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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hitachi-shi, Ibaraki, Japan
Contact
1-800-718-1021
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

NCT00603512
Pfizer
Completed
Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

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Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • 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
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
September 2008
September 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active rheumatoid arthritis
  • Inadequate response to stably dosed methotrexate

Exclusion Criteria:

  • Current therapy with any DMARD or biologic other than methotrexate
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00603512
A3921039
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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