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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00202852 | A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED) | PHASE3 | COMPLETED | 143 | — | — | Jun 1, 2005 | Mar 1, 2006 | Mar 24, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX |
| MTX | DRUG | Placebo infusions at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX; MTX dose \>=12.5 mg/week given orally or parenterally, maximum 20 mg/week |
| Infliximab | BIOLOGICAL | Infliximab 3 mg/kg given as an infusion at Weeks 0, 2, and 6 and every 8 weeks through Week 22 + MTX |
Inclusion Criteria: * Diagnosis of RA according to the revised 1987 criteria of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening. * Active disease at the time of screening and pre-infusion as defined by: * \>=6 ...