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Completed

NCT Number: NCT00650455

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

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.

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Key information

Conditions

Arthritis, Rheumatoid Arthritis Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Winnipeg, Manitoba, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valdecoxib

Drug

valdecoxib 10 mg tablet once daily for 12 weeks

Naproxen

Drug

naproxen 500 mg capsule twice daily for 12 weeks

Placebo

Drug

placebo tablet every morning and capsule every evening for 12 weeks

Primary outcomes

  1. ACR-20 criteria responder

    Time frame: Week 12

Secondary outcomes

  1. Patient's Global Assessment of Disease Activity

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  2. Duration of morning stiffness

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  3. Incidence and time to withdrawal due to insufficient clinical response

    Time frame: Study endpoint

  4. Physician's Global Assessment of Disease Activity

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  5. swollen joint count

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  6. Adverse events

    Time frame: Baseline, Week 1, Week 6, and Week 12

  7. Average rescue medication usage per day

    Time frame: Study endpoint

  8. Short Form-36 Acute Health Survey

    Time frame: Baseline, Week 1, Week 6, and Week 12

  9. tender joint count

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  10. One-Week Severity of Dyspepsia Assessment

    Time frame: Baseline, Week 1, and Week 12

  11. C-reactive protein

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  12. laboratory tests

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  13. vital signs

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  14. physical examinations

    Time frame: Screening and Week 12

  15. ACR-N

    Time frame: Study endpoint

  16. Patient Treatment Satisfaction Scale

    Time frame: Week 1 and Week 6

  17. Patient's assessment of arthritis pain (VAS)

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

  18. Health Assessment Questionnaire (HAQ) Disability Index

    Time frame: Screening, Baseline, Week 1, Week 6, and Week 12

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 1, 2008
Registry last updated
Jul 21, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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