Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

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NCT01059864

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209, 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

- must be diagnosed as having active rheumatoid arthritis

- agree to participate in the study and sign and informed consent document

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


- History of serious infection within the past 6 months


- test positive for TB


- have any uncontrolled clinically significant disease or laboratory tests


- require administration of prohibited medications during the study

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Official Title  ICMJE Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis
Brief Summary All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.
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 Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CP-690,550
    12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
  • Drug: Atorvastatin
    Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
  • Drug: Atorvastatin Placebo
    Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
Study Arms  ICMJE
  • Experimental: Arm 1
    Interventions:
    • Drug: CP-690,550
    • Drug: Atorvastatin
  • Experimental: Arm 2
    Interventions:
    • Drug: CP-690,550
    • Drug: Atorvastatin 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: November 14, 2012)		111
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2010)		100
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • must be diagnosed as having active rheumatoid arthritis
  • agree to participate in the study and sign and informed consent document

Exclusion Criteria:

  • History of serious infection within the past 6 months
  • test positive for TB
  • have any uncontrolled clinically significant disease or laboratory tests
  • require administration of prohibited medications during the study
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 Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01059864
Other Study ID Numbers  ICMJE A3921109
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 November 2012

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