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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: valdecoxib
* Drug: naproxen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 2<br> | Drug: naproxen<br>* naproxen 500 mg capsule twice daily for 12 weeks<br>|
| Placebo Comparator: Arm 3<br> | Drug: placebo<br>* placebo tablet every morning and capsule every evening for 12 weeks<br>|
| Active Comparator: Arm 1<br> | Drug: valdecoxib<br>* valdecoxib 10 mg tablet once daily for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR-20 criteria responder |  | Week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valdecoxib, severe rheumatoid arthritis