Status:
COMPLETED
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 me...
Detailed Description
Trials with a new, first -in-class drug will be done to ascertain safety, tolerability, and to explore efficacy in the treatment of rheumatoid arthritis, including its effects on biomarkers. Approxima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT00425321
Start Date
December 1 2006
End Date
January 1 2008
Last Update
May 21 2014
Active Locations (42)
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1
Birmingham, Alabama, United States
2
Huntsville, Alabama, United States
3
Tucson, Arizona, United States
4
Fair Oaks, California, United States