Rheumatoid Arthritis
Conditions
Brief summary
* Participants suffering from active rheumatoid arthritis who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) or matching placebo for 24 weeks. * During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.
Detailed description
* Treatment duration was 24 weeks in total. * However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24. * Participants in the other groups maintained their randomized treatment until Week 24.
Interventions
DRUGGLPG0634
GLPG0634 capsules.
DRUGPlacebo
Placebo capsules.
Sponsors
Galapagos NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* male or female subjects who are ≥18 years of age on the day of signing informed consent, * have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III, * have ≥6 swollen joints (from a 66-joint count) and ≥8 tender joints (from a 68-joint count) at Screening and at Baseline, * Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN), * have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX, * have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.
Exclusion criteria
* current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening, * current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy, * previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | Week 12 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| 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 | Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| Percentage of Participants Achieving an ACR20 Response at Week 24 | Week 24 | 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. |
| Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline and Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline and Weeks 1, 2, 4, 8, 12, and 24 | 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. |
| Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline and Weeks 4, 12, and 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. |
| Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | Baseline and Weeks 4, 12, and 24 | 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. |
| Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Weeks 4, 8, 12, and 24 | 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. |
Countries
Argentina, Australia, Austria, Bulgaria, Chile, Colombia, Germany, Guatemala, Hungary, Latvia, Mexico, Moldova, New Zealand, Poland, Romania, Russia, Spain, Ukraine, United States
Participant flow
Recruitment details
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.
Pre-assignment details
A total of 625 participants were screened of which 287 participants were randomized into the study and only 283 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received GLPG0634 matching placebo capsules, orally, QD during Weeks 1 to 12 and GLPG0634 100 mg QD during Weeks 13 to 24. | 72 |
| 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% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. | 72 |
| GLPG0634 100 mg QD Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. | 70 |
| GLPG0634 200 mg QD Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. | 69 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 (Baseline up to Week 12) | Adverse Event | 2 | 0 | 0 | 1 |
| 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) | Other | 0 | 1 | 1 | 0 |
| Period 1 (Baseline up to Week 12) | Treatment failure | 0 | 0 | 1 | 0 |
| 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
| Characteristic | Total | GLPG0634 200 mg QD | Placebo | GLPG0634 100 mg QD | GLPG0634 50 mg QD |
|---|---|---|---|---|---|
| Age, Continuous | 52.1 years | 51.8 years | 51.5 years | 52.8 years | 52.1 years |
| Corrected swollen joint count based on 66 joints (SJC66) at Baseline | 16.834 joint count | 15.74 joint count | 15.98 joint count | 18.653 joint count | 16.969 joint count |
| Corrected tender joint count based on 68 joints (TJC68) at Baseline | 26.051 joint count | 26.242 joint count | 25.226 joint count | 27.195 joint count | 25.58 joint count |
| C-reactive protein (CRP) at Baseline | 27.21 milligram per liter (mg/L) | 23.16 milligram per liter (mg/L) | 35.26 milligram per liter (mg/L) | 25.55 milligram per liter (mg/L) | 24.67 milligram per liter (mg/L) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 98 Participants | 25 Participants | 25 Participants | 25 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants | 44 Participants | 47 Participants | 45 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 65 Participants | 15 Participants | 17 Participants | 16 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 213 Participants | 54 Participants | 53 Participants | 53 Participants | 53 Participants |
| Rheumatoid Arthritis (RA) duration | 8.84 years | 8.68 years | 9.46 years | 8.57 years | 8.63 years |
| Sex: Female, Male Female | 231 Participants | 60 Participants | 56 Participants | 53 Participants | 62 Participants |
| Sex: Female, Male Male | 52 Participants | 9 Participants | 16 Participants | 17 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 | 0 / 85 | 0 / 69 |
| other Total, other adverse events | 9 / 72 | 14 / 72 | 21 / 85 | 16 / 69 |
| serious Total, serious adverse events | 1 / 72 | 2 / 72 | 3 / 85 | 3 / 69 |
Outcome results
Primary
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12
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
Population: Intent-to-treat (ITT) population included all participants in the safety population who had post-randomization data for at least one efficacy parameter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 29.2 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 66.7 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 65.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 72.5 percentage of participants |
Comparison: 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.p-value: <0.000195% CI: [22.4, 52.6]Regression, Logistic
Comparison: 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.p-value: <0.000195% CI: [21.3, 51.8]Regression, Logistic
Comparison: 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.p-value: <0.000195% CI: [28.4, 58.2]Regression, Logistic
Secondary
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 30.46 percentage of improvement | Standard Error 2.986 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 25 percentage of improvement | Standard Error 2.852 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 11.66 percentage of improvement | Standard Error 1.641 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 35.03 percentage of improvement | Standard Error 3.178 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 17.11 percentage of improvement | Standard Error 2.362 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 38.35 percentage of improvement | Standard Error 3.533 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 16.06 percentage of improvement | Standard Error 2.261 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 12.84 percentage of improvement | Standard Error 2.291 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 32.66 percentage of improvement | Standard Error 3.154 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 46.32 percentage of improvement | Standard Error 3.295 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 24.06 percentage of improvement | Standard Error 2.898 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 46.78 percentage of improvement | Standard Error 3.648 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 16.8 percentage of improvement | Standard Error 2.346 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 27.01 percentage of improvement | Standard Error 2.776 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 32.21 percentage of improvement | Standard Error 3.172 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 39.24 percentage of improvement | Standard Error 3.375 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 41 percentage of improvement | Standard Error 3.477 |
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -16.701 units on a scale | Standard Error 1.7003 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 41.438 units on a scale | Standard Error 1.4777 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -9.226 units on a scale | Standard Error 1.1545 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -11.803 units on a scale | Standard Error 1.5275 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -19.087 units on a scale | Standard Error 1.8583 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -21.019 units on a scale | Standard Error 1.7168 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -9.853 units on a scale | Standard Error 1.5591 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -17.654 units on a scale | Standard Error 1.6987 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -21.703 units on a scale | Standard Error 1.7491 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 44.052 units on a scale | Standard Error 1.5383 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -29.502 units on a scale | Standard Error 1.6928 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -24.044 units on a scale | Standard Error 1.9665 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -12.306 units on a scale | Standard Error 1.5618 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -25.071 units on a scale | Standard Error 1.742 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -13.148 units on a scale | Standard Error 1.4085 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -20.044 units on a scale | Standard Error 1.6396 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 41.869 units on a scale | Standard Error 1.423 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -28.102 units on a scale | Standard Error 1.818 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -16.999 units on a scale | Standard Error 1.702 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -24.228 units on a scale | Standard Error 1.6479 |
Secondary
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | 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 1.28 |
| GLPG0634 50 mg QD | 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 | 7.2 units on a scale | Standard Error 1.3 |
| GLPG0634 50 mg QD | 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 | 9.5 units on a scale | Standard Error 1.43 |
| GLPG0634 100 mg QD | 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 | 11.3 units on a scale | Standard Error 1.2 |
| GLPG0634 100 mg QD | 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 | 7.2 units on a scale | Standard Error 1.26 |
| GLPG0634 100 mg QD | Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 24.8 units on a scale | Standard Error 1.13 |
| GLPG0634 100 mg QD | 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 | 10.2 units on a scale | Standard Error 1.21 |
| GLPG0634 200 mg QD | Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 24.8 units on a scale | Standard Error 1.16 |
| GLPG0634 200 mg QD | 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 | 8.5 units on a scale | Standard Error 1.3 |
| GLPG0634 200 mg QD | 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 | 11.2 units on a scale | Standard Error 1.44 |
| GLPG0634 200 mg QD | 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 | 13.7 units on a scale | Standard Error 1.38 |
Secondary
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | 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 | 3.6 units on a scale | Standard Error 1.09 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 42.793 units on a scale | Standard Error 1.3247 |
| GLPG0634 50 mg QD | 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 | 7.1 units on a scale | Standard Error 1.11 |
| GLPG0634 50 mg QD | 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 | 5.7 units on a scale | Standard Error 1.04 |
| GLPG0634 50 mg QD | 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 | 4.9 units on a scale | Standard Error 1.18 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 31.05 units on a scale | Standard Error 0.816 |
| GLPG0634 100 mg QD | 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 | 5.1 units on a scale | Standard Error 0.92 |
| GLPG0634 100 mg QD | 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 | 7.8 units on a scale | Standard Error 1.04 |
| GLPG0634 100 mg QD | 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 | 10 units on a scale | Standard Error 1.17 |
| GLPG0634 100 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 41.185 units on a scale | Standard Error 1.2347 |
| GLPG0634 100 mg QD | 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 | 7.7 units on a scale | Standard Error 1.16 |
| GLPG0634 100 mg QD | 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 | 5.3 units on a scale | Standard Error 1.04 |
| GLPG0634 100 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 30.946 units on a scale | Standard Error 0.7631 |
| GLPG0634 100 mg QD | 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 | 6.9 units on a scale | Standard Error 1.04 |
| GLPG0634 200 mg QD | 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 | 3.9 units on a scale | Standard Error 1.16 |
| GLPG0634 200 mg QD | 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 | 8.5 units on a scale | Standard Error 1.12 |
| GLPG0634 200 mg QD | 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 | 8.6 units on a scale | Standard Error 1.09 |
| GLPG0634 200 mg QD | 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 | 6.8 units on a scale | Standard Error 1.33 |
| GLPG0634 200 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 42.613 units on a scale | Standard Error 1.1674 |
| GLPG0634 200 mg QD | 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 | 6.8 units on a scale | Standard Error 0.92 |
| GLPG0634 200 mg QD | 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 | 9.7 units on a scale | Standard Error 1.09 |
| GLPG0634 200 mg QD | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 31.804 units on a scale | Standard Error 0.8965 |
Secondary
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -17.57 units on a scale | Standard Error 1.7653 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 43.77 units on a scale | Standard Error 1.5609 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | 9.596 units on a scale | Standard Error 1.2567 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -12.194 units on a scale | Standard Error 1.5982 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -20.144 units on a scale | Standard Error 1.9425 |
| GLPG0634 50 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -21.413 units on a scale | Standard Error 1.7953 |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -10.886 units on a scale | Standard Error 1.6511 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -18.862 units on a scale | Standard Error 1.8073 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -23.119 units on a scale | Standard Error 1.8041 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 46.608 units on a scale | Standard Error 1.6538 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -30.983 units on a scale | Standard Error 1.7732 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -25.269 units on a scale | Standard Error 1.9856 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -13.172 units on a scale | Standard Error 1.6209 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -26.499 units on a scale | Standard Error 1.7534 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -14.349 units on a scale | Standard Error 1.4346 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -21.288 units on a scale | Standard Error 1.6619 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 44.139 units on a scale | Standard Error 1.5079 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -29.564 units on a scale | Standard Error 1.8583 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -18.27 units on a scale | Standard Error 1.6934 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -25.556 units on a scale | Standard Error 1.6949 |
Secondary
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 0 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 1.4 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 8.3 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 1.4 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 0 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 8.6 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 0 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 0 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 4.3 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 8.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 4.3 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 1.4 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 7.2 percentage of participants |
Secondary
Percentage of Participants Achieving an ACR20 Response at Week 24
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
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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR20 Response at Week 24 | 56.9 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR20 Response at Week 24 | 78.6 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR20 Response at Week 24 | 66.7 percentage of participants |
Secondary
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 11.1 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 4.2 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 5.6 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 4.2 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 16.7 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 15.3 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.4 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 5.6 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 34.7 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 33.3 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 38.6 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 7.1 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 10 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 25.7 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 37.1 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 18.6 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 44.9 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 7.2 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 21.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 23.2 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 43.5 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 31.9 percentage of participants |
Secondary
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 2.8 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 1.4 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 2.8 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 2.8 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 6.9 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 8.3 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 0 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 8.3 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 1.4 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 19.4 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 18.6 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 1.4 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.4 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 11.4 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 25.7 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 5.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 24.6 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.4 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 4.3 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 11.6 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 17.4 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 13 percentage of participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | 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 |
| GLPG0634 50 mg QD | 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 | 15 percentage of participants |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | 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 | 46 percentage of participants |
| GLPG0634 50 mg QD | 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 | 25 percentage of participants |
| GLPG0634 50 mg QD | 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 | 47 percentage of participants |
| GLPG0634 50 mg QD | 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 | 7 percentage of participants |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | 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 | 36 percentage of participants |
| GLPG0634 50 mg QD | 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 | 57 percentage of participants |
| GLPG0634 50 mg QD | 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 |
| GLPG0634 50 mg QD | 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 | 49 percentage of participants |
| GLPG0634 50 mg QD | 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 | 24 percentage of participants |
| GLPG0634 50 mg QD | 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 | 31 percentage of participants |
| GLPG0634 50 mg QD | 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 | 3 percentage of participants |
| GLPG0634 50 mg QD | 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 | 44 percentage of participants |
| GLPG0634 50 mg QD | 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 | 40 percentage of participants |
| GLPG0634 50 mg QD | 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 | 38 percentage of participants |
| GLPG0634 50 mg QD | 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 | 39 percentage of participants |
| GLPG0634 100 mg QD | 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 | 9 percentage of participants |
| GLPG0634 100 mg QD | 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 | 46 percentage of participants |
| GLPG0634 100 mg QD | 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 | 50 percentage of participants |
| GLPG0634 100 mg QD | 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 | 16 percentage of participants |
| GLPG0634 100 mg QD | 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 | 24 percentage of participants |
| GLPG0634 100 mg QD | 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 | 54 percentage of participants |
| GLPG0634 100 mg QD | 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 | 21 percentage of participants |
| GLPG0634 100 mg QD | 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 | 20 percentage of participants |
| GLPG0634 100 mg QD | 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 | 53 percentage of participants |
| GLPG0634 100 mg QD | 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 | 27 percentage of participants |
| GLPG0634 100 mg QD | 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 | 41 percentage of participants |
| GLPG0634 100 mg QD | 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 | 6 percentage of participants |
| GLPG0634 100 mg QD | 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 | 47 percentage of participants |
| GLPG0634 100 mg QD | 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 | 46 percentage of participants |
| GLPG0634 100 mg QD | 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 | 7 percentage of participants |
| GLPG0634 100 mg QD | 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 | 39 percentage of participants |
| GLPG0634 100 mg QD | 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 | 63 percentage of participants |
| GLPG0634 100 mg QD | 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 | 31 percentage of participants |
| GLPG0634 200 mg QD | 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 | 43 percentage of participants |
| GLPG0634 200 mg QD | 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 | 10 percentage of participants |
| GLPG0634 200 mg QD | 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 | 55 percentage of participants |
| GLPG0634 200 mg QD | 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 | 10 percentage of participants |
| GLPG0634 200 mg QD | 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 | 45 percentage of participants |
| GLPG0634 200 mg QD | 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 | 41 percentage of participants |
| GLPG0634 200 mg QD | 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 | 43 percentage of participants |
| GLPG0634 200 mg QD | 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 | 22 percentage of participants |
| GLPG0634 200 mg QD | 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 | 14 percentage of participants |
| GLPG0634 200 mg QD | 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 | 35 percentage of participants |
| GLPG0634 200 mg QD | 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 | 23 percentage of participants |
| GLPG0634 200 mg QD | 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 | 49 percentage of participants |
| GLPG0634 200 mg QD | 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 | 54 percentage of participants |
| GLPG0634 200 mg QD | 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 | 26 percentage of participants |
| GLPG0634 200 mg QD | 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 | 7 percentage of participants |
| GLPG0634 200 mg QD | 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 | 46 percentage of participants |
| GLPG0634 200 mg QD | 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 | 12 percentage of participants |
| GLPG0634 200 mg QD | 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 | 64 percentage of participants |