A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

NCT00976599

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject must have a diagnosis of rheumatoid arthritis based on the American College of Rheumatology Association

- The subject has active disease at both Screening and Baseline, as defined:

- ≥4 joints tender or painful on motion, AND

- ≥4 joints swollen;

- The subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique

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


- No arthroscopy should have been performed in the past 3 months in the same joint that
is to be biopsied in this study.


- No intra-articular steroids should have been injected in the joint to be biopsied in
this study in the previous 3 months.


- Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels <
9.0 gm/dL or hematocrit < 30 % at screening visit or within the 3 months prior to
baseline synovial biopsy.


- An absolute white blood cell (WBC) count of < 3.0 x 109/L (<3000/mm3) or absolute
neutrophil count of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3 months
prior to baseline synovial biopsy.


- Thrombocytopenia, as defined by a platelet count <100 x 109/L (< 100,000/mm3) at
screening visit or within the 3 months prior to baseline synovial biopsy.


- Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
Official Title  ICMJE An Exploratory Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Assess The Pharmacodynamics Of CP-690,550, Administered Orally Twice Daily (BID) For 4 Weeks, In Subjects With Active Rheumatoid Arthritis
Brief Summary To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.
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: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CP-690,550 + methotrexate
    CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ? 7.5 mg / week and ? 25 mg / week
  • Drug: Placebo + Methotrexate
    Methotrexate dose is ? 7.5 mg / week and ? 25 mg / week
Study Arms  ICMJE
  • Experimental: CP-690,550 + methotrexate
    Intervention: Drug: CP-690,550 + methotrexate
  • Placebo Comparator: Placebo + methotrexate
    Intervention: Drug: Placebo + Methotrexate
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: November 5, 2012)
29
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2009)
30
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must have a diagnosis of rheumatoid arthritis based on the American College of Rheumatology Association
  • The subject has active disease at both Screening and Baseline, as defined:

    • ?4 joints tender or painful on motion, AND
    • ?4 joints swollen;
  • The subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique

Exclusion Criteria:

  • No arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
  • No intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
  • Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels < 9.0 gm/dL or hematocrit < 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
  • An absolute white blood cell (WBC) count of < 3.0 x 109/L (<3000/mm3) or absolute neutrophil count of <1.2 X 109/L (<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
  • Thrombocytopenia, as defined by a platelet count <100 x 109/L (< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
  • Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00976599
Other Study ID Numbers  ICMJE A3921073
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 December 2012

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