Arthritis, Rheumatoid
Conditions
Keywords
valdecoxib, severe rheumatoid arthritis
Brief summary
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.
Interventions
DRUGplacebo
placebo tablet every morning and capsule every evening for 12 weeks
DRUGvaldecoxib
valdecoxib 10 mg tablet once daily for 12 weeks
DRUGnaproxen
naproxen 500 mg capsule twice daily for 12 weeks
Sponsors
Pfizer
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR-20 criteria responder | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Patient's Global Assessment of Disease Activity | Screening, Baseline, Week 1, Week 6, 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 |
| One-Week Severity of Dyspepsia Assessment | Baseline, Week 1, and Week 12 |
Countries
Canada, United States
Outcome results
None listed