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NCT00650455 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00650455
Other study ID # A3471018
Secondary ID
Status Completed
Phase Phase 4
First received March 28, 2008
Last updated July 18, 2008
Start date February 2003
Est. completion date January 2005

Study information
Verified date July 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 489
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks
• naproxen
naproxen 500 mg capsule twice daily for 12 weeks
• placebo
placebo tablet every morning and capsule every evening for 12 weeks

Locations
Country Name City State
Canada Pfizer Investigational Site Saskatoon Saskatchewan
Canada Pfizer Investigational Site Windsor Ontario
Canada Pfizer Investigational Site Winnipeg Manitoba
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Arlington Virginia
United States Pfizer Investigational Site Birmingham Alabama
United States Pfizer Investigational Site Brooklyn New York
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Duncansville Pennsylvania
United States Pfizer Investigational Site El Paso Texas
United States Pfizer Investigational Site Erie Pennsylvania
United States Pfizer Investigational Site Fort Lauderdale Florida
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Frederick Maryland
United States Pfizer Investigational Site Fullerton California
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Glendale Arizona
United States Pfizer Investigational Site Greenbelt Maryland
United States Pfizer Investigational Site Huntsville Alabama
United States Pfizer Investigational Site Idaho Falls Idaho
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Jackson Mississippi
United States Pfizer Investigational Site Jacksonville Florida
United States Pfizer Investigational Site Johnstown Pennsylvania
United States Pfizer Investigational Site Jupiter Florida
United States Pfizer Investigational Site Lansing Michigan
United States Pfizer Investigational Site Marlton New Jersey
United States Pfizer Investigational Site Mechanicsburg Pennsylvania
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
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 Paradise Valley Arizona
United States Pfizer Investigational Site Passaic New Jersey
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Philadephia Pennsylvania
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Plano Texas
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Rancho Mirage California
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Scottsdale Arizona
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Springfield Illinois
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Teaneck New Jersey
United States Pfizer Investigational Site Tucson Arizona
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site Zephyrhills Florida

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary ACR-20 criteria responder Week 12 No
Secondary Patient's Global Assessment of Disease Activity Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary Duration of morning stiffness Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary Incidence and time to withdrawal due to insufficient clinical response Study endpoint No
Secondary Physician's Global Assessment of Disease Activity Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary swollen joint count Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary Adverse events Baseline, Week 1, Week 6, and Week 12 Yes
Secondary Average rescue medication usage per day Study endpoint No
Secondary Short Form-36 Acute Health Survey Baseline, Week 1, Week 6, and Week 12 No
Secondary tender joint count Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary One-Week Severity of Dyspepsia Assessment Baseline, Week 1, and Week 12 No
Secondary C-reactive protein Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary laboratory tests Screening, Baseline, Week 1, Week 6, and Week 12 Yes
Secondary vital signs Screening, Baseline, Week 1, Week 6, and Week 12 Yes
Secondary physical examinations Screening and Week 12 Yes
Secondary ACR-N Study endpoint No
Secondary Patient Treatment Satisfaction Scale Week 1 and Week 6 No
Secondary Patient's assessment of arthritis pain (VAS) Screening, Baseline, Week 1, Week 6, and Week 12 No
Secondary Health Assessment Questionnaire (HAQ) Disability Index Screening, Baseline, Week 1, Week 6, and Week 12 No
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Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2

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