The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
69
CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Anniston, Alabama, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline
Blood level of HDL-C was measured following a 12-hours fasting.
Time frame: Baseline
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6
Blood level of HDL-C was measured following a 12-hours fasting.
Time frame: Week 6
Cholesterol Ester Production Rate at Baseline
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Time frame: Baseline
Cholesterol Ester Production Rate at Week 6
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Time frame: Week 6
Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration
Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.
Time frame: Baseline, Week 6
Cholesterol Ester Fractional Catabolic Rate
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.
Time frame: Baseline, Week 6
Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate
LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
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Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Daytona Beach, Florida, United States
Pfizer Investigational Site
Ormond Beach, Florida, United States
Pfizer Investigational Site
South Miami, Florida, United States
Pfizer Investigational Site
Bingham Farms, Michigan, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Balatonfüred, Hungary
...and 1 more locations
Time frame: Baseline, Week 6
Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate
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).
Time frame: Baseline, Week 6
High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate
HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Time frame: Baseline, Week 6
High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate
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.
Time frame: Baseline, Week 6
Cholesterol Efflux Rate
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.
Time frame: Baseline, Week 6