Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00603512

Purpose

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Placebo Drug: CP-690,550	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 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

ACR 20, 50, 70, and 90, ACR-N and area under the ACR-N curve, Observation values and changes from baseline of the 7 components of the ACR Core set. [ Time Frame: at multiple timepoints ] [ Designated as safety issue: No ]
DAS28-3 (CRP), DAS28-4 (ESR) [ Time Frame: at multiple timepoints ] [ Designated as safety issue: No ]
Quality of life assessments [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
Incidence and severity of AEs and lab test abnormalities, vital signs, ECG [ Time Frame: at multiple timepoints ] [ Designated as safety issue: Yes ]

Enrollment:	140
Study Start Date:	January 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

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

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: NCT00603512

Locations

Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Niigata, Japan
Japan, Ibaraki
Pfizer Investigational Site
Hitachi-shi, Ibaraki, Japan
Japan, Kanagawa
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Japan, Kitakyusyu
Pfizer Investigational Site
Yahatanishi-ku, Kitakyusyu, Japan
Japan, Kumamoto
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Japan, Miyagi
Pfizer Investigational Site
Sendai, Miyagi, Japan
Japan, Osaka
Pfizer Investigational Site
Kawachinagano, Osaka, Japan
Japan, Saitama
Pfizer Investigational Site
Kawagoe-shi, Saitama, Japan
Pfizer Investigational Site
Kitamoto, Saitama, Japan
Japan, Tokyo
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Musashimurayama-shi, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-k, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan

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:	A3921039
Study First Received:	January 17, 2008
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00603512
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Phase II MTX add-on study in Japan

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