Trial Outcomes & Findings for Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2) (NCT NCT01894516)

Last Updated: 2020-12-16

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

287 participants

Primary outcome timeframe

Week 12

Results posted on

2020-12-16

Participant Flow

Participants were enrolled at study sites in Latin America, Europe, United States, and New Zealand. The first participant was screened on 08 October 2013. The last study visit occurred on 29 May 2015.

A total of 625 participants were screened of which 287 participants were randomized into the study and only 283 participants were treated.

Participant milestones

Participant milestones
Measure	Placebo Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24.	GLPG0634 50 mg QD Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20 percent \[%\] improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.	GLPG0634 100 mg QD Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Period 1 (Baseline up to Week 12) STARTED	72	72	70	69
Period 1 (Baseline up to Week 12) COMPLETED	65	67	67	66
Period 1 (Baseline up to Week 12) NOT COMPLETED	7	5	3	3
Period 2 (Week 13 to Week 24) STARTED	0	52	147	66
Period 2 (Week 13 to Week 24) COMPLETED	0	50	142	65
Period 2 (Week 13 to Week 24) NOT COMPLETED	0	2	5	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24.	GLPG0634 50 mg QD Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20 percent \[%\] improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.	GLPG0634 100 mg QD Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Period 1 (Baseline up to Week 12) Other	0	1	1	0
Period 1 (Baseline up to Week 12) Adverse event and treatment failure	2	0	0	0
Period 1 (Baseline up to Week 12) Non compliance with the study medication	1	1	0	0
Period 1 (Baseline up to Week 12) Treatment failure	0	0	1	0
Period 1 (Baseline up to Week 12) Adverse Event	2	0	0	1
Period 1 (Baseline up to Week 12) Withdrawal by Subject	2	3	1	2
Period 2 (Week 13 to Week 24) Adverse Event	0	2	3	1
Period 2 (Week 13 to Week 24) Withdrawal by Subject	0	0	2	0

Baseline Characteristics

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.	Total n=283 Participants Total of all reporting groups
Age, Continuous	51.5 years n=93 Participants	52.1 years n=4 Participants	52.8 years n=27 Participants	51.8 years n=483 Participants	52.1 years n=36 Participants
Sex: Female, Male Female	56 Participants n=93 Participants	62 Participants n=4 Participants	53 Participants n=27 Participants	60 Participants n=483 Participants	231 Participants n=36 Participants
Sex: Female, Male Male	16 Participants n=93 Participants	10 Participants n=4 Participants	17 Participants n=27 Participants	9 Participants n=483 Participants	52 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=93 Participants	23 Participants n=4 Participants	25 Participants n=27 Participants	25 Participants n=483 Participants	98 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=93 Participants	49 Participants n=4 Participants	45 Participants n=27 Participants	44 Participants n=483 Participants	185 Participants n=36 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants
Race (NIH/OMB) White	53 Participants n=93 Participants	53 Participants n=4 Participants	53 Participants n=27 Participants	54 Participants n=483 Participants	213 Participants n=36 Participants
Race (NIH/OMB) More than one race	17 Participants n=93 Participants	17 Participants n=4 Participants	16 Participants n=27 Participants	15 Participants n=483 Participants	65 Participants n=36 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Rheumatoid Arthritis (RA) duration	9.46 years n=93 Participants	8.63 years n=4 Participants	8.57 years n=27 Participants	8.68 years n=483 Participants	8.84 years n=36 Participants
C-reactive protein (CRP) at Baseline	35.26 milligram per liter (mg/L) n=93 Participants	24.67 milligram per liter (mg/L) n=4 Participants	25.55 milligram per liter (mg/L) n=27 Participants	23.16 milligram per liter (mg/L) n=483 Participants	27.21 milligram per liter (mg/L) n=36 Participants
Corrected tender joint count based on 68 joints (TJC68) at Baseline	25.226 joint count n=93 Participants	25.58 joint count n=4 Participants	27.195 joint count n=27 Participants	26.242 joint count n=483 Participants	26.051 joint count n=36 Participants
Corrected swollen joint count based on 66 joints (SJC66) at Baseline	15.98 joint count n=93 Participants	16.969 joint count n=4 Participants	18.653 joint count n=27 Participants	15.74 joint count n=483 Participants	16.834 joint count n=36 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Intent-to-treat (ITT) population included all participants in the safety population who had post-randomization data for at least one efficacy parameter.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12	29.2 percentage of participants	66.7 percentage of participants	65.7 percentage of participants	72.5 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: All patients from the ITT population who were randomized to a GLPG0634 arm. The data for participants switching from placebo to GLPG0634 100 mg at Week 12 were not in scope for this analysis and were not reported.

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.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=70 Participants 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.	GLPG0634 100 mg QD n=69 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Percentage of Participants Achieving an ACR20 Response at Week 24	56.9 percentage of participants	78.6 percentage of participants	66.7 percentage of participants	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 1	1.4 percentage of participants	1.4 percentage of participants	10 percentage of participants	7.2 percentage of participants
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 2	4.2 percentage of participants	5.6 percentage of participants	7.1 percentage of participants	21.7 percentage of participants
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 4	4.2 percentage of participants	15.3 percentage of participants	18.6 percentage of participants	23.2 percentage of participants
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 8	5.6 percentage of participants	16.7 percentage of participants	25.7 percentage of participants	31.9 percentage of participants
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 12	11.1 percentage of participants	34.7 percentage of participants	37.1 percentage of participants	43.5 percentage of participants
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 24	—	33.3 percentage of participants	38.6 percentage of participants	44.9 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 1	0 percentage of participants	0 percentage of participants	1.4 percentage of participants	1.4 percentage of participants
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 2	2.8 percentage of participants	1.4 percentage of participants	1.4 percentage of participants	4.3 percentage of participants
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 4	1.4 percentage of participants	8.3 percentage of participants	5.7 percentage of participants	11.6 percentage of participants
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 8	2.8 percentage of participants	6.9 percentage of participants	11.4 percentage of participants	17.4 percentage of participants
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 12	2.8 percentage of participants	8.3 percentage of participants	18.6 percentage of participants	13 percentage of participants
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 Week 24	—	19.4 percentage of participants	25.7 percentage of participants	24.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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). All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 1	6.79 percentage of improvement Standard Error 1.34	11.66 percentage of improvement Standard Error 1.641	12.84 percentage of improvement Standard Error 2.291	16.8 percentage of improvement Standard Error 2.346
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 2	10.79 percentage of improvement Standard Error 1.917	17.11 percentage of improvement Standard Error 2.362	16.06 percentage of improvement Standard Error 2.261	27.01 percentage of improvement Standard Error 2.776
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 4	12.03 percentage of improvement Standard Error 2.058	25 percentage of improvement Standard Error 2.852	24.06 percentage of improvement Standard Error 2.898	32.21 percentage of improvement Standard Error 3.172
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 8	13.35 percentage of improvement Standard Error 2.24	30.46 percentage of improvement Standard Error 2.986	32.66 percentage of improvement Standard Error 3.154	39.24 percentage of improvement Standard Error 3.375
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 12	16.28 percentage of improvement Standard Error 2.723	35.03 percentage of improvement Standard Error 3.178	38.35 percentage of improvement Standard Error 3.533	41 percentage of improvement Standard Error 3.477
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 Week 24	—	38.75 percentage of improvement Standard Error 3.748	46.32 percentage of improvement Standard Error 3.295	46.78 percentage of improvement Standard Error 3.648

SECONDARY outcome

Timeframe: Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
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 Week 4: Good	7 percentage of participants	15 percentage of participants	16 percentage of participants	23 percentage of participants
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 Week 1: None	72 percentage of participants	57 percentage of participants	63 percentage of participants	49 percentage of participants
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 Week 1: Moderate	26 percentage of participants	40 percentage of participants	31 percentage of participants	43 percentage of participants
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 Week 1: Good	1 percentage of participants	3 percentage of participants	6 percentage of participants	7 percentage of participants
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 Week 2: None	67 percentage of participants	44 percentage of participants	47 percentage of participants	26 percentage of participants
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 Week 2: Moderate	31 percentage of participants	49 percentage of participants	46 percentage of participants	64 percentage of participants
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 Week 2: Good	3 percentage of participants	7 percentage of participants	7 percentage of participants	10 percentage of participants
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 Week 4: None	58 percentage of participants	38 percentage of participants	39 percentage of participants	22 percentage of participants
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 Week 4: Moderate	35 percentage of participants	47 percentage of participants	46 percentage of participants	55 percentage of participants
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 Week 8: None	54 percentage of participants	36 percentage of participants	24 percentage of participants	12 percentage of participants
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 Week 8: Moderate	36 percentage of participants	39 percentage of participants	54 percentage of participants	54 percentage of participants
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 Week 8: Good	10 percentage of participants	25 percentage of participants	21 percentage of participants	35 percentage of participants
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 Week 12: None	49 percentage of participants	31 percentage of participants	20 percentage of participants	14 percentage of participants
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 Week 12: Moderate	38 percentage of participants	46 percentage of participants	53 percentage of participants	41 percentage of participants
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 Week 12: Good	14 percentage of participants	24 percentage of participants	27 percentage of participants	45 percentage of participants
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 Week 24: None	—	28 percentage of participants	9 percentage of participants	10 percentage of participants
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 Week 24: Moderate	—	36 percentage of participants	41 percentage of participants	43 percentage of participants
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 Week 24: Good	—	36 percentage of participants	50 percentage of participants	46 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=72 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 Week 4	0 percentage of participants	1.4 percentage of participants	0 percentage of participants	1.4 percentage of participants
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 Week 8	0 percentage of participants	0 percentage of participants	0 percentage of participants	7.2 percentage of participants
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 Week 12	1.4 percentage of participants	1.4 percentage of participants	4.3 percentage of participants	4.3 percentage of participants
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 Week 24	—	8.3 percentage of participants	8.6 percentage of participants	8.7 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=70 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=68 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Baseline	45.73 units on a scale Standard Error 1.4789	43.77 units on a scale Standard Error 1.5609	46.608 units on a scale Standard Error 1.6538	44.139 units on a scale Standard Error 1.5079
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 1	-7.45 units on a scale Standard Error 1.5528	9.596 units on a scale Standard Error 1.2567	-10.886 units on a scale Standard Error 1.6511	-14.349 units on a scale Standard Error 1.4346
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 2	-10.022 units on a scale Standard Error 1.371	-12.194 units on a scale Standard Error 1.5982	-13.172 units on a scale Standard Error 1.6209	-18.27 units on a scale Standard Error 1.6934
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 4	-10.927 units on a scale Standard Error 1.7771	-17.57 units on a scale Standard Error 1.7653	-18.862 units on a scale Standard Error 1.8073	-21.288 units on a scale Standard Error 1.6619
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 8	-12.452 units on a scale Standard Error 1.7748	-20.144 units on a scale Standard Error 1.9425	-23.119 units on a scale Standard Error 1.8041	-25.556 units on a scale Standard Error 1.6949
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 12	-12.574 units on a scale Standard Error 1.984	-21.413 units on a scale Standard Error 1.7953	-25.269 units on a scale Standard Error 1.9856	-26.499 units on a scale Standard Error 1.7534
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 24	—	-23.16 units on a scale Standard Error 1.9364	-30.983 units on a scale Standard Error 1.7732	-29.564 units on a scale Standard Error 1.8583

SECONDARY outcome

Timeframe: Baseline and Weeks 1, 2, 4, 8, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=70 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=68 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Baseline	42.168 units on a scale Standard Error 1.3272	41.438 units on a scale Standard Error 1.4777	44.052 units on a scale Standard Error 1.5383	41.869 units on a scale Standard Error 1.423
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 1	-6.867 units on a scale Standard Error 1.4538	-9.226 units on a scale Standard Error 1.1545	-9.853 units on a scale Standard Error 1.5591	-13.148 units on a scale Standard Error 1.4085
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 2	-9.861 units on a scale Standard Error 1.1909	-11.803 units on a scale Standard Error 1.5275	-12.306 units on a scale Standard Error 1.5618	-16.999 units on a scale Standard Error 1.702
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 4	-10.743 units on a scale Standard Error 1.7184	-16.701 units on a scale Standard Error 1.7003	-17.654 units on a scale Standard Error 1.6987	-20.044 units on a scale Standard Error 1.6396
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 8	-12.071 units on a scale Standard Error 1.6982	-19.087 units on a scale Standard Error 1.8583	-21.703 units on a scale Standard Error 1.7491	-24.228 units on a scale Standard Error 1.6479
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 12	11.696 units on a scale Standard Error 1.8752	-21.019 units on a scale Standard Error 1.7168	-24.044 units on a scale Standard Error 1.9665	-25.071 units on a scale Standard Error 1.742
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 Change at Week 24	—	-22.278 units on a scale Standard Error 1.8637	-29.502 units on a scale Standard Error 1.6928	-28.102 units on a scale Standard Error 1.818

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=70 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 Baseline	25.1 units on a scale Standard Error 1.12	25.1 units on a scale Standard Error 1.28	24.8 units on a scale Standard Error 1.13	24.8 units on a scale Standard Error 1.16
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 Change at Week 4	1.4 units on a scale Standard Error 1.14	7.2 units on a scale Standard Error 1.3	7.2 units on a scale Standard Error 1.26	8.5 units on a scale Standard Error 1.3
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 Change at Week 12	3.9 units on a scale Standard Error 1.23	9.5 units on a scale Standard Error 1.43	10.2 units on a scale Standard Error 1.21	11.2 units on a scale Standard Error 1.44
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 Change at Week 24	—	10 units on a scale Standard Error 1.43	11.3 units on a scale Standard Error 1.2	13.7 units on a scale Standard Error 1.38

SECONDARY outcome

Timeframe: Baseline and Weeks 4, 12, and 24

Population: ITT population with available data were analyzed. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Outcome measures

Outcome measures
Measure	Placebo n=71 Participants Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg, QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=70 Participants 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.	GLPG0634 100 mg QD n=70 Participants Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 Participants Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 PCS at Baseline	31.1 units on a scale Standard Error 0.6988	31.05 units on a scale Standard Error 0.816	30.946 units on a scale Standard Error 0.7631	31.804 units on a scale Standard Error 0.8965
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 PCS Change at Week 4	2.1 units on a scale Standard Error 0.72	5.7 units on a scale Standard Error 1.04	5.1 units on a scale Standard Error 0.92	6.8 units on a scale Standard Error 0.92
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 PCS Change at Week 12	3 units on a scale Standard Error 0.89	7.1 units on a scale Standard Error 1.11	7.8 units on a scale Standard Error 1.04	8.6 units on a scale Standard Error 1.09
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 PCS Change at Week 24	—	6.9 units on a scale Standard Error 1.16	10 units on a scale Standard Error 1.17	9.7 units on a scale Standard Error 1.09
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 MCS at Baseline	40.525 units on a scale Standard Error 1.3053	42.793 units on a scale Standard Error 1.3247	41.185 units on a scale Standard Error 1.2347	42.613 units on a scale Standard Error 1.1674
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 MCS at Week 4	2.1 units on a scale Standard Error 1.1	3.6 units on a scale Standard Error 1.09	5.3 units on a scale Standard Error 1.04	3.9 units on a scale Standard Error 1.16
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 MCS at Week 12	2.7 units on a scale Standard Error 1.04	4.9 units on a scale Standard Error 1.18	6.9 units on a scale Standard Error 1.04	6.8 units on a scale Standard Error 1.33
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 MCS at Week 24	—	5.1 units on a scale Standard Error 1.27	7.7 units on a scale Standard Error 1.16	8.5 units on a scale Standard Error 1.12

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

GLPG0634 50 mg QD

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

GLPG0634 100 mg QD

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

GLPG0634 200 mg QD

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=72 participants at risk Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 participants at risk 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.	GLPG0634 100 mg QD n=85 participants at risk Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 participants at risk Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Ear and labyrinth disorders Vertigo	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.2% 1/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Cellulitis	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.2% 1/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Gastroenteritis	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Pneumonia	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Pyelonephritis chronic	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.2% 1/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.

Other adverse events

Other adverse events
Measure	Placebo n=72 participants at risk Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24.	GLPG0634 50 mg QD n=72 participants at risk 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.	GLPG0634 100 mg QD n=85 participants at risk Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	GLPG0634 200 mg QD n=69 participants at risk Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Vascular disorders Hypertension	5.6% 4/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	4.2% 3/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.2% 1/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	2.9% 2/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Blood and lymphatic system disorders Anaemia	0.00% 0/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	0.00% 0/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.8% 4/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Nervous system disorders Headache	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.6% 4/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.2% 1/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	4.3% 3/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Metabolism and nutrition disorders Hypercholesterolaemia	4.2% 3/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.6% 4/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.9% 5/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	2.8% 2/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.9% 5/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	1.4% 1/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Upper respiratory tract infection	2.8% 2/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	2.8% 2/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	4.7% 4/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.8% 4/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.
Infections and infestations Urinary tract infection	1.4% 1/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	4.2% 3/72 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	8.2% 7/85 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.	5.8% 4/69 • Baseline through end of study drug treatment (average exposure: 161.0 days) Nonresponders from 50 mg QD (15 participants) moved to 100 mg QD group for Week 13 to 24.

Additional Information

Clinical Trial Information Desk

Galapagos N.V.

Phone: +32 (0)15 342 900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER