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

NCT00603512

Last updated date
Study Location
Pfizer Investigational Site
Hitachi-shi, Ibaraki, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Active rheumatoid arthritis

- Inadequate response to stably dosed methotrexate

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current therapy with any DMARD or biologic other than methotrexate

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Advanced Information
Descriptive Information
Brief Title  ICMJE Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Placebo
    0 mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    10 mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    1 mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    3 mg BID, 3 blinded tablets administered BID for 12 weeks
  • Drug: CP-690,550
    5 mg BID, 3 blinded tablets administered BID for 12 weeks
Study Arms  ICMJE
  • Placebo Comparator: CP-690,550, 0mg
    Intervention: Drug: Placebo
  • Experimental: CP-690,550, 10mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 1mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 3mg
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550, 5mg
    Intervention: Drug: CP-690,550
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 29, 2008)
140
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2008)
125
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Inadequate response to stably dosed methotrexate

Exclusion Criteria:

  • Current therapy with any DMARD or biologic other than methotrexate
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00603512
Other Study ID Numbers  ICMJE A3921039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP