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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00425321 | Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy | PHASE2 | COMPLETED | 259 | — | — | Dec 1, 2006 | Jan 1, 2008 | May 21, 2014 | 42 | United States, Argentina +5 |
| Arm | Type | Description |
|---|---|---|
| RWJ-445380 100 mg | EXPERIMENTAL | - |
| RWJ-445380 200 mg | EXPERIMENTAL | - |
| RWJ-445380 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| RWJ-445380 100 mg | DRUG | RWJ-445380 100 mg once daily for up to 12 weeks |
| RWJ-445380 200 mg | DRUG | RWJ-445380 200 mg once daily for up to 12 weeks |
| RWJ-445380 300 mg | DRUG | RWJ-445380 300 mg once daily for up to 12 weeks |
| Placebo | DRUG | Placebo once daily for up to 12 weeks |
Inclusion Criteria: * Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints * methotrexate treatment for 6 months * at least 10mg/wk and stable dose for at least 8 weeks * negative TB screening Exclusion Criteria: * Use of other disease-mod...