Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients

Completed · Phase 4 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.

Key facts

Study ID

NCT00650455

Run by

Pfizer

People needed

489

Starts

2003-02-01

Expected to finish

2005-01-01

Last updated by the study team

2008-07-21

Who can join

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

You may qualify if…

• A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
• The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)

You may not qualify if…

• A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from the study

Where it is running

• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Glendale, Arizona, United States
• Pfizer Investigational Site — Mesa, Arizona, United States
• Pfizer Investigational Site — Paradise Valley, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Scottsdale, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Fullerton, California, United States
• Pfizer Investigational Site — Rancho Mirage, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Fort Lauderdale, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jupiter, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Orlando, Florida, United States
• Pfizer Investigational Site — Palm Harbor, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — West Palm Beach, Florida, United States
• Pfizer Investigational Site — Zephyrhills, Florida, United States
• Pfizer Investigational Site — Idaho Falls, Idaho, United States
• Pfizer Investigational Site — Chicago, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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