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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01262118
First received: November 15, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: CP-690,550 (tasocitinib)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Blood level of HDL-C was measured following a 12-hours fasting.

  • Cholesterol Ester Production Rate at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.


Secondary Outcome Measures:
  • Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262118

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01262118     History of Changes
Other Study ID Numbers: A3921130
Study First Received: November 15, 2010
Results First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Cholesterol metabolism
Cholesterol flux
Rheumatoid Arthritis
Tasocitinib
CP-690
550

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014