Dosing Flexibility Study in Patients With Rheumatoid Arthritis

Completed · Phase 4 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

During the run-in period, CZP will be administered at 400 mg (2 injections) at Wks 0, 2, and 4 and 200 mg with placebo (1 injection placebo, 1 injection CZP) at Wks 6, 8, 10, 12, 14 and 16. At Wk 18 patients will be grouped as responders or non-responders based on results of the ACR20 at Week 16.

Key facts

Study ID

NCT00580840

Run by

UCB Pharma

People needed

333

Starts

2007-12-01

Expected to finish

2011-03-01

Last updated by the study team

2018-08-02

Who can join

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

You may qualify if…

• Patients with established adult rheumatoid arthritis currently on Methotrexate for at least 3 months

You may not qualify if…

• All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
• Previous clinical trials participation and previous biological therapy that could interfere with the results of the present clinical trial

Where it is running

• Study site — Montgomery, Alabama, United States
• Study site — Gilbert, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Desert, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Aventura, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Bogart, Georgia, United States
• Study site — Morton Grove, Illinois, United States
• Study site — Vernon Hills, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Portland, Maine, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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