Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Population

Condition(s) targeted: Arthritis, Rheumatoid

Intervention: valdecoxib (Drug); naproxen (Drug); placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: ACR-20 criteria responder

Secondary outcome:

swollen joint count

Adverse events

Average rescue medication usage per day

Short Form-36 Acute Health Survey

tender joint count

One-Week Severity of Dyspepsia Assessment

ACR-20 criteria responder

ACR-N

C-reactive protein

laboratory tests

vital signs

physical examinations

Patient's assessment of arthritis pain (VAS)

Physician's Global Assessment of Disease Activity

Health Assessment Questionnaire (HAQ) Disability Index

Patient's Global Assessment of Disease Activity

Duration of morning stiffness

Incidence and time to withdrawal due to insufficient clinical response

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- A diagnosis of severe rheumatoid artrhitis (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) (for at least 4 weeks) as well as at least one of the following with the dosing regimen stable for the indicated time: methotrexate (doses up to 25 mg per week) for 30 days, cyclosporine for at least 12 weeks, leflunomide (Arava®) for at least 12 weeks, interleukin-1 receptor antagonist anakinra (Kineret®) for at least 12 weeks, or one of the several other tumor necrosis factor inhibitors (i. e., adalimumad [Humira®] for a minimum of 5 doses on a regular schedule, entanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)

Exclusion Criteria:

- 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

Pfizer Investigational Site, HUNTSVILLE, Alabama 35801, United States

Pfizer Investigational Site, BIRMINGHAM, Alabama 35249-7201, United States

Pfizer Investigational Site, GLENDALE, Arizona 85304, United States

Pfizer Investigational Site, MESA, Arizona 85202, United States

Pfizer Investigational Site, PARADISE VALLEY, Arizona 85253, United States

Pfizer Investigational Site, SCOTTSDALE, Arizona 95260, United States

Pfizer Investigational Site, PHOENIX, Arizona 85012, United States

Pfizer Investigational Site, GLENDALE, Arizona 85308, United States

Pfizer Investigational Site, Tucson, Arizona 85719, United States

Pfizer Investigational Site, RANCHO MIRAGE, California 92270, United States

Pfizer Investigational Site, Rancho Mirage, California 92270, United States

Pfizer Investigational Site, FULLERTON, California 92835, United States

Pfizer Investigational Site, SAN DIEGO, California 92120, United States

Pfizer Investigational Site, OCALA, Florida 34474, United States

Pfizer Investigational Site, Tampa, Florida 33614, United States

Pfizer Investigational Site, ORLANDO, Florida 32804, United States

Pfizer Investigational Site, Fort Lauderdale, Florida 33334, United States

Pfizer Investigational Site, ZEPHYRHILLS, Florida 33540, United States

Pfizer Investigational Site, PALM HARBOR, Florida 34684, United States

Pfizer Investigational Site, Jacksonville, Florida 32204, United States

Pfizer Investigational Site, WEST PALM BEACH, Florida 33401, United States

Pfizer Investigational Site, Jupiter, Florida 33458, United States

Pfizer Investigational Site, IDAHO FALLS, Idaho 83404, United States

Pfizer Investigational Site, SPRINGFIELD, Illinois 62704, United States

Pfizer Investigational Site, CHICAGO, Illinois 60612, United States

Pfizer Investigational Site, Indianapolis, Indiana 46227, United States

Pfizer Investigational Site, Winnipeg, Manitoba R3A 1M1, Canada

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, NEW YORK, New York 10021, United States

Pfizer Investigational Site, NEW YORK, New York 10035, United States

Pfizer Investigational Site, BROOKLYN, New York 11203, United States

Pfizer Investigational Site, NEW YORK, New York 10021, United States

Pfizer Investigational Site, COLUMBUS, Ohio 43214, United States

Pfizer Investigational Site, Windsor, Ontario N8W 5L7, Canada

Pfizer Investigational Site, DUNCANSVILLE, Pennsylvania 16635, United States

Pfizer Investigational Site, JOHNSTOWN, Pennsylvania 15904, United States

Pfizer Investigational Site, PHILADELPHIA, Pennsylvania 19102, United States

Pfizer Investigational Site, PHILADEPHIA, Pennsylvania 19152, United States

Pfizer Investigational Site, MECHANICSBURG, Pennsylvania 17055, United States

Pfizer Investigational Site, ALLENTOWN, Pennsylvania 18103, United States

Pfizer Investigational Site, ERIE, Pennsylvania 16508, United States

Pfizer Investigational Site, PROVIDENCE, Rhode Island 02906, United States

Pfizer Investigational Site, Saskatoon, Saskatchewan S7K 0H6, Canada

Pfizer Investigational Site, SAN ANTONIO, Texas 78240, United States

Pfizer Investigational Site, FORT WORTH, Texas 76107, United States

Pfizer Investigational Site, EL PASO, Texas 79902, United States

Pfizer Investigational Site, DALLAS, Texas 75246, United States

Pfizer Investigational Site, PLANO, Texas 75093, United States

Pfizer Investigational Site, San Antonio, Texas 78232, United States

Pfizer Investigational Site, Arlington, Virginia 22204, United States

Pfizer Investigational Site, Seattle, Washington 98166-2967, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: February 2003
Ending date: January 2005
Last updated: April 7, 2008