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

• 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 ]

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.

• 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

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