A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

This study has been terminated.
(See Detailed Description field)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00424294
First received: January 18, 2007
Last updated: March 24, 2011
Last verified: March 2011

January 18, 2007
March 24, 2011
June 2006
December 2007   (final data collection date for primary outcome measure)
ACR 20 response rate after 12 weeks of treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
ACR 20 response rate after 12 weeks of treatment
Complete list of historical versions of study NCT00424294 on ClinicalTrials.gov Archive Site
  • ACR 20 response rate at Weeks 1, 2, 4 and 8 [ Time Frame: Weeks 1,2,4,8 ] [ Designated as safety issue: No ]
  • The following at Weeks 1, 2, 4, 8 and 12: [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • ACR 50/70 response rate [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Tender/painful Joint count (28) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Swollen joint count (28) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Physician's Global Assessment of Arthritic Condition [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Patient's Assessment of Arthritic Pain (VAS) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Disease Activity Score (DAS28-3 (CRP)) [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Duration of Morning Stiffness [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritic Condition [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: Weeks 1,2,4,8 and 12 ] [ Designated as safety issue: No ]
  • Overall incidence and time to withdrawal due to lack of efficacy will be analyzed. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Safety and tolerability Evaluate health and functional status
Not Provided
Not Provided
 
A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: CP-195,543
    CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.
  • Drug: celecoxib
    Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
  • Drug: Methotrexate
    Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
  • Active Comparator: Celecoxib
    Celecoxib with placebo therapy.
    Intervention: Drug: celecoxib
  • Methotrexate
    Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
    Intervention: Drug: Methotrexate
  • Experimental: CP-195,543
    CP-195,543 and Celecoxib dual therapy.
    Intervention: Drug: CP-195,543
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
70
February 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
  • Active disease at Screening
  • Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

  • A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
  • A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00424294
A7701005
Yes
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP