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”

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.

Study Type: Interventional

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

Study Primary Completion Date: January 2005

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 2
• Placebo Comparator: Arm 3
• Active Comparator: Arm 1

Primary Measures

• ACR-20 criteria responder
  • Time Frame: Week 12
    Safety Issue?: No

Secondary Measures

• Patient's Global Assessment of Disease Activity
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• Duration of morning stiffness
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• Incidence and time to withdrawal due to insufficient clinical response
  • Time Frame: Study endpoint
    Safety Issue?: No
• Physician's Global Assessment of Disease Activity
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• swollen joint count
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• Adverse events
  • Time Frame: Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: Yes
• Average rescue medication usage per day
  • Time Frame: Study endpoint
    Safety Issue?: No
• Short Form-36 Acute Health Survey
  • Time Frame: Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• tender joint count
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• One-Week Severity of Dyspepsia Assessment
  • Time Frame: Baseline, Week 1, and Week 12
    Safety Issue?: No
• C-reactive protein
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• laboratory tests
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: Yes
• vital signs
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: Yes
• physical examinations
  • Time Frame: Screening and Week 12
    Safety Issue?: Yes
• ACR-N
  • Time Frame: Study endpoint
    Safety Issue?: No
• Patient Treatment Satisfaction Scale
  • Time Frame: Week 1 and Week 6
    Safety Issue?: No
• Patient's assessment of arthritis pain (VAS)
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No
• Health Assessment Questionnaire (HAQ) Disability Index
  • Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00650455

Study ID Number: A3471018

ClinicalTrials.gov Identifier: NCT00650455

Health Authority: United States: Food and Drug Administration

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