Long-Term, Open-Label Study Of CP-690,550 For Treatment Of Rheumatoid Arthritis In Japan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00661661
First received: February 7, 2008
Last updated: February 19, 2014
Last verified: February 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The long-term safety and tolerability of CP-690,550 5 mg and 10 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, 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 ]

Enrollment: 487
Study Start Date: April 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-690,550 Drug: CP-690,550
5 mg BID up to 10 mg BID until launch

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661661

Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Narashino, Chiba, Japan
Pfizer Investigational Site
Yotukaidou, Chiba, Japan
Pfizer Investigational Site
Iiduka, Fukuoka, Japan
Pfizer Investigational Site
Kitakyusyu, Fukuoka, Japan
Pfizer Investigational Site
Kurume, Fukuoka, Japan
Pfizer Investigational Site
Sawara-ku, Fukuoka, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Higashihiroshima, Hiroshima, Japan
Pfizer Investigational Site
Hiroshima-city, Hiroshima, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Nishinomiya, Hyogo, Japan
Pfizer Investigational Site
Hitachi-shi, Ibaraki, Japan
Pfizer Investigational Site
Tsukuba, Ibaraki, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Koushi, Kumamoto, Japan
Pfizer Investigational Site
Tsu, Mie, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Ohmura, Nagasaki, Japan
Pfizer Investigational Site
Sasebo, Nagasaki, Japan
Pfizer Investigational Site
Kashihara, Nara, Japan
Pfizer Investigational Site
Kawachinagano, Osaka, Japan
Pfizer Investigational Site
Ureshino, Saga, Japan
Pfizer Investigational Site
Kawagoe-shi, Saitama, Japan
Pfizer Investigational Site
Kitamoto, Saitama, Japan
Pfizer Investigational Site
Hamamatsu, Shizuoka, Japan
Pfizer Investigational Site
Arakawa-ku, Tokyo, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Koto-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Musashimurayama-shi, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjyuku-ku, Tokyo, Japan
Pfizer Investigational Site
Chiba, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Fukusima, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Kumamoto, Japan
Pfizer Investigational Site
Kyoto, Japan
Pfizer Investigational Site
Miyagi, Japan
Pfizer Investigational Site
Nagasaki, Japan
Pfizer Investigational Site
Niigata, Japan
Pfizer Investigational Site
Oita, Japan
Pfizer Investigational Site
Osaka, Japan
Pfizer Investigational Site
Saitama, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00661661     History of Changes
Other Study ID Numbers: A3921041
Study First Received: February 7, 2008
Last Updated: February 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Pfizer:
Long term open label study in Japan
CP-690,550
tofacitinib

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014