Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00687193

Purpose

To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for the treatment of signs and symptoms in patients with active RA who failed an adequate trial of therapy with at least 1 DMARD in a 12-week therapy.

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 (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Confirm Dose Responsiveness Following 12 Weeks Of The Administration Of CP-690,550 (5 Doses) Or Placebo In Subjects With Active Rheumatoid Arthritis Inadequately Responding To At Least 1 DMARD

Further study details as provided by Pfizer:

Primary Outcome Measures:

ACR 20 responder rate at Week 12 [ Time Frame: At week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

DAS28-3 (CRP), DAS28-4 (ESR) [ Time Frame: At multiple time ] [ Designated as safety issue: No ]
ACR 20, 50, 70, and 90 Responder rates , area under the ACR-N curve at all timepoints. Observed values and changes from baseline of the 7 components of the ACR Core set. [ Time Frame: At multiple time ] [ Designated as safety issue: No ]
QOL assessments (SF-36, HAQ-DI, EQ-5D) [ Time Frame: At multiple time ] [ Designated as safety issue: No ]
Incidence and severity of AEs and lab test abnormalities, vital signs, ECG [ Time Frame: At multiple time ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP-690,550, 0mg: Experimental	Drug: CP-690,550 0mg BID, 3 blinded tablets administered BID for 12 weeks
CP-690,550, 10mg: Experimental	Drug: CP-690,550 10mg BID, 3 blinded tablets administered BID for 12 weeks
CP-690,550, 15mg: Experimental	Drug: CP-690,550 15mg BID, 3 blinded tablets administered BID for 12 weeks
CP-690,550, 1mg: Experimental	Drug: CP-690,550 1mg BID, 3 blinded tablets administered BID for 12 weeks
CP-690,550, 3mg: Experimental	Drug: CP-690,550 3mg BID, 3 blinded tablets administered BID for 12 weeks
CP-690,550, 5mg: Experimental	Drug: CP-690,550 5mg BID, 3 blinded tablets administered BID for 12 weeks

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to lack of efficacy or toxicity.

Exclusion Criteria:

Current therapy with any DMARD

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687193

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921040
Study First Received:	May 22, 2008
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00687193
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:

Phase II mono therapy in Japan

Study placed in the following topic categories:

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