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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00727987 | A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | PHASE3 | COMPLETED | 269 | — | — | May 1, 2008 | Dec 1, 2011 | May 23, 2013 | 65 | Japan |
| NCT00771251 | A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA) | PHASE3 | COMPLETED | 311 | — | — | May 1, 2008 | Oct 1, 2011 | Nov 3, 2015 | 67 | Japan |
| Arm | Type | Description |
|---|---|---|
| CNTO 148 50 mg + methotrexate | EXPERIMENTAL | - |
| CNTO 148 100 mg + methotrexate | EXPERIMENTAL | - |
| Placebo + methotrexate | PLACEBO_COMPARATOR | - |
| CNTO 148 50 mg | EXPERIMENTAL | - |
| CNTO 148 100 mg | EXPERIMENTAL | - |
| Placebo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CNTO 148 | DRUG | 50 mg or 100 mg given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 152. |
| Placebo | DRUG | Placebo identical in appearance to CNTO 148 given as a subcutaneous (under the skin) injection once every 4 weeks up to Week 24. |
| Methotrexate (MTX) | DRUG | 6 mg/week to 8 mg/week taken orally (by mouth) from at least 4 weeks before the initial investigational treatment to the completion of assessment at Week 52. |
Inclusion Criteria: * Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatol...