Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RWJ-445380 · 1 trial · 1 indication
| 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...
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RWJ-445380 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in patients with active rheumatoid arthritis who were already receiving methotrexate therapy. The drug is not approved and remains in clinical development.
RWJ-445380 is a cathepsin-S inhibitor. Cathepsin-S is an enzyme involved in antigen presentation and immune response, and inhibiting it is being studied as a potential approach to treat rheumatoid arthritis.
RWJ-445380 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ.
RWJ-445380 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
RWJ-445380 has been studied in one completed Phase 2 trial, NCT00425321, which enrolled 259 participants with active rheumatoid arthritis despite methotrexate therapy. The trial was randomized, double-blind, and placebo-controlled, and took place in the United States, Argentina, Brazil, Czechia, Germany, Mexico, and Poland.