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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01211249 | GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis | PHASE2 | COMPLETED | 30 | — | — | Oct 1, 2010 | Apr 1, 2011 | Apr 26, 2011 | 32 | Belgium, Netherlands +3 |
The primary efficacy endpoint will be the number and percentage of subjects in each GLPG0259 dose group and placebo group achieving an American College of Rheumatology (ACR)20 (ACR20 response rate) at Week 12.
| Arm | Type | Description |
|---|---|---|
| GLPG0259 (Part A) | EXPERIMENTAL | - |
| Placebo (Part A) | PLACEBO_COMPARATOR | - |
| GLPG0259 (Part B) | EXPERIMENTAL | - |
| Placebo (Part B) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| GLPG0259 oral capsule | DRUG | Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule) |
| Placebo | DRUG | Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule |
| GLPG0259 (Part B) | DRUG | Capsule, dosage to be established based on results of Part A |
| Placebo (Part B) | DRUG | Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B) |
Inclusion Criteria: * Must have active RA (≥5 tender or painful joints on motion and ≥5 joints swollen AND a C-reactive protein (CRP) concentration ≥1.5 mg/dL). * Must have been on methotrexate for ≥6 months at a stable dose of 7.5-25 mg/week for ≥12 weeks, to be continued throughout study; * If on...