Arthritis, RheumatoidPhase 4NCT00650455
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
A Phase 4 study testing valdecoxib and naproxen in people with Arthritis, Rheumatoid, run by Pfizer at 55 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- valdecoxib and naproxen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 489 participants
- Where
- 55 sitesin 2 countries
- Study dates
- Feb 2003to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
55 sites in 2 countries.
55 sites in 2 countries
United States52 sites
Pfizer Investigational Site
Allentown, Pennsylvania, 18103
Pfizer Investigational Site
Arlington, Virginia, 22204
Pfizer Investigational Site
Birmingham, Alabama, 35249-7201
Pfizer Investigational Site
Brooklyn, New York, 11203
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Duncansville, Pennsylvania, 16635
Pfizer Investigational Site
El Paso, Texas, 79902
Pfizer Investigational Site
Erie, Pennsylvania, 16508
Pfizer Investigational Site
Fort Lauderdale, Florida, 33334
Pfizer Investigational Site
Fort Worth, Texas, 76107
Pfizer Investigational Site
Frederick, Maryland, 21702
Pfizer Investigational Site
Fullerton, California, 92835
Pfizer Investigational Site
Glendale, Arizona, 85304
Pfizer Investigational Site
Glendale, Arizona, 85308
Pfizer Investigational Site
Greenbelt, Maryland, 20770
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Idaho Falls, Idaho, 83404
Pfizer Investigational Site
Indianapolis, Indiana, 46227
Pfizer Investigational Site
Jackson, Mississippi, 39216
Pfizer Investigational Site
Jacksonville, Florida, 32204
Pfizer Investigational Site
Johnstown, Pennsylvania, 15904
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
Lansing, Michigan, 48910
Pfizer Investigational Site
Marlton, New Jersey, 8053
Pfizer Investigational Site
Mechanicsburg, Pennsylvania, 17055
Pfizer Investigational Site
Mesa, Arizona, 85202
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10035
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Orlando, Florida, 32804
Pfizer Investigational Site
Palm Harbor, Florida, 34684
Pfizer Investigational Site
Paradise Valley, Arizona, 85253
Pfizer Investigational Site
Passaic, New Jersey, 07055
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19102
Pfizer Investigational Site
Philadephia, Pennsylvania, 19152
Pfizer Investigational Site
Phoenix, Arizona, 85012
Pfizer Investigational Site
Plano, Texas, 75093
Pfizer Investigational Site
Providence, Rhode Island, 02906
Pfizer Investigational Site
Rancho Mirage, California, 92270
Pfizer Investigational Site
San Antonio, Texas, 78232
Pfizer Investigational Site
San Antonio, Texas, 78240
Pfizer Investigational Site
San Diego, California, 92120
Pfizer Investigational Site
Scottsdale, Arizona, 95260
Pfizer Investigational Site
Seattle, Washington, 98166-2967
Pfizer Investigational Site
Springfield, Illinois, 62704
Pfizer Investigational Site
Tampa, Florida, 33614
Pfizer Investigational Site
Teaneck, New Jersey, 07666
Pfizer Investigational Site
Tucson, Arizona, 85719
Pfizer Investigational Site
West Palm Beach, Florida, 33401
Pfizer Investigational Site
Zephyrhills, Florida, 33540
Canada3 sites
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7K 0H6
Pfizer Investigational Site
Windsor, Ontario, N8W 5L7
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1M1
About this study
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
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- valdecoxib, naproxen, placebo
- Keywords
- valdecoxib, severe rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valdecoxibDrug
valdecoxib 10 mg tablet once daily for 12 weeks
naproxenDrug
naproxen 500 mg capsule twice daily for 12 weeks
placeboDrug
placebo tablet every morning and capsule every evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Active comparator | Not described Receives: Drug: naproxen |
| Arm 3 | Placebo comparator | Not described Receives: Drug: placebo |
| Arm 1 | Active comparator | Not described Receives: Drug: valdecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR-20 criteria responder
Measured: Week 12
Secondary outcomes (18)
Patient's Global Assessment of Disease Activity
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
Duration of morning stiffness
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
Incidence and time to withdrawal due to insufficient clinical response
Measured: Study endpoint
Physician's Global Assessment of Disease Activity
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
swollen joint count
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
Adverse events
Measured: Baseline, Week 1, Week 6, and Week 12
Average rescue medication usage per day
Measured: Study endpoint
Short Form-36 Acute Health Survey
Measured: Baseline, Week 1, Week 6, and Week 12
tender joint count
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
One-Week Severity of Dyspepsia Assessment
Measured: Baseline, Week 1, and Week 12
C-reactive protein
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
laboratory tests
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
vital signs
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
physical examinations
Measured: Screening and Week 12
ACR-N
Measured: Study endpoint
Patient Treatment Satisfaction Scale
Measured: Week 1 and Week 6
Patient's assessment of arthritis pain (VAS)
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
Health Assessment Questionnaire (HAQ) Disability Index
Measured: Screening, Baseline, Week 1, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startFeb 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650455
- Sponsor's protocol ID
- A3471018
- Status last verified
- Jul 2008
- First submitted
- 28 Mar 2008
- Last updated
- 21 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00650455
- Acronym / sponsor ID
- A3471018
- Conditions
- Arthritis, Rheumatoid
- Keywords
- valdecoxib, severe rheumatoid arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Active comparator | Drug: naproxen |
| Arm 3 | Placebo comparator | Drug: placebo |
| Arm 1 | Active comparator | Drug: valdecoxib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| valdecoxibvaldecoxib 10 mg tablet once daily for 12 weeks | Drug | Arm 1 |
| naproxennaproxen 500 mg capsule twice daily for 12 weeks | Drug | Arm 2 |
| placeboplacebo tablet every morning and capsule every evening for 12 weeks | Drug | Arm 3 |
Primary outcome
ACR-20 criteria responder
Time frame: Week 12
18 secondary outcomes
Patient's Global Assessment of Disease Activity
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
Duration of morning stiffness
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
Incidence and time to withdrawal due to insufficient clinical response
Time frame: Study endpoint
Physician's Global Assessment of Disease Activity
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
swollen joint count
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
Adverse events
Time frame: Baseline, Week 1, Week 6, and Week 12
Average rescue medication usage per day
Time frame: Study endpoint
Short Form-36 Acute Health Survey
Time frame: Baseline, Week 1, Week 6, and Week 12
tender joint count
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
One-Week Severity of Dyspepsia Assessment
Time frame: Baseline, Week 1, and Week 12
C-reactive protein
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
laboratory tests
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
vital signs
Time frame: Screening, Baseline, Week 1, Week 6, and Week 12
physical examinations
Time frame: Screening and Week 12
ACR-N
Time frame: Study endpoint
Patient Treatment Satisfaction Scale
Time frame: Week 1 and Week 6
Patient's assessment of arthritis pain (VAS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
55 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valdecoxib and naproxen in people with Arthritis, Rheumatoid, run by Pfizer at 55 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR-20 criteria responder (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2008.