Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: CP-690,550 (tasocitinib)
- Registration Number
- NCT01262118
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
- 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
- Pregnant or lactating women
- Clinically significant systemic disease (other than RA for RA arm)
- Use of lipid-regulating agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CP-690,550 (tasocitinib) 10 mg twice daily (BID) CP-690,550 (tasocitinib) -
- Primary Outcome Measures
Name Time Method High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline Baseline Blood level of HDL-C was measured following a 12-hours fasting.
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6 Week 6 Blood level of HDL-C was measured following a 12-hours fasting.
Cholesterol Ester Production Rate at Baseline 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 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
Name Time Method Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration Baseline, Week 6 Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.
Cholesterol Ester Fractional Catabolic Rate 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 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 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 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 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 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.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇭🇺Budapest, Hungary