Clinical trial NCT00650455: Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: valdecoxib, severe rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 489
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ACR-20 criteria responder
timeFrame: Week 12
Secondary outcomes:
measure: Patient's Global Assessment of Disease Activity
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: Duration of morning stiffness
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: Incidence and time to withdrawal due to insufficient clinical response
timeFrame: Study endpoint
measure: Physician's Global Assessment of Disease Activity
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: swollen joint count
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: Adverse events
timeFrame: Baseline, Week 1, Week 6, and Week 12
measure: Average rescue medication usage per day
timeFrame: Study endpoint
measure: Short Form-36 Acute Health Survey
timeFrame: Baseline, Week 1, Week 6, and Week 12
measure: tender joint count
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: One-Week Severity of Dyspepsia Assessment
timeFrame: Baseline, Week 1, and Week 12
measure: C-reactive protein
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: laboratory tests
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: vital signs
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: physical examinations
timeFrame: Screening and Week 12
measure: ACR-N
timeFrame: Study endpoint
measure: Patient Treatment Satisfaction Scale
timeFrame: Week 1 and Week 6
measure: Patient's assessment of arthritis pain (VAS)
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
measure: Health Assessment Questionnaire (HAQ) Disability Index
timeFrame: Screening, Baseline, Week 1, Week 6, and Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Paradise Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Fullerton
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Lauderdale
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Idaho Falls
country: United States
facility: Pfizer Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Frederick
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Greenbelt
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Marlton
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Passaic
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Teaneck
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Brooklyn
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Erie
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadephia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Providence
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Plano
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Arlington
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: