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
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
489
valdecoxib 10 mg tablet once daily for 12 weeks
naproxen 500 mg capsule twice daily for 12 weeks
placebo tablet every morning and capsule every evening for 12 weeks
ACR-20 criteria responder
Time frame: Week 12
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
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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