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

July 18, 2008 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

489

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M1
        • Pfizer Investigational Site
    • Ontario
      • Windsor, Ontario, Canada, N8W 5L7
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 0H6
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-7201
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Pfizer Investigational Site
      • Glendale, Arizona, United States, 85304
        • Pfizer Investigational Site
      • Mesa, Arizona, United States, 85202
        • Pfizer Investigational Site
      • Paradise Valley, Arizona, United States, 85253
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85012
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 95260
        • Pfizer Investigational Site
      • Tucson, Arizona, United States, 85719
        • Pfizer Investigational Site
    • California
      • Fullerton, California, United States, 92835
        • Pfizer Investigational Site
      • Rancho Mirage, California, United States, 92270
        • Pfizer Investigational Site
      • San Diego, California, United States, 92120
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33334
        • Pfizer Investigational Site
      • Jacksonville, Florida, United States, 32204
        • Pfizer Investigational Site
      • Jupiter, Florida, United States, 33458
        • Pfizer Investigational Site
      • Ocala, Florida, United States, 34474
        • Pfizer Investigational Site
      • Orlando, Florida, United States, 32804
        • Pfizer Investigational Site
      • Palm Harbor, Florida, United States, 34684
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33614
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • Pfizer Investigational Site
      • Zephyrhills, Florida, United States, 33540
        • Pfizer Investigational Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Springfield, Illinois, United States, 62704
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Pfizer Investigational Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Pfizer Investigational Site
      • Greenbelt, Maryland, United States, 20770
        • Pfizer Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Pfizer Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Pfizer Investigational Site
    • New Jersey
      • Marlton, New Jersey, United States, 8053
        • Pfizer Investigational Site
      • Passaic, New Jersey, United States, 07055
        • Pfizer Investigational Site
      • Teaneck, New Jersey, United States, 07666
        • Pfizer Investigational Site
    • New York
      • Brooklyn, New York, United States, 11203
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10035
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Erie, Pennsylvania, United States, 16508
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15904
        • Pfizer Investigational Site
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19102
        • Pfizer Investigational Site
      • Philadephia, Pennsylvania, United States, 19152
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • El Paso, Texas, United States, 79902
        • Pfizer Investigational Site
      • Fort Worth, Texas, United States, 76107
        • Pfizer Investigational Site
      • Plano, Texas, United States, 75093
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78240
        • Pfizer Investigational Site
      • San Antonio, Texas, United States, 78232
        • Pfizer Investigational Site
    • Virginia
      • Arlington, Virginia, United States, 22204
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98166-2967
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 2
Drug: naproxen
naproxen 500 mg capsule twice daily for 12 weeks
ACTIVE_COMPARATOR: Arm 1
Drug: valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks
PLACEBO_COMPARATOR: Arm 3
Drug: placebo
placebo tablet every morning and capsule every evening for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR-20 criteria responder
Time Frame: Week 12
Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

January 1, 2005

Study Completion (ACTUAL)

January 1, 2005

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

April 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2008

Last Update Submitted That Met QC Criteria

July 18, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3471018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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