Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01894516 | Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2) | PHASE2 | COMPLETED | 287 | — | — | Oct 8, 2013 | May 29, 2015 | Dec 16, 2020 | 82 | United States, Argentina +17 |
| NCT01888874 | Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) | PHASE2 | COMPLETED | 599 | — | — | Jul 17, 2013 | May 14, 2015 | Nov 17, 2020 | 142 | United States, Argentina +20 |
| NCT01668641 | Dose-ranging Study With GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | PHASE2 | COMPLETED | 91 | — | — | May 1, 2012 | Oct 1, 2012 | Jun 27, 2013 | 19 | Hungary, Moldova +2 |
| NCT01384422 | Safety and Preliminary Efficacy of GLPG0634 in Methotrexate-refractory Active Rheumatoid Arthritis Patients | PHASE2 | COMPLETED | 36 | — | — | Jun 1, 2011 | Nov 1, 2011 | Aug 15, 2012 | 1 | Moldova |
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).
To preliminary evaluate the efficacy of GLPG0634 compared to placebo in terms of the proportion of subjects achieving an ACR20 response at Week 4
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24. |
| GLPG0634 50 mg QD | EXPERIMENTAL | Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24. |
| GLPG0634 100 mg QD | EXPERIMENTAL | Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24. |
| GLPG0634 200 mg QD | EXPERIMENTAL | Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24. |
| GLPG0634 25 mg BID | EXPERIMENTAL | 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. |
| GLPG0634 50 mg BID | EXPERIMENTAL | Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24. |
| GLPG0634 100 mg BID | EXPERIMENTAL | Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24. |
| capsule, 30mg GLPG0634 once a day | EXPERIMENTAL | 3 capsules of 10 mg once a day |
| capsules, 75mg GLPG0634 once a day | EXPERIMENTAL | 3 capsules of 25mg once a day |
| capsules, 150mg GLPG0634 once a day | EXPERIMENTAL | 3 capsules of 50mg once a day |
| capsules, 300mg GLPG0634 once a day | EXPERIMENTAL | 3 capsules of 100mg once a day |
| capsules, placebo once a day | PLACEBO_COMPARATOR | 3 capsules placebo once a day |
| GLPG0634 100 mg bid oral capsules | EXPERIMENTAL | - |
| GLPG0634 200 mg qd oral capsules | EXPERIMENTAL | - |
| Placebo oral capsules | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GLPG0634 | DRUG | GLPG0634 capsules. |
| Placebo | DRUG | Placebo capsules. |
Inclusion Criteria: * male or female subjects who are ≥18 years of age on the day of signing informed consent, * have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III, * have ≥6 swollen joints (from a 66-joint count) and ≥8 te...