Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population
1 other identifier
interventional
489
2 countries
55
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2003
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 1, 2008
CompletedJuly 21, 2008
July 1, 2008
1.9 years
March 28, 2008
July 18, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR-20 criteria responder
Week 12
Secondary Outcomes (18)
Patient's Global Assessment of Disease Activity
Screening, Baseline, Week 1, Week 6, and Week 12
Duration of morning stiffness
Screening, Baseline, Week 1, Week 6, and Week 12
Incidence and time to withdrawal due to insufficient clinical response
Study endpoint
Physician's Global Assessment of Disease Activity
Screening, Baseline, Week 1, Week 6, and Week 12
swollen joint count
Screening, Baseline, Week 1, Week 6, and Week 12
- +13 more secondary outcomes
Study Arms (3)
Arm 2
ACTIVE COMPARATORArm 3
PLACEBO COMPARATORArm 1
ACTIVE COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (55)
Pfizer Investigational Site
Birmingham, Alabama, 35249-7201, United States
Pfizer Investigational Site
Huntsville, Alabama, 35801, United States
Pfizer Investigational Site
Glendale, Arizona, 85304, United States
Pfizer Investigational Site
Glendale, Arizona, 85308, United States
Pfizer Investigational Site
Mesa, Arizona, 85202, United States
Pfizer Investigational Site
Paradise Valley, Arizona, 85253, United States
Pfizer Investigational Site
Phoenix, Arizona, 85012, United States
Pfizer Investigational Site
Scottsdale, Arizona, 95260, United States
Pfizer Investigational Site
Tucson, Arizona, 85719, United States
Pfizer Investigational Site
Fullerton, California, 92835, United States
Pfizer Investigational Site
Rancho Mirage, California, 92270, United States
Pfizer Investigational Site
San Diego, California, 92120, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, 33334, United States
Pfizer Investigational Site
Jacksonville, Florida, 32204, United States
Pfizer Investigational Site
Jupiter, Florida, 33458, United States
Pfizer Investigational Site
Ocala, Florida, 34474, United States
Pfizer Investigational Site
Orlando, Florida, 32804, United States
Pfizer Investigational Site
Palm Harbor, Florida, 34684, United States
Pfizer Investigational Site
Tampa, Florida, 33614, United States
Pfizer Investigational Site
West Palm Beach, Florida, 33401, United States
Pfizer Investigational Site
Zephyrhills, Florida, 33540, United States
Pfizer Investigational Site
Idaho Falls, Idaho, 83404, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Springfield, Illinois, 62704, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46227, United States
Pfizer Investigational Site
Frederick, Maryland, 21702, United States
Pfizer Investigational Site
Greenbelt, Maryland, 20770, United States
Pfizer Investigational Site
Lansing, Michigan, 48910, United States
Pfizer Investigational Site
Jackson, Mississippi, 39216, United States
Pfizer Investigational Site
Marlton, New Jersey, 8053, United States
Pfizer Investigational Site
Passaic, New Jersey, 07055, United States
Pfizer Investigational Site
Teaneck, New Jersey, 07666, United States
Pfizer Investigational Site
Brooklyn, New York, 11203, United States
Pfizer Investigational Site
New York, New York, 10021, United States
Pfizer Investigational Site
New York, New York, 10035, United States
Pfizer Investigational Site
Columbus, Ohio, 43214, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18103, United States
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635, United States
Pfizer Investigational Site
Erie, Pennsylvania, 16508, United States
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904, United States
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19102, United States
Pfizer Investigational Site
Philadephia, Pennsylvania, 19152, United States
Pfizer Investigational Site
Providence, Rhode Island, 02906, United States
Pfizer Investigational Site
Dallas, Texas, 75246, United States
Pfizer Investigational Site
El Paso, Texas, 79902, United States
Pfizer Investigational Site
Fort Worth, Texas, 76107, United States
Pfizer Investigational Site
Plano, Texas, 75093, United States
Pfizer Investigational Site
San Antonio, Texas, 78232, United States
Pfizer Investigational Site
San Antonio, Texas, 78240, United States
Pfizer Investigational Site
Arlington, Virginia, 22204, United States
Pfizer Investigational Site
Seattle, Washington, 98166-2967, United States
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M1, Canada
Pfizer Investigational Site
Windsor, Ontario, N8W 5L7, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2008
First Posted
April 1, 2008
Study Start
February 1, 2003
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
July 21, 2008
Record last verified: 2008-07