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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01909427 | An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy | PHASE2 | COMPLETED | 257 | — | — | Jun 1, 2013 | May 1, 2015 | Mar 2, 2016 | 32 | Argentina, Colombia +5 |
American College of Rheumatology (ACR) 20 response is a \>=20% improvement in rheumatoid arthritis (RA) symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo/CNTO 6785 200 mg+Methotrexate (MTX) | PLACEBO_COMPARATOR | - |
| CNTO 6785 200 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 100 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 50 mg+MTX | EXPERIMENTAL | - |
| CNTO 6785 15 mg+MTX | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo subcutaneous injections (SC) every 4 weeks through Week 12 |
| CNTO 6785 200 mg | DRUG | CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28 |
| CNTO 6785 100 mg | DRUG | CNTO 6785 100 mg SC every 4 weeks through Week 28 |
| CNTO 6785 50 mg | DRUG | CNTO 6785 50 mg SC every 4 weeks through Week 28 |
| CNTO 6785 15 mg | DRUG | CNTO 6785 15 mg SC every 4 weeks through Week 28 |
| Methotrexate (MTX) | DRUG | MTX at the same stable dose through Week 32, that participants were receiving prior to screening. |
Inclusion Criteria: * Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening * Have active RA defined study as persistent disea...