Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis

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NCT00413660

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Study Location
Pfizer Investigational Site
Gilbert, Arizona, 85234, United States
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Contact
1-800-718-1021
[email protected]
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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
18 + 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 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis
Official Title  ICMJE A Phase 2B, Randomized, Double Blind, Placebo-Controlled, Multicenter Study To Compare 6 Dose Regimens Of CP-690,550 Vs. Placebo, Each Combined With Methotrexate, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate Alone
Brief Summary The purpose of this study is to determine the effectiveness and safety, over 6 months, of 6 dose regimens of CP-690,550, combined with methotrexate, for the treatment of adults 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: CP-690,550
    4 blinded tablets administered BID
  • Drug: CP-690,550
    Oral tablets
  • Other: placebo
    Placebo
Study Arms  ICMJE
  • Experimental: CP 690,550 1 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP 690,550 10 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP 690,550 15 mg
    Intervention: Drug: CP-690,550
  • Experimental: CP 690,550 3 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP 690,550 5 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP-690,550 20 mg QD
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo
    Dummy tablets
    Intervention: Other: placebo
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: January 14, 2013)		509
Original Enrollment  ICMJE
 (submitted: December 18, 2006)		483
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 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 18 Years and older   (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 Argentina,   Brazil,   Bulgaria,   Chile,   Czech Republic,   Hungary,   Mexico,   Poland,   Slovakia,   Spain,   Sweden,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00413660
Other Study ID Numbers  ICMJE A3921025
Has Data Monitoring Committee No
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 January 2013

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