A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

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NCT00847613

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Study Location
Pfizer Investigational Site
Huntsville, Alabama, 35801, 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

- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

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


- Pregnancy, severe acute or chronic medical conditions, including serious infections or
clinically significant laboratory abnormalities.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Official Title  ICMJE Phase 3 Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
Brief Summary This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
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
    Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: CP-690,550
    Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, Active Extension Period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, Active Extension Period
  • Drug: Placebo
    Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, placebo-controlled period
  • Drug: Placebo
    Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
    Other Name: Double-blind, Active Extension Period
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
    Other Name: Double-blind, placebo-controlled period
Study Arms  ICMJE
  • Experimental: Sequence 1
    Interventions:
    • Drug: CP-690,550
    • Drug: CP-690,550
  • Experimental: Sequence 2
    Interventions:
    • Drug: CP-690,550
    • Drug: CP-690,550
  • Placebo Comparator: Sequence 3
    Interventions:
    • Drug: Placebo
    • Drug: CP-690,550
  • Placebo Comparator: Sequence 4
    Interventions:
    • Drug: Placebo
    • 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: January 14, 2013)		800
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)		750
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate

Exclusion Criteria:

  • Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
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 Australia,   Brazil,   Bulgaria,   Canada,   Colombia,   Czech Republic,   Greece,   India,   Japan,   Korea, Republic of,   Mexico,   Poland,   Taiwan,   Ukraine,   United States
Removed Location Countries Venezuela
 
Administrative Information
NCT Number  ICMJE NCT00847613
Other Study ID Numbers  ICMJE A3921044
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 January 2013

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