Conditions: Arthritis, Rheumatoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 70
Healthy volunteers: no

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

Detailed description:
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.

Arms:
arm 1: Celecoxib with placebo therapy. arm 2: Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms. arm 3: CP-195,543 and Celecoxib dual therapy.

Interventions: intervention 1: CP-195,543 intervention 2: celecoxib intervention 3: Methotrexate
Intervention descriptions: intervention 1: CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor. intervention 2: 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. intervention 3: 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.

Protocol document: