Rheumatoid Arthritis
Conditions
Keywords
Methotrexate inadequate responders
Brief summary
Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram \[mg\], 100 mg and 200 mg daily -, each evaluated as once daily \[QD\] and twice daily \[BID\] regimen) 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 and dose regiments 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, participants on placebo who did not achieve a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) were re-randomized (automatically via interactive voice/web response \[IXRS\]) to treatment to receive GLPG0634 100 mg QD or 50 mg BID doses in a blinded fashion, participants on 50 mg QD who had not achieved a 20% improvement in SJC66 and TJC68 were assigned to 100 mg QD and participants on 25 mg BID. who did not achieve a 20% improvement in SJC66 and TJC68 were assigned to 50 mg BID. All continued the study 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
* 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 received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.
Exclusion criteria
* current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX, * current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | 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. |
Countries
Argentina, Australia, Austria, Belgium, Bulgaria, Chile, Colombia, Czechia, France, Germany, Guatemala, Hungary, Israel, Latvia, Mexico, Moldova, New Zealand, Poland, Russia, Spain, Ukraine, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Europe, South America, North America, Australia, and New Zealand. The first participant was screened on 17 July 2013. The last study visit occurred on 14 May 2015.
Pre-assignment details
A total of 1255 participants were screened of which 599 participants were randomized into the study and only 594 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants received GLPG0634 matching placebo capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20 percent% improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 mg QD or 50 mg BID during Weeks 13 to 24. | 86 |
| 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. | 82 |
| GLPG0634 100 mg QD Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. | 85 |
| GLPG0634 200 mg QD Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. | 86 |
| GLPG0634 25 mg BID Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24. | 86 |
| GLPG0634 50 mg BID Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. | 85 |
| GLPG0634 100 mg BID Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24. | 84 |
| Total | 594 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Period 1 (Baseline up to Week 12) | Adverse Event | 0 | 2 | 3 | 1 | 2 | 1 | 0 |
| Period 1 (Baseline up to Week 12) | Adverse event and treatment failure | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 1 (Baseline up to Week 12) | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Period 1 (Baseline up to Week 12) | Non-compliance with the study procedures | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Period 1 (Baseline up to Week 12) | Other | 1 | 0 | 1 | 1 | 3 | 3 | 0 |
| Period 1 (Baseline up to Week 12) | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Period 1 (Baseline up to Week 12) | Withdrawal by Subject | 2 | 2 | 3 | 4 | 3 | 0 | 0 |
| Period 2 (Week 13 to Week 24) | Adverse Event | 2 | 0 | 3 | 2 | 1 | 1 | 3 |
| Period 2 (Week 13 to Week 24) | Adverse event and treatment failure | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Period 2 (Week 13 to Week 24) | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Period 2 (Week 13 to Week 24) | Non compliance with study medication | 0 | 0 | 2 | 0 | 0 | 1 | 0 |
| Period 2 (Week 13 to Week 24) | Treatment failure | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Period 2 (Week 13 to Week 24) | Withdrawal by Subject | 1 | 1 | 2 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | GLPG0634 100 mg BID | GLPG0634 50 mg BID | GLPG0634 25 mg BID | GLPG0634 50 mg QD | GLPG0634 200 mg QD | Placebo | GLPG0634 100 mg QD |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 53.4 years | 53.9 years | 55.4 years | 52.4 years | 52.8 years | 54.8 years | 52 years | 52.3 years |
| Corrected swollen joint count based on 66 joints (SJC66) at Baseline | 16.622 joint count | 16.356 joint count | 17.534 joint count | 15.663 joint count | 17.023 joint count | 17.355 joint count | 16.13 joint count | 16.31 joint count |
| Corrected tender joint count based on 68 joints (TJC68) at Baseline | 26.091 joint count | 25.946 joint count | 27.158 joint count | 25.427 joint count | 24.907 joint count | 28.843 joint count | 24.984 joint count | 25.319 joint count |
| C-reactive protein (CRP) at Baseline | 24.70 milligram per liter (mg/L) | 26.86 milligram per liter (mg/L) | 24.6 milligram per liter (mg/L) | 26.01 milligram per liter (mg/L) | 27.71 milligram per liter (mg/L) | 27.1 milligram per liter (mg/L) | 16.25 milligram per liter (mg/L) | 24.54 milligram per liter (mg/L) |
| Ethnicity (NIH/OMB) Hispanic or Latino | 245 Participants | 38 Participants | 30 Participants | 37 Participants | 37 Participants | 33 Participants | 37 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 349 Participants | 46 Participants | 55 Participants | 49 Participants | 45 Participants | 53 Participants | 49 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 146 Participants | 17 Participants | 19 Participants | 23 Participants | 21 Participants | 18 Participants | 26 Participants | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 443 Participants | 66 Participants | 65 Participants | 63 Participants | 61 Participants | 67 Participants | 59 Participants | 62 Participants |
| Rheumatoid Arthritis (RA) duration | 8.29 years | 9.74 years | 7.79 years | 8.88 years | 7.21 years | 8.51 years | 8.21 years | 7.67 years |
| Sex: Female, Male Female | 481 Participants | 70 Participants | 65 Participants | 68 Participants | 69 Participants | 74 Participants | 70 Participants | 65 Participants |
| Sex: Female, Male Male | 113 Participants | 14 Participants | 20 Participants | 18 Participants | 13 Participants | 12 Participants | 16 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 82 | 0 / 119 | 0 / 86 | 0 / 86 | 0 / 117 | 1 / 84 |
| other Total, other adverse events | 11 / 86 | 23 / 82 | 13 / 119 | 21 / 86 | 23 / 86 | 22 / 117 | 15 / 84 |
| serious Total, serious adverse events | 4 / 86 | 0 / 82 | 4 / 119 | 2 / 86 | 2 / 86 | 0 / 117 | 3 / 84 |
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 | 44.2 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 56.1 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 63.5 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 68.6 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 57 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 60 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12 | 78.6 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: 0.123695% CI: [-3.1, 26.9]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: 0.043595% CI: [4.7, 34]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: 0.006895% CI: [10.1, 38.8]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: 0.123695% CI: [-2, 27.6]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: 0.105695% CI: [1, 30.6]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: [20.7, 48.1]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).
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 8 | 21.6 percentage of improvement | Standard Error 2.644 |
| Placebo | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 23.09 percentage of improvement | Standard Error 2.911 |
| Placebo | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 16.93 percentage of improvement | Standard Error 2.332 |
| Placebo | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 22.06 percentage of improvement | Standard Error 2.846 |
| Placebo | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 13.85 percentage of improvement | Standard Error 1.949 |
| Placebo | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 9.27 percentage of improvement | Standard Error 1.519 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 10.31 percentage of improvement | Standard Error 1.578 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 34.03 percentage of improvement | Standard Error 3.335 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 16.36 percentage of improvement | Standard Error 2.125 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 21.08 percentage of improvement | Standard Error 2.598 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 37.13 percentage of improvement | Standard Error 3.582 |
| GLPG0634 50 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 30.16 percentage of improvement | Standard Error 3.015 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 14.69 percentage of improvement | Standard Error 2.04 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 38.24 percentage of improvement | Standard Error 3.484 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 50.86 percentage of improvement | Standard Error 3.645 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 25.2 percentage of improvement | Standard Error 1.986 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 39.87 percentage of improvement | Standard Error 3.449 |
| GLPG0634 100 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 31.32 percentage of improvement | Standard Error 3.354 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 22.61 percentage of improvement | Standard Error 2.517 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 14.25 percentage of improvement | Standard Error 1.822 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 27.45 percentage of improvement | Standard Error 2.573 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 37.88 percentage of improvement | Standard Error 3.097 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 42.1 percentage of improvement | Standard Error 3.277 |
| GLPG0634 200 mg QD | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 50.4 percentage of improvement | Standard Error 3.291 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 38.56 percentage of improvement | Standard Error 3.384 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 31.2 percentage of improvement | Standard Error 2.845 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 15.2 percentage of improvement | Standard Error 2.063 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 34.12 percentage of improvement | Standard Error 3.144 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 9.01 percentage of improvement | Standard Error 1.603 |
| GLPG0634 25 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 23.17 percentage of improvement | Standard Error 2.668 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 20.01 percentage of improvement | Standard Error 2.47 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 40.5 percentage of improvement | Standard Error 3.299 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 35.86 percentage of improvement | Standard Error 3.29 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 11.36 percentage of improvement | Standard Error 1.939 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 26.37 percentage of improvement | Standard Error 2.961 |
| GLPG0634 50 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 33.4 percentage of improvement | Standard Error 3.15 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 45.36 percentage of improvement | Standard Error 3.246 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 27.77 percentage of improvement | Standard Error 2.606 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 35.69 percentage of improvement | Standard Error 2.861 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 58.69 percentage of improvement | Standard Error 3.204 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 51.17 percentage of improvement | Standard Error 3.379 |
| GLPG0634 100 mg BID | ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 17.63 percentage of improvement | Standard Error 2.206 |
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.
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 | Change at Week 4 | -13.3 units on a scale | Standard Error 1.42 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 42.131 units on a scale | Standard Error 1.236 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -16 units on a scale | Standard Error 1.95 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -8.5 units on a scale | Standard Error 1.23 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -16.6 units on a scale | Standard Error 1.84 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -11.6 units on a scale | Standard Error 1.43 |
| Placebo | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -16.4 units on a scale | Standard Error 1.58 |
| GLPG0634 50 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 40.999 units on a scale | Standard Error 1.2104 |
| 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 | -7.2 units on a scale | Standard Error 1.09 |
| 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 | -19.7 units on a scale | Standard Error 1.77 |
| 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 | -18.9 units on a scale | Standard Error 1.78 |
| 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 | -15.2 units on a scale | Standard Error 1.54 |
| 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 | -11.7 units on a scale | Standard Error 1.39 |
| 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 | -21.3 units on a scale | Standard Error 1.97 |
| 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 | -17.3 units on a scale | Standard Error 1.58 |
| 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 | -28.6 units on a scale | Standard Error 1.63 |
| 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 | -11.1 units on a scale | Standard Error 1.38 |
| GLPG0634 100 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 42.966 units on a scale | Standard Error 1.3014 |
| 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 | -23.8 units on a scale | Standard Error 1.66 |
| 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 | -21.4 units on a scale | Standard Error 1.71 |
| 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 | -23.4 units on a scale | Standard Error 1.52 |
| 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 | -20.4 units on a scale | Standard Error 1.24 |
| GLPG0634 200 mg QD | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 42.901 units on a scale | Standard Error 1.2844 |
| 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 | -11.1 units on a scale | Standard Error 1.22 |
| 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 | -14.6 units on a scale | Standard Error 1.29 |
| 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 | -24.2 units on a scale | Standard Error 1.15 |
| 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 | -25.5 units on a scale | Standard Error 1.5 |
| 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 | -29.4 units on a scale | Standard Error 1.5 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -23.8 units on a scale | Standard Error 1.75 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 41.347 units on a scale | Standard Error 1.2442 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -17.1 units on a scale | Standard Error 1.35 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -12.4 units on a scale | Standard Error 1.26 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -7.3 units on a scale | Standard Error 1.14 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -21.3 units on a scale | Standard Error 1.65 |
| GLPG0634 25 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -21.1 units on a scale | Standard Error 1.67 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -26.7 units on a scale | Standard Error 1.9 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 42.333 units on a scale | Standard Error 1.3186 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -9 units on a scale | Standard Error 1.15 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -21.9 units on a scale | Standard Error 1.75 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -23.2 units on a scale | Standard Error 1.81 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -18 units on a scale | Standard Error 1.71 |
| GLPG0634 50 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -14 units on a scale | Standard Error 1.38 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -22.8 units on a scale | Standard Error 1.51 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -27.1 units on a scale | Standard Error 1.53 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -12.8 units on a scale | Standard Error 1.27 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -28.5 units on a scale | Standard Error 1.49 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 41.856 units on a scale | Standard Error 1.2462 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -32.4 units on a scale | Standard Error 1.39 |
| GLPG0634 100 mg BID | Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -18.4 units on a scale | Standard Error 1.31 |
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.
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 Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 26.2 units on a scale | Standard Error 1.09 |
| 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 | 4.9 units on a scale | Standard Error 1.06 |
| 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 | 5.6 units on a scale | Standard Error 1.06 |
| 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 24 | 6 units on a scale | Standard Error 1.04 |
| 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 | 7.9 units on a scale | Standard Error 1.21 |
| 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 | 7.6 units on a scale | Standard Error 1.26 |
| 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 | 26.2 units on a scale | Standard Error 1.1 |
| 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 | 4.4 units on a scale | Standard Error 1.11 |
| 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 | 9.5 units on a scale | Standard Error 1.21 |
| 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 | 9.1 units on a scale | Standard Error 1.14 |
| 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 | 26.6 units on a scale | Standard Error 1.06 |
| 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 | 11.1 units on a scale | Standard Error 1.2 |
| 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 | 25.2 units on a scale | Standard Error 1.25 |
| 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 1.23 |
| 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 | 11.4 units on a scale | Standard Error 1.37 |
| 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 | 11.6 units on a scale | Standard Error 1.33 |
| GLPG0634 25 mg BID | Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 28.1 units on a scale | Standard Error 1.18 |
| GLPG0634 25 mg BID | 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 | 7.7 units on a scale | Standard Error 1.17 |
| GLPG0634 25 mg BID | 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 | 4.5 units on a scale | Standard Error 1.06 |
| GLPG0634 25 mg BID | 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 | 6.9 units on a scale | Standard Error 1.12 |
| GLPG0634 50 mg BID | 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 | 6.6 units on a scale | Standard Error 0.88 |
| GLPG0634 50 mg BID | Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 26.2 units on a scale | Standard Error 1.04 |
| GLPG0634 50 mg BID | 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 | 8.4 units on a scale | Standard Error 1.08 |
| GLPG0634 50 mg BID | 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 | 9 units on a scale | Standard Error 1.04 |
| GLPG0634 100 mg BID | 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 | 11.3 units on a scale | Standard Error 1.25 |
| GLPG0634 100 mg BID | Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24 | Baseline | 25.6 units on a scale | Standard Error 1.25 |
| GLPG0634 100 mg BID | 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 | 9.9 units on a scale | Standard Error 0.97 |
| GLPG0634 100 mg BID | 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 | 12.8 units on a scale | Standard Error 1.36 |
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.
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 Change at Week 12 | 3.2 units on a scale | Standard Error 0.74 |
| 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 | 3 units on a scale | Standard Error 0.65 |
| 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 | 32.999 units on a scale | Standard Error 0.7121 |
| 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 24 | 2.8 units on a scale | Standard Error 0.75 |
| 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 | 42.849 units on a scale | Standard Error 1.0861 |
| 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 | 3 units on a scale | Standard Error 0.92 |
| 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 | 4.3 units on a scale | Standard Error 1.05 |
| 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 24 | 4.7 units on a scale | Standard Error 0.96 |
| 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 | 4.1 units on a scale | Standard Error 0.88 |
| 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 | 4.3 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 | PCS Change at Week 12 | 6.7 units on a scale | Standard Error 1 |
| 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 | 7.3 units on a scale | Standard Error 1.02 |
| 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 | 42.199 units on a scale | Standard Error 1.2581 |
| 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 | 3.4 units on a scale | Standard Error 0.91 |
| 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 | 4.4 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 at Baseline | 32.691 units on a scale | Standard Error 0.7474 |
| 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 | 8.4 units on a scale | Standard Error 0.93 |
| 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 | 6.7 units on a scale | Standard Error 0.91 |
| 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 | 9.9 units on a scale | Standard Error 1.09 |
| 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 | 43.953 units on a scale | Standard Error 1.1118 |
| 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 | 4.9 units on a scale | Standard Error 0.85 |
| 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 | 5.1 units on a scale | Standard Error 0.96 |
| 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 | 6.1 units on a scale | Standard Error 0.98 |
| 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 | 31.636 units on a scale | Standard Error 0.7926 |
| 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 0.99 |
| 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 | 7.2 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 | MCS at Baseline | 41.362 units on a scale | Standard Error 1.1427 |
| 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 | 5.4 units on a scale | Standard Error 0.98 |
| 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 | 8.1 units on a scale | Standard Error 1.17 |
| 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 | 8.9 units on a scale | Standard Error 0.9 |
| 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 | 31.625 units on a scale | Standard Error 0.6355 |
| 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 | 6.4 units on a scale | Standard Error 0.87 |
| GLPG0634 25 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 45.527 units on a scale | Standard Error 1.288 |
| GLPG0634 25 mg BID | 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 | 3.8 units on a scale | Standard Error 0.96 |
| GLPG0634 25 mg BID | 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 | 2.4 units on a scale | Standard Error 0.78 |
| GLPG0634 25 mg BID | 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 | 3.5 units on a scale | Standard Error 0.97 |
| GLPG0634 25 mg BID | 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 | 7.8 units on a scale | Standard Error 0.85 |
| GLPG0634 25 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 31.364 units on a scale | Standard Error 0.6858 |
| GLPG0634 25 mg BID | 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 units on a scale | Standard Error 0.69 |
| GLPG0634 25 mg BID | 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 | 7.5 units on a scale | Standard Error 0.92 |
| GLPG0634 50 mg BID | 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 | 2.7 units on a scale | Standard Error 0.84 |
| GLPG0634 50 mg BID | 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 | 3.5 units on a scale | Standard Error 1.01 |
| GLPG0634 50 mg BID | 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 | 3.1 units on a scale | Standard Error 1.02 |
| GLPG0634 50 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 44.748 units on a scale | Standard Error 1.228 |
| GLPG0634 50 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 31.332 units on a scale | Standard Error 0.726 |
| GLPG0634 50 mg BID | 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 | 4.2 units on a scale | Standard Error 0.8 |
| GLPG0634 50 mg BID | 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 0.96 |
| GLPG0634 50 mg BID | 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 | 7.9 units on a scale | Standard Error 0.91 |
| GLPG0634 100 mg BID | 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 | 6.2 units on a scale | Standard Error 0.98 |
| GLPG0634 100 mg BID | 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 | 5.6 units on a scale | Standard Error 0.92 |
| GLPG0634 100 mg BID | 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 | 7.1 units on a scale | Standard Error 1.21 |
| GLPG0634 100 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | PCS at Baseline | 32.249 units on a scale | Standard Error 0.7844 |
| GLPG0634 100 mg BID | 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 | 7.2 units on a scale | Standard Error 0.77 |
| GLPG0634 100 mg BID | 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 | 10.5 units on a scale | Standard Error 0.98 |
| GLPG0634 100 mg BID | 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 | 11.6 units on a scale | Standard Error 1.1 |
| GLPG0634 100 mg BID | Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24 | MCS at Baseline | 42.059 units on a scale | Standard Error 1.2898 |
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.
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 | Change at Week 4 | -13.1 units on a scale | Standard Error 1.47 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 43.756 units on a scale | Standard Error 1.2717 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -15.8 units on a scale | Standard Error 2 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -8.3 units on a scale | Standard Error 1.25 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -16.3 units on a scale | Standard Error 1.84 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -11.4 units on a scale | Standard Error 1.45 |
| Placebo | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -16.3 units on a scale | Standard Error 1.64 |
| 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 1.3499 |
| 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 | -8 units on a scale | Standard Error 1.14 |
| 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 units on a scale | Standard Error 1.84 |
| 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 | -20.1 units on a scale | Standard Error 1.86 |
| 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 | -16.3 units on a scale | Standard Error 1.64 |
| 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 | -12.5 units on a scale | Standard Error 1.46 |
| 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 | -22.8 units on a scale | Standard Error 2.07 |
| 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 | -18.6 units on a scale | Standard Error 1.64 |
| 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 | -30.1 units on a scale | Standard Error 1.66 |
| 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 | -12.2 units on a scale | Standard Error 1.45 |
| GLPG0634 100 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 45.42 units on a scale | Standard Error 1.3909 |
| 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 | -25.2 units on a scale | Standard Error 1.69 |
| 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 | -22.7 units on a scale | Standard Error 1.78 |
| 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 | -24.6 units on a scale | Standard Error 1.57 |
| 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 | -22.2 units on a scale | Standard Error 1.28 |
| GLPG0634 200 mg QD | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 45.611 units on a scale | Standard Error 1.3362 |
| 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 | -12.8 units on a scale | Standard Error 1.29 |
| 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 | -16.4 units on a scale | Standard Error 1.35 |
| 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 | -25.9 units on a scale | Standard Error 1.57 |
| 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 | -27.2 units on a scale | Standard Error 1.55 |
| 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 | -31 units on a scale | Standard Error 1.66 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -24.9 units on a scale | Standard Error 1.85 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 43.951 units on a scale | Standard Error 1.3224 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -17.8 units on a scale | Standard Error 1.44 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -13.4 units on a scale | Standard Error 1.29 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -8.2 units on a scale | Standard Error 1.17 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -22.3 units on a scale | Standard Error 1.71 |
| GLPG0634 25 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -22.2 units on a scale | Standard Error 1.68 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -27.9 units on a scale | Standard Error 2 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 44.794 units on a scale | Standard Error 1.4043 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -10 units on a scale | Standard Error 1.22 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -23.2 units on a scale | Standard Error 1.8 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -24.5 units on a scale | Standard Error 1.87 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -19.3 units on a scale | Standard Error 1.74 |
| GLPG0634 50 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -15.1 units on a scale | Standard Error 1.43 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 4 | -24.9 units on a scale | Standard Error 1.54 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 8 | -29.2 units on a scale | Standard Error 1.58 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 1 | -14.5 units on a scale | Standard Error 1.31 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 12 | -30.6 units on a scale | Standard Error 1.57 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Baseline | 44.542 units on a scale | Standard Error 1.3097 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 24 | -34.4 units on a scale | Standard Error 1.47 |
| GLPG0634 100 mg BID | Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24 | Change at Week 2 | -20.3 units on a scale | Standard Error 1.35 |
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.
Time frame: Weeks 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 ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 0 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 3.5 percentage of participants |
| Placebo | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 1.2 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 11 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 3.7 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 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 | 1.2 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 3.7 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 3.5 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 1.2 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 3.5 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 3.5 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 8.2 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 0 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 5.8 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 11.6 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 3.5 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 2.3 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 0 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 1.2 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 4.7 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 0 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 5.8 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 4.7 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 3.5 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 0 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 0 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 1.2 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 8 | 3.6 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 12 | 9.5 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 24 | 19 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 2 | 1.2 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24 | Week 4 | 2.4 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: ITT population. Participants who switched treatment at Week 12 were handled as if they discontinued at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Achieving an ACR20 Response at Week 24 | 41.9 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR20 Response at Week 24 | 54.9 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR20 Response at Week 24 | 61.2 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR20 Response at Week 24 | 73.3 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR20 Response at Week 24 | 55.8 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR20 Response at Week 24 | 60 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR20 Response at Week 24 | 79.8 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.
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 24 | 16.3 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 5.8 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 12.8 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 7 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 15.1 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 | 2.4 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 26.8 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 | 35.4 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 | 7.3 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 32.9 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 | 13.4 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 | 37.6 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 32.9 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 | 47.1 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 35.3 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 4.7 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 20 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 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 | 4.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 10.5 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 17.4 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 | 33.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 50 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 25.6 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 7 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 27.9 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 34.9 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 15.1 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 3.5 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 18.8 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 34.1 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 11.8 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 34.1 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 7.1 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 35.3 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 34.5 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 21.4 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 54.8 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 45.2 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 54.8 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 7.1 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.
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 ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 9.3 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 3.5 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 8.1 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 1.2 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 7 percentage of participants |
| Placebo | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.2 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 | 7.3 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 8 | 11 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 | 22 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 | 15.9 percentage of participants |
| GLPG0634 50 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 2.4 percentage of participants |
| GLPG0634 100 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 7.1 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 | 21.2 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 | 32.9 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 | 23.5 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 | 0 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 | 14.1 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 | 29.1 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 | 1.2 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 | 5.8 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 | 4.7 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 18.6 percentage of participants |
| GLPG0634 200 mg QD | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 24.4 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 9.3 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 2.3 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 20.9 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 5.8 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 1.2 percentage of participants |
| GLPG0634 25 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 14 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 9.4 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 18.8 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 14.1 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 5.9 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 23.5 percentage of participants |
| GLPG0634 50 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 2.4 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 2 | 3.6 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 24 | 39.3 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 12 | 31 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 8 | 27.4 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 4 | 10.7 percentage of participants |
| GLPG0634 100 mg BID | Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24 | Week 1 | 4.8 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.
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 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 | 9 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 | 41 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 | 13 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 | 43 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 | 6 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 | 21 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: None | 56 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 | 33 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 | 73 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 24: Good | 19 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 | 34 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 24: Moderate | 34 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 24: None | 48 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 | 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 2: 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 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 12: Moderate | 45 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 | 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 4: Good | 10 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 | 34 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 | 21 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 | 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 2: None | 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 8: Moderate | 45 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 | 6 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 | 45 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 | 1 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 | 35 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 | 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 12: Good | 23 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 | 33 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 | 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 12: None | 33 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 | 61 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 | 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 24: Good | 32 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 | 48 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 | 19 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 | 29 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 | 40 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 | 31 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 | 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 8: Moderate | 52 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 | 28 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 | 18 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 | 42 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 | 34 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 | 12 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 | 38 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 | 51 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 | 58 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 | 35 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 | 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 2: None | 39 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 | 15 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 | 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 4: Moderate | 65 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 2: Moderate | 53 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 | 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 1: Good | 3 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 | 15 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 | 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 1: None | 42 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 | 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 8: Good | 36 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 | 16 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 | 51 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 | 8 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 | 19 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 | 38 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 | 37 percentage of participants |
| GLPG0634 25 mg BID | 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 25 mg BID | 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 | 28 percentage of participants |
| GLPG0634 25 mg BID | 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 | 44 percentage of participants |
| GLPG0634 25 mg BID | 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 | 19 percentage of participants |
| GLPG0634 25 mg BID | 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 | 28 percentage of participants |
| GLPG0634 25 mg BID | 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 | 23 percentage of participants |
| GLPG0634 25 mg BID | 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 | 44 percentage of participants |
| GLPG0634 25 mg BID | 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 | 37 percentage of participants |
| GLPG0634 25 mg BID | 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 | 51 percentage of participants |
| GLPG0634 25 mg BID | 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 | 40 percentage of participants |
| GLPG0634 25 mg BID | 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 | 37 percentage of participants |
| GLPG0634 25 mg BID | 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 25 mg BID | 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 | 34 percentage of participants |
| GLPG0634 25 mg BID | 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 | 6 percentage of participants |
| GLPG0634 25 mg BID | 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 | 43 percentage of participants |
| GLPG0634 25 mg BID | 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 25 mg BID | 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 | 51 percentage of participants |
| GLPG0634 25 mg BID | 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 | 24 percentage of participants |
| GLPG0634 50 mg BID | 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 | 35 percentage of participants |
| GLPG0634 50 mg BID | 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 | 27 percentage of participants |
| GLPG0634 50 mg BID | 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 | 49 percentage of participants |
| GLPG0634 50 mg BID | 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 BID | 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 | 56 percentage of participants |
| GLPG0634 50 mg BID | 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 BID | 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 | 64 percentage of participants |
| GLPG0634 50 mg BID | 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 | 11 percentage of participants |
| GLPG0634 50 mg BID | 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 | 22 percentage of participants |
| GLPG0634 50 mg BID | 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 50 mg BID | 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 | 32 percentage of participants |
| GLPG0634 50 mg BID | 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 | 5 percentage of participants |
| GLPG0634 50 mg BID | 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 | 42 percentage of participants |
| GLPG0634 50 mg BID | 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 | 14 percentage of participants |
| GLPG0634 50 mg BID | 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 | 28 percentage of participants |
| GLPG0634 50 mg BID | 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 50 mg BID | 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 | 15 percentage of participants |
| GLPG0634 50 mg BID | 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 | 49 percentage of participants |
| GLPG0634 100 mg BID | 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 | 45 percentage of participants |
| GLPG0634 100 mg BID | 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 | 49 percentage of participants |
| GLPG0634 100 mg BID | 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 | 43 percentage of participants |
| GLPG0634 100 mg BID | 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 | 50 percentage of participants |
| GLPG0634 100 mg BID | 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 | 24 percentage of participants |
| GLPG0634 100 mg BID | 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 | 64 percentage of participants |
| GLPG0634 100 mg BID | 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 | 46 percentage of participants |
| GLPG0634 100 mg BID | 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 | 11 percentage of participants |
| GLPG0634 100 mg BID | 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 | 31 percentage of participants |
| GLPG0634 100 mg BID | 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 | 62 percentage of participants |
| GLPG0634 100 mg BID | 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 | 40 percentage of participants |
| GLPG0634 100 mg BID | 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 | 8 percentage of participants |
| GLPG0634 100 mg BID | 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 | 61 percentage of participants |
| GLPG0634 100 mg BID | 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 | 18 percentage of participants |
| GLPG0634 100 mg BID | 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 | 7 percentage of participants |
| GLPG0634 100 mg BID | 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 | 20 percentage of participants |
| GLPG0634 100 mg BID | 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 | 15 percentage of participants |
| GLPG0634 100 mg BID | 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 | 5 percentage of participants |