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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
489

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
ACR-20 criteria responder
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2005

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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