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

Phase 4

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: placebo; Drug: naproxen; Drug: valdecoxib

• Registration Number: NCT00650455
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Study First Submitted: 2008-03-28
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-04-01
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-18
• Last Update Posted: 2008-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3	placebo	-
Arm 2	naproxen	-
Arm 1	valdecoxib	-

Primary Outcome Measures

Name	Time	Method
ACR-20 criteria responder	Week 12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Saskatoon, Saskatchewan, Canada