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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00650455
Collaborator
(none)
489
Enrollment
55
Locations
3
Arms
23
Duration (Months)
8.9
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
489 participants
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2003
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm 2

Drug: naproxen
naproxen 500 mg capsule twice daily for 12 weeks
Placebo Comparator: Arm 3

Drug: placebo
placebo tablet every morning and capsule every evening for 12 weeks
Active Comparator: Arm 1

Drug: valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks

Outcome Measures

Primary Outcome Measures

  1. ACR-20 criteria responder [Week 12]

Secondary Outcome Measures

  1. Patient's Global Assessment of Disease Activity [Screening, Baseline, Week 1, Week 6, and Week 12]

  2. Duration of morning stiffness [Screening, Baseline, Week 1, Week 6, and Week 12]

  3. Incidence and time to withdrawal due to insufficient clinical response [Study endpoint]

  4. Physician's Global Assessment of Disease Activity [Screening, Baseline, Week 1, Week 6, and Week 12]

  5. swollen joint count [Screening, Baseline, Week 1, Week 6, and Week 12]

  6. Adverse events [Baseline, Week 1, Week 6, and Week 12]

  7. Average rescue medication usage per day [Study endpoint]

  8. Short Form-36 Acute Health Survey [Baseline, Week 1, Week 6, and Week 12]

  9. tender joint count [Screening, Baseline, Week 1, Week 6, and Week 12]

  10. One-Week Severity of Dyspepsia Assessment [Baseline, Week 1, and Week 12]

  11. C-reactive protein [Screening, Baseline, Week 1, Week 6, and Week 12]

  12. laboratory tests [Screening, Baseline, Week 1, Week 6, and Week 12]

  13. vital signs [Screening, Baseline, Week 1, Week 6, and Week 12]

  14. physical examinations [Screening and Week 12]

  15. ACR-N [Study endpoint]

  16. Patient Treatment Satisfaction Scale [Week 1 and Week 6]

  17. Patient's assessment of arthritis pain (VAS) [Screening, Baseline, Week 1, Week 6, and Week 12]

  18. Health Assessment Questionnaire (HAQ) Disability Index [Screening, Baseline, Week 1, Week 6, and Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Birmingham Alabama United States 35249-7201
2 Pfizer Investigational Site Huntsville Alabama United States 35801
3 Pfizer Investigational Site Glendale Arizona United States 85304
4 Pfizer Investigational Site Glendale Arizona United States 85308
5 Pfizer Investigational Site Mesa Arizona United States 85202
6 Pfizer Investigational Site Paradise Valley Arizona United States 85253
7 Pfizer Investigational Site Phoenix Arizona United States 85012
8 Pfizer Investigational Site Scottsdale Arizona United States 95260
9 Pfizer Investigational Site Tucson Arizona United States 85719
10 Pfizer Investigational Site Fullerton California United States 92835
11 Pfizer Investigational Site Rancho Mirage California United States 92270
12 Pfizer Investigational Site San Diego California United States 92120
13 Pfizer Investigational Site Fort Lauderdale Florida United States 33334
14 Pfizer Investigational Site Jacksonville Florida United States 32204
15 Pfizer Investigational Site Jupiter Florida United States 33458
16 Pfizer Investigational Site Ocala Florida United States 34474
17 Pfizer Investigational Site Orlando Florida United States 32804
18 Pfizer Investigational Site Palm Harbor Florida United States 34684
19 Pfizer Investigational Site Tampa Florida United States 33614
20 Pfizer Investigational Site West Palm Beach Florida United States 33401
21 Pfizer Investigational Site Zephyrhills Florida United States 33540
22 Pfizer Investigational Site Idaho Falls Idaho United States 83404
23 Pfizer Investigational Site Chicago Illinois United States 60612
24 Pfizer Investigational Site Springfield Illinois United States 62704
25 Pfizer Investigational Site Indianapolis Indiana United States 46227
26 Pfizer Investigational Site Frederick Maryland United States 21702
27 Pfizer Investigational Site Greenbelt Maryland United States 20770
28 Pfizer Investigational Site Lansing Michigan United States 48910
29 Pfizer Investigational Site Jackson Mississippi United States 39216
30 Pfizer Investigational Site Marlton New Jersey United States 8053
31 Pfizer Investigational Site Passaic New Jersey United States 07055
32 Pfizer Investigational Site Teaneck New Jersey United States 07666
33 Pfizer Investigational Site Brooklyn New York United States 11203
34 Pfizer Investigational Site New York New York United States 10021
35 Pfizer Investigational Site New York New York United States 10035
36 Pfizer Investigational Site Columbus Ohio United States 43214
37 Pfizer Investigational Site Allentown Pennsylvania United States 18103
38 Pfizer Investigational Site Duncansville Pennsylvania United States 16635
39 Pfizer Investigational Site Erie Pennsylvania United States 16508
40 Pfizer Investigational Site Johnstown Pennsylvania United States 15904
41 Pfizer Investigational Site Mechanicsburg Pennsylvania United States 17055
42 Pfizer Investigational Site Philadelphia Pennsylvania United States 19102
43 Pfizer Investigational Site Philadephia Pennsylvania United States 19152
44 Pfizer Investigational Site Providence Rhode Island United States 02906
45 Pfizer Investigational Site Dallas Texas United States 75246
46 Pfizer Investigational Site El Paso Texas United States 79902
47 Pfizer Investigational Site Fort Worth Texas United States 76107
48 Pfizer Investigational Site Plano Texas United States 75093
49 Pfizer Investigational Site San Antonio Texas United States 78232
50 Pfizer Investigational Site San Antonio Texas United States 78240
51 Pfizer Investigational Site Arlington Virginia United States 22204
52 Pfizer Investigational Site Seattle Washington United States 98166-2967
53 Pfizer Investigational Site Winnipeg Manitoba Canada R3A 1M1
54 Pfizer Investigational Site Windsor Ontario Canada N8W 5L7
55 Pfizer Investigational Site Saskatoon Saskatchewan Canada S7K 0H6

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00650455
Other Study ID Numbers:
  • A3471018
First Posted:
Apr 1, 2008
Last Update Posted:
Jul 21, 2008
Last Verified:
Jul 1, 2008
Keywords provided by , ,
valdecoxib, severe rheumatoid arthritis
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Naproxen
Valdecoxib

Study Results

No Results Posted as of Jul 21, 2008