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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01975610 | Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis | PHASE2 | COMPLETED | 47 | — | — | Oct 1, 2013 | Feb 1, 2016 | Jul 31, 2017 | 27 | United States |
Percentage of participants with an American College of Rheumatology ≥20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from Baseline are met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: o Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); o Patient's global assessment of disease activity (measured on a 100 mm VAS); o Physician's global assessment of disease activity (measured on a 100 mm VAS); o Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index (HAQ-DI)); o C-Reactive Protein
| Arm | Type | Description |
|---|---|---|
| CC-292 375mg | EXPERIMENTAL | Treatment |
| Placebo | PLACEBO_COMPARATOR | Control |
| Name | Type | Description |
|---|---|---|
| CC-292 | DRUG | 375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days) |
| Placebo | DRUG | Twice daily for 28 days |
Inclusion Criteria: * Female between 18 and 80 years of age (inclusive) at the time of signing the informed consent. * Must meet the 2010 ACR/EULAR Classification Criteria for RA (Appendix A), have RA for at least 6 months and must continue to have active RA at the time of randomization despite at ...