A Study of P38 Inhibitor (4) Monotherapy in Patients With Active Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 4 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of P38 Inhibitor (4) (50, 150 or 300mg po qd) monotherapy versus methotrexate monotherapy in adult patients with active rheumatoid arthritis. Patients will be randomized to receive one of 3 doses of P38 Inhibitor (4) or methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00303563

Run by

Hoffmann-La Roche

People needed

204

Starts

2006-04-01

Expected to finish

2007-12-01

Last updated by the study team

2016-11-02

Who can join

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

You may qualify if…

• adult patients >18 years of age, with active RA;
• receiving treatment for RA on an outpatient basis;
• females of child-bearing potential, or nonsterilized males with partners of child-bearing potential, must use reliable contraception during, and for 4 weeks after, the study.

You may not qualify if…

• major surgery within 8 weeks prior to screening;
• rheumatic autoimmune disease or inflammatory joint disease other than RA;
• treatment with methotrexate within 8 weeks of baseline;
• concurrent use of DMARDs, including anti-TNF or other biologic therapy for RA.

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Escondido, California, United States
• Study site — Loma Linda, California, United States
• Study site — Stamford, Connecticut, United States
• Study site — Morton Grove, Illinois, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Belmont, North Carolina, United States
• Study site — Bend, Oregon, United States
• Study site — Danville, Pennsylvania, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Knoxville, Tennessee, United States
• Study site — Memphis, Tennessee, United States
• Study site — Nashville, Tennessee, United States
• Study site — Amarillo, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Halifax, Nova Scotia, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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