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

NCT ID: NCT00424294

Last Updated: 2014-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Celecoxib

Celecoxib with placebo therapy.

Group Type ACTIVE_COMPARATOR

celecoxib

Intervention Type DRUG

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.

Methotrexate

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

Group Type OTHER

Methotrexate

Intervention Type DRUG

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.

CP-195,543

CP-195,543 and Celecoxib dual therapy.

Group Type EXPERIMENTAL

CP-195,543

Intervention Type DRUG

CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Interventions

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CP-195,543

CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Huntsville, Alabama, United States

Site Status

Pfizer Investigational Site

Scottsdale, Arizona, United States

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Upland, California, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Dunedin, Florida, United States

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Fort Lauderdale, Florida, United States

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Lake Mary, Florida, United States

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Miramar, Florida, United States

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New Port Richey, Florida, United States

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Orange City, Florida, United States

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Orlando, Florida, United States

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Port Richey, Florida, United States

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Sarasota, Florida, United States

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Sarasota, Florida, United States

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Tampa, Florida, United States

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Venice, Florida, United States

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Vero Beach, Florida, United States

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Moline, Illinois, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Munster, Indiana, United States

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Lexington, Kentucky, United States

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Covington, Louisiana, United States

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New Orleans, Louisiana, United States

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Frederick, Maryland, United States

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Kalamazoo, Michigan, United States

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Tupelo, Mississippi, United States

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Springfield, Missouri, United States

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Olean, New York, United States

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Rochester, New York, United States

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Oklahoma City, Oklahoma, United States

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Philladelphia, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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Killeen, Texas, United States

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San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Ogden, Utah, United States

Site Status

Countries

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United States

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7701005&StudyName=A%20Study%20Of%20CP-195543%20And%20Celecoxib%20Dual%20Therapy%20In%20Subjects%20With%20Rheumatoid%20Arthritis

To obtain contact information for a study center near you, click here.

Other Identifiers

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A7701005

Identifier Type: -

Identifier Source: org_study_id

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