Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00413660

Purpose

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults with active rheumatoid arthritis.

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

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

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 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone

Further study details as provided by Pfizer:

Primary Outcome Measures:

American College of Rheumatology 20 (ACR20) [ Time Frame: response rates at week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR 20, 50 and 70 response rates multiple timepoints [ Time Frame: multiple timepoints ] [ Designated as safety issue: No ]
DAS 28-3(CRP) [ Time Frame: multiple timepoints ] [ Designated as safety issue: No ]
quality of life assessments [ Time Frame: multiple timepoints ] [ Designated as safety issue: No ]
sleep assessments [ Time Frame: multiple timepoints ] [ Designated as safety issue: No ]
fatigue assessments [ Time Frame: multiple timepoints ] [ Designated as safety issue: No ]
Incidence and severity of adverse events [ Time Frame: multiple timepoints ] [ Designated as safety issue: Yes ]
clinical laboratory abnormalities [ Time Frame: multiple timepoints ] [ Designated as safety issue: Yes ]
vital signs (blood pressure, heart rate, and oral or tympanic temperature) [ Time Frame: multiple timepoints ] [ Designated as safety issue: Yes ]

Enrollment:	510
Study Start Date:	January 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CP 690,550 1 mg BID: Experimental	Drug: CP-690,550 4 blinded tablets administered BID
CP 690,550 10 mg BID: Experimental	Drug: CP-690,550 4 blinded tablets administered BID
CP 690,550 15 mg: Experimental	Drug: CP-690,550 4 blinded tablets administered BID
CP 690,550 3 mg BID: Experimental	Drug: CP-690,550 4 blinded tablets administered BID
CP 690,550 5 mg BID: Experimental	Drug: CP-690,550 4 blinded tablets administered BID
CP-690,550 20 mg QD: Experimental	Drug: CP-690,550 Oral tablets
Placebo: Placebo Comparator Dummy tablets	Other: placebo Placebo

Eligibility

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

Criteria

Inclusion Criteria:

Active rheumatoid arthritis
Inadequate response to stably dosed methotrexate

Exclusion Criteria:

Current therapy with any DMARD or biologic other than methotrexate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413660

Show 82 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

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A3921025
Study First Received:	December 18, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00413660
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

DMARD therapy

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009