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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00425321

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

259

Starts

2006-12-01

Expected to finish

2008-01-01

Last updated by the study team

2014-05-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Fair Oaks, California, United States
• Study site — Whittier, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Sarasota, Florida, United States
• Study site — Morton Grove, Illinois, United States
• Study site — Springfield, Illinois, United States
• Study site — Frederick, Maryland, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Buenos Aires, Argentina
• Study site — Federal, Argentina
• Study site — Luján, Argentina
• Study site — Curitiba, Brazil
• Study site — Porto Alegre, Brazil
• Study site — São Paulo, Brazil
• Study site — Brno, Czechia
• Study site — Plzeò 1, Czechia
• Study site — Prague, Czechia
• Study site — Uherské Hradiště, Czechia
• Study site — Zlín, Czechia
• Study site — Bad Abbach, Germany

Full record on ClinicalTrials.gov

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