A Study of P38 Inhibitor (4) in Patients With Active Rheumatoid Arthritis (RA) on Stable Methotrexate Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This 6 arm study will evaluate the efficacy and safety of different doses of P38 Inhibitor (4) in patients with RA currently having an inadequate clinical response to methotrexate. Patients will be randomized to receive P38 Inhibitor (4) (50,150 or 300 qd po,and 25 or 75 bid po) or placebo, and will remain on the stable dose of methotrexate. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00316771

Run by

Hoffmann-La Roche

People needed

374

Starts

2005-11-01

Expected to finish

2008-03-01

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;
• active rheumatoid arthritis;
• current inadequate clinical response to methotrexate.

You may not qualify if…

• receiving any other disease-modifying anti-rheumatic drug, with the exception of hydroxychloroquine or chloroquine.

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Escondido, California, United States
• Study site — Fair Oaks, California, United States
• Study site — Loma Linda, California, United States
• Study site — Riverside, California, United States
• Study site — Upland, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Tamarac, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Macon, Georgia, United States
• Study site — Nampa, Idaho, United States
• Study site — Munster, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Wichita, Kansas, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Traverse City, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.