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Trial record 1 of 1 for:    NCT01262118
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Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01262118
Recruitment Status : Completed
First Posted : December 17, 2010
Results First Posted : January 23, 2013
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 15, 2010
First Posted Date  ICMJE December 17, 2010
Results First Submitted Date  ICMJE December 17, 2012
Results First Posted Date  ICMJE January 23, 2013
Last Update Posted Date January 23, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
  • High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline [ Time Frame: Baseline ]
    Blood level of HDL-C was measured following a 12-hours fasting.
  • High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6 [ Time Frame: Week 6 ]
    Blood level of HDL-C was measured following a 12-hours fasting.
  • Cholesterol Ester Production Rate at Baseline [ Time Frame: Baseline ]
    Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
  • Cholesterol Ester Production Rate at Week 6 [ Time Frame: Week 6 ]
    Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
  • High Density Lipoproteins (HDL), Low Density Lipoproteins (LDL) and total cholesterol concentrations [ Time Frame: 6 weeks ]
  • Cholesterol ester production rate (mg/kg/hr) and cholesterol ester fractional catabolic rate (%/hr) [ Time Frame: 6 weeks ]
  • Low Density Lipoprotein Apolipoprotein B (LDL-apoB) production rate (mg/kg/hr) and fractional catabolic rate (%/hr) [ Time Frame: 6 weeks ]
  • High Density Lipoprotein Apolipoprotein A1 (HDL-apoA1) production rate (mg/kg/hr) and fractional catabolic rate (%/hr) [ Time Frame: 6 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2012)
  • Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration [ Time Frame: Baseline, Week 6 ]
    Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.
  • Cholesterol Ester Fractional Catabolic Rate [ Time Frame: Baseline, Week 6 ]
    Cholesterol ester fractional catabolic rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program. Fractional catabolic rate was the percentage of cholesterol ester which was replaced, transferred or lost per unit of time.
  • Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate [ Time Frame: Baseline, Week 6 ]
    LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
  • Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate [ Time Frame: Baseline, Week 6 ]
    Fractional catabolic rate for LDL ApoB were calculated using the 13 carbon (13C) isotopic enrichment of very low density lipoprotein (VLDL) as the limiting value. Isotope 13C in plasma was measured using Gas Chromatography-Combustion-Isotope Ratio Mass Spectrometry (GC-C-IRMS).
  • High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate [ Time Frame: Baseline, Week 6 ]
    HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
  • High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate [ Time Frame: Baseline, Week 6 ]
    Fractional catabolic rate for HDL-apoA1 were calculated using the 13C isotopic enrichment of VLDL as the limiting value. Isotope 13C in plasma was measured using GC-C-IRMS.
  • Cholesterol Efflux Rate [ Time Frame: Baseline, Week 6 ]
    Cholesterol efflux rate was measured using isotope dilution method in which rate of appearance of isotope 13C-free cholesterol in plasma representing whole body efflux from tissues was assessed. Isotope 13C in plasma was measured using GC-C-IRMS.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
  • Incidence and severity of adverse events [ Time Frame: 6 weeks ]
  • Incidence and severity of clinical laboratory abnormalities [ Time Frame: 6 weeks ]
  • Mean change from baseline in vital signs (blood pressure, heart rate, and temperature) measurements [ Time Frame: 6 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
Official Title  ICMJE An Exploratory Phase 1, Fixed Sequence, Open-Label Study To Assess The Effects Of CP-690,550 On The Kinetics Of Cholesterol Flux Through The High Density Lipoprotein/Reverse Cholesterol Transport Pathway In Patients With Active Rheumatoid Arthritis
Brief Summary The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Drug: CP-690,550 (tasocitinib)
CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis
Study Arms  ICMJE
  • Experimental: CP-690,550 (tasocitinib) 10 mg twice daily (BID)
    Intervention: Drug: CP-690,550 (tasocitinib)
  • No Intervention: Healthy Volunteers
    No intervention
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: March 7, 2012)
69
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2010)
60
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, 18 years of age or older with active rheumatoid arthritis; Or male and female healthy volunteers 18 years of age and older

Exclusion Criteria:

  • Pregnant or lactating women
  • Clinically significant systemic disease (other than RA for RA arm)
  • Use of lipid-regulating agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262118
Other Study ID Numbers  ICMJE A3921130
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 Center Pfizer
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