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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: CP-195,543; Drug: celecoxib; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00424294

A7701005

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 3 patient groups

Celecoxib

Active Comparator group

Description:

Celecoxib with placebo therapy.

Treatment:

Drug: celecoxib

Methotrexate

Other group

Description:

Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.

Treatment:

Drug: Methotrexate

CP-195,543

Experimental group

Description:

CP-195,543 and Celecoxib dual therapy.

Treatment:

Drug: CP-195,543