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:
ClinicalTrials.gov 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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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

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
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00650455

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Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00650455     History of Changes
Other Study ID Numbers: A3471018 
Study First Received: March 28, 2008
Last Updated: July 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
valdecoxib, severe rheumatoid arthritis

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

ClinicalTrials.gov processed this record on May 24, 2016