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Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan
This study is currently recruiting participants.
Verified by Pfizer, January 2009
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00661661
  Purpose

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are only eligible for this study after they have completed participation in another "qualifying" study of CP-690,550.


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

MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Long-Term, Open-Label Study Of CP-690,550 To Confirm The Safety Following Long Term Administration Of CP-690,550 In The Treatment Of Rheumatoid Arthritis

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The long-term safety and tolerability of CP-690,550 5 mg BID for the treatment of rheumatoid arthritis [ Time Frame: at multiple timepoints ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR 20, 50 and 70 response rates at 3, 6, 9 and 12 months; DAS and quality of life assessments at multiple timepoints throughout the course of the study [ Time Frame: at multiple timepoints ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CP-690,550, 1 mg: Experimental Drug: CP-690,550
5 mg BID, 5 tablets administered BID for 2 years.

  Eligibility

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

Inclusion Criteria:

  • Subjects who have completed their participation in a randomized "qualifying" study of CP-690,550 for the treatment of rheumatoid arthritis

Exclusion Criteria:

  • Serious medical conditions that would make treatment with CP-690,550 potentially unsafe
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661661

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Japan
Pfizer Investigational Site Recruiting
Chiba, Japan
Pfizer Investigational Site Recruiting
Fukuoka, Japan
Pfizer Investigational Site Recruiting
Niigata, Japan
Japan, Fukuoka
Pfizer Investigational Site Recruiting
Kitakyusyu, Fukuoka, Japan
Japan, Ibaraki
Pfizer Investigational Site Recruiting
Hitachi-shi, Ibaraki, Japan
Japan, Kanagawa
Pfizer Investigational Site Recruiting
Sagamihara, Kanagawa, Japan
Japan, Kumamoto
Pfizer Investigational Site Recruiting
Koushi, Kumamoto, Japan
Japan, Miyagi
Pfizer Investigational Site Recruiting
Sendai, Miyagi, Japan
Japan, Osaka
Pfizer Investigational Site Recruiting
Kawachinagano, Osaka, Japan
Japan, Saitama
Pfizer Investigational Site Recruiting
Kawagoe-shi, Saitama, Japan
Pfizer Investigational Site Recruiting
Kitamoto, Saitama, Japan
Japan, Tokyo
Pfizer Investigational Site Recruiting
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Koto-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site Recruiting
Musashimurayama-shi, 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: A3921041
Study First Received: February 7, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00661661  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:
Long term open label study 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 15, 2009