Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the safety and tolerability of 100, 200, and 300 mg/day doses of RWJ-445380 for up to 12 weeks in patients with active Rheumatoid Arthritis despite methotrexate therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Methotrexate

Criteria

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-modifying anti-rheumatic drugs (DMARDs) (other than Methotrexate MTX)

• previous use of more than 1 anti-TNF (tumor necrosis factor) agent

• previous use of cytotoxics, p38 MAPkinase inhibitor, anti-CD4 antibody

• receipt of live vaccine within 1 month of study drug

• serious infection in previous 2 months or history of chronic or recurrent infectious disease or history of opportunistic infection

• other clinically significant disease of other organ system