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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205 United States
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
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 baseline synovial biopsy.

- An absolute white blood cell (WBC) count of neutrophil count of prior to baseline synovial biopsy.

- Thrombocytopenia, as defined by a platelet count screening visit or within the 3 months prior to baseline synovial biopsy.

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

NCT00976599
Pfizer
Completed
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

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A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Rheumatoid Arthritis
  • 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
  • Experimental: CP-690,550 + methotrexate
    Intervention: Drug: CP-690,550 + methotrexate
  • Placebo Comparator: Placebo + methotrexate
    Intervention: Drug: Placebo + Methotrexate


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2011
July 2011   (Final data collection date for primary outcome measure)

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 .
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00976599
A3921073
No
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

FOR MORE INFORMATION

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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1-800-718-1021

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