Comparison Of 3 Dose Levels Of CP-690,550 VS. Placebo For Treatment Of Rheumatoid Arthritis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00147498

Purpose

The immune system normally fights infection, but in diseases like RA, the immune system may be overactive or act incorrectly, leading to inflammation, seen as such things as swelling and pain. Pfizer is developing CP-690,550 as a disease-modifying antirheumatic drug (DMARD-pronounced DEE-mard) for the treatment of RA. The purpose of this type of treatment is to control disease activity, improve symptoms (like swelling and pain), maintain normal, every-day functions and activities, improve physical, emotional, and mental well-being, and slow down joint damage.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: CP-690,550	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis (RA)

Further study details as provided by Pfizer:

Primary Outcome Measures:

The American College of Rheumatology 20 (ACR 20) Responder rate at Week 6

Secondary Outcome Measures:

The American College of Rheumatology 20, 50 and 70 (ACR 20, 50 and 70) Responder rates at Weeks 1, 2, 4, 6 (except for the ACR 20) and 8

Estimated Enrollment:	312
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects With Active RA Who Have Failed Therapy With Either Methotrexate Or A TNF Inhibitor

Exclusion Criteria:

Current Therapy With Any DMARD Or Biologic

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147498

Show 57 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A3921019
Study First Received:	September 2, 2005
Last Updated:	November 10, 2006
ClinicalTrials.gov Identifier:	NCT00147498
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases

Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009