Status:
COMPLETED
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT00650455
Start Date
February 1 2003
End Date
January 1 2005
Last Update
July 21 2008
Active Locations (55)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35249-7201
2
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
3
Pfizer Investigational Site
Glendale, Arizona, United States, 85304
4
Pfizer Investigational Site
Glendale, Arizona, United States, 85308