) -9  (1.15) -12.8  (1.27)
Change at Week 2 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-11.6  (1.43) -11.7  (1.39) -17.3  (1.58) -14.6  (1.29) -12.4  (1.26) -14  (1.38) -18.4  (1.31)
Change at Week 4 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-13.3  (1.42) -15.2  (1.54) -21.4  (1.71) -20.4  (1.24) -17.1  (1.35) -18  (1.71) -22.8  (1.51)
Change at Week 8 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-16.4  (1.58) -18.9  (1.78) -23.4  (1.52) -24.2  (1.15) -21.1  (1.67) -21.9  (1.75) -27.1  (1.53)
Change at Week 12 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-16.6  (1.84) -19.7  (1.77) -23.8  (1.66) -25.5  (1.5) -21.3  (1.65) -23.2  (1.81) -28.5  (1.49)
Change at Week 24 Number Analyzed 86 participants 82 participants 85 participants 86 participants 85 participants 85 participants 84 participants
-16  (1.95) -21.3  (1.97) -28.6  (1.63) -29.4  (1.5) -23.8  (1.75) -26.7  (1.9) -32.4  (1.39)
10.Secondary Outcome
Title Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
Hide Description FACIT-Fatigue scale is a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life. LOCF algorithm was used.
Time Frame Baseline and Weeks 4, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Mean (Standard Error)
Unit of Measure: units on a scale
Baseline Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants
26.2  (1.09) 26.2  (1.1) 26.6  (1.06) 25.2  (1.25) 28.1  (1.18) 26.2  (1.04) 25.6  (1.25)
Change at Week 4 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
4.9  (1.06) 4.4  (1.11) 9.1  (1.14) 8.5  (1.23) 4.5  (1.06) 6.6  (0.88) 9.9  (0.97)
Change at Week 12 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
5.6  (1.06) 7.6  (1.26) 9.5  (1.21) 11.4  (1.37) 6.9  (1.12) 8.4  (1.08) 11.3  (1.25)
Change at Week 24 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
6  (1.04) 7.9  (1.21) 11.1  (1.2) 11.6  (1.33) 7.7  (1.17) 9  (1.04) 12.8  (1.36)
11.Secondary Outcome
Title Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
Hide Description The SF-36 is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). LOCF algorithm was used.
Time Frame Baseline and Weeks 4, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description:
Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Overall Number of Participants Analyzed 86 82 85 86 86 85 84
Mean (Standard Error)
Unit of Measure: units on a scale
PCS at Baseline Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants
32.999  (0.7121) 32.691  (0.7474) 31.636  (0.7926) 31.625  (0.6355) 31.364  (0.6858) 31.332  (0.726) 32.249  (0.7844)
PCS Change at Week 4 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
3  (0.65) 4.1  (0.88) 6.1  (0.98) 6.4  (0.87) 5  (0.69) 4.2  (0.8) 7.2  (0.77)
PCS Change at Week 12 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
3.2  (0.74) 6.7  (1) 8.4  (0.93) 8.9  (0.9) 7.5  (0.92) 7.1  (0.96) 10.5  (0.98)
PCS Change at Week 24 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
2.8  (0.75) 7.3  (1.02) 9.9  (1.09) 9.7  (0.99) 7.8  (0.85) 7.9  (0.91) 11.6  (1.1)
MCS at Baseline Number Analyzed 86 participants 82 participants 85 participants 86 participants 86 participants 85 participants 84 participants
42.849  (1.0861) 42.199  (1.2581) 43.953  (1.1118) 41.362  (1.1427) 45.527  (1.288) 44.748  (1.228) 42.059  (1.2898)
MCS at Week 4 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
3  (0.92) 3.4  (0.91) 4.9  (0.85) 5.4  (0.98) 2.4  (0.78) 2.7  (0.84) 5.6  (0.92)
MCS at Week 12 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
4.3  (1.05) 4.4  (1.11) 5.1  (0.96) 8.1  (1.17) 3.5  (0.97) 3.1  (1.02) 6.2  (0.98)
MCS at Week 24 Number Analyzed 86 participants 82 participants 84 participants 86 participants 86 participants 85 participants 83 participants
4.7  (0.96) 4.3  (1.04) 6.7  (0.91) 7.2  (1.12) 3.8  (0.96) 3.5  (1.01) 7.1  (1.21)
Time Frame Baseline through end of study drug treatment (average exposure: 160.7 days) plus 10 days
Adverse Event Reporting Description Nonresponders from Placebo (15 participants), 50 mg QD (19 participants) moved to 100 mg QD group and nonresponders from Placebo (15 participants) and 25 mg BID (17 participants) moved to 50 mg BID group from Week 13 to Week 24.
 
Arm/Group Title Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Hide Arm/Group Description Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
All-Cause Mortality
Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/82 (0.00%)   0/119 (0.00%)   0/86 (0.00%)   0/86 (0.00%)   0/117 (0.00%)   1/84 (1.19%) 
Hide Serious Adverse Events
Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/86 (4.65%)   0/82 (0.00%)   4/119 (3.36%)   2/86 (2.33%)   2/86 (2.33%)   0/117 (0.00%)   3/84 (3.57%) 
Blood and lymphatic system disorders               
Anaemia † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Pancytopenia † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
Cardiac disorders               
Pericardial effusion † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Angina unstable † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Acute myocardial infarction † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Ear and labyrinth disorders               
Vertigo † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
General disorders               
Inflammation † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Infections and infestations               
Appendicitis † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Pneumonia † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
Diabetic gangrene † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Subcutaneous abscess † 1  0/86 (0.00%)  0/82 (0.00%)  1/119 (0.84%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Erysipelas † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Intervertebral discitis † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
Septic shock † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
Injury, poisoning and procedural complications               
Lower limb fracture † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  1/84 (1.19%) 
Metabolism and nutrition disorders               
Dehydration † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Musculoskeletal and connective tissue disorders               
Muscle twitching † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Nervous system disorders               
Ischaemic cerebral infarction † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/117 (0.00%)  0/84 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Abortion spontaneous † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  1/86 (1.16%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
Abortion spontaneous complete † 1  0/86 (0.00%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  1/86 (1.16%)  0/117 (0.00%)  0/84 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Hyperventilation † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  0/117 (0.00%)  0/84 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo GLPG0634 50 mg QD GLPG0634 100 mg QD GLPG0634 200 mg QD GLPG0634 25 mg BID GLPG0634 50 mg BID GLPG0634 100 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/86 (12.79%)   23/82 (28.05%)   13/119 (10.92%)   21/86 (24.42%)   23/86 (26.74%)   22/117 (18.80%)   15/84 (17.86%) 
Gastrointestinal disorders               
Nausea † 1  3/86 (3.49%)  7/82 (8.54%)  0/119 (0.00%)  3/86 (3.49%)  3/86 (3.49%)  3/117 (2.56%)  1/84 (1.19%) 
Vomiting † 1  1/86 (1.16%)  0/82 (0.00%)  0/119 (0.00%)  0/86 (0.00%)  0/86 (0.00%)  6/117 (5.13%)  2/84 (2.38%) 
Infections and infestations               
Gastroenteritis † 1  0/86 (0.00%)  1/82 (1.22%)  1/119 (0.84%)  2/86 (2.33%)  5/86 (5.81%)  2/117 (1.71%)  1/84 (1.19%) 
Nasopharyngitis † 1  4/86 (4.65%)  8/82 (9.76%)  3/119 (2.52%)  3/86 (3.49%)  4/86 (4.65%)  2/117 (1.71%)  4/84 (4.76%) 
Upper respiratory tract infection † 1  1/86 (1.16%)  2/82 (2.44%)  2/119 (1.68%)  4/86 (4.65%)  4/86 (4.65%)  6/117 (5.13%)  2/84 (2.38%) 
Metabolism and nutrition disorders               
Hypercholesterolaemia † 1  0/86 (0.00%)  2/82 (2.44%)  0/119 (0.00%)  5/86 (5.81%)  2/86 (2.33%)  1/117 (0.85%)  4/84 (4.76%) 
Nervous system disorders               
Headache † 1  4/86 (4.65%)  1/82 (1.22%)  1/119 (0.84%)  6/86 (6.98%)  6/86 (6.98%)  3/117 (2.56%)  2/84 (2.38%) 
Vascular disorders               
Hypertension † 1  2/86 (2.33%)  3/82 (3.66%)  6/119 (5.04%)  4/86 (4.65%)  3/86 (3.49%)  4/117 (3.42%)  1/84 (1.19%) 
1
Term from vocabulary, MedDRA 18.0
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Information Desk
Organization: Galapagos N.V.
Phone: +32 (0)15 342 900
EMail: rd@glpg.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Galapagos NV
ClinicalTrials.gov Identifier: NCT01888874    
Other Study ID Numbers: GLPG0634-CL-203 (DARWIN1)
2012-003635-31 ( EudraCT Number )
First Submitted: June 26, 2013
First Posted: June 28, 2013
Results First Submitted: October 26, 2020
Results First Posted: November 17, 2020
Last Update Posted: November 17, 2020