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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: March 28, 2008
Last updated: July 18, 2008
Last verified: July 2008
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.

Condition Intervention Phase
Arthritis, Rheumatoid
Drug: valdecoxib
Drug: naproxen
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • ACR-20 criteria responder [ Time Frame: Week 12 ]

Secondary Outcome Measures:
  • Patient's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Duration of morning stiffness [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Incidence and time to withdrawal due to insufficient clinical response [ Time Frame: Study endpoint ]
  • Physician's Global Assessment of Disease Activity [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • swollen joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Adverse events [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • Average rescue medication usage per day [ Time Frame: Study endpoint ]
  • Short Form-36 Acute Health Survey [ Time Frame: Baseline, Week 1, Week 6, and Week 12 ]
  • tender joint count [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • One-Week Severity of Dyspepsia Assessment [ Time Frame: Baseline, Week 1, and Week 12 ]
  • C-reactive protein [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • laboratory tests [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • vital signs [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • physical examinations [ Time Frame: Screening and Week 12 ]
  • ACR-N [ Time Frame: Study endpoint ]
  • Patient Treatment Satisfaction Scale [ Time Frame: Week 1 and Week 6 ]
  • Patient's assessment of arthritis pain (VAS) [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]
  • Health Assessment Questionnaire (HAQ) Disability Index [ Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12 ]

Enrollment: 489
Study Start Date: February 2003
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 2 Drug: naproxen
naproxen 500 mg capsule twice daily for 12 weeks
Placebo Comparator: Arm 3 Drug: placebo
placebo tablet every morning and capsule every evening for 12 weeks
Active Comparator: Arm 1 Drug: valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00650455

  Show 55 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00650455     History of Changes
Other Study ID Numbers: A3471018
Study First Received: March 28, 2008
Last Updated: July 18, 2008

Keywords provided by Pfizer:
valdecoxib, severe rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors processed this record on May 25, 2017