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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00550446 | A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis | PHASE2 | COMPLETED | 386 | — | — | Sep 1, 2007 | Jan 1, 2009 | Jan 3, 2013 | 63 | United States, Brazil +13 |
ACR20 response: greater than or equal to (\>=) 20 % improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | EXPERIMENTAL | - |
| 5 | EXPERIMENTAL | - |
| 6 | EXPERIMENTAL | - |
| 7 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Adalimumab | DRUG | 40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12. |
| CP-690-550 | DRUG | 15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10) |
| CP-690,550 | DRUG | 3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10) |
| Placebo | DRUG | Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10) |
Inclusion Criteria: * Subjects must have active rheumatoid arthritis * Subjects must have failed at least 1 disease modifying anti-rheumatic drug (DMARD) * Subjects must not be currently taking any DMARD other than an antimalarial Exclusion Criteria: * Subjects who discontinued any previous TNF i...