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Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: CP-690,550 (tasocitinib) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : February 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CP-690,550 (tasocitinib) 10 mg twice daily (BID) Drug: CP-690,550 (tasocitinib)
CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis
No Intervention: Healthy Volunteers
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline [ Time Frame: Baseline ]
    Blood level of HDL-C was measured following a 12-hours fasting.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262118


Locations
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United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36201
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72201
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90095
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Michigan
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Hungary
Pfizer Investigational Site
Balatonfured, Hungary, 8230
Pfizer Investigational Site
Budapest, Hungary, 1032
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262118    
Other Study ID Numbers: A3921130
First Posted: December 17, 2010    Key Record Dates
Results First Posted: January 23, 2013
Last Update Posted: January 23, 2013
Last Verified: December 2012
Keywords provided by Pfizer:
Cholesterol metabolism
Cholesterol flux
Rheumatoid Arthritis
 Tasocitinib
CP-690
550
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Tofacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action