Rheumatoid Arthritis Clinical Trial
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
Verified date | December 2012 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).
Status | Completed |
Enrollment | 69 |
Est. completion date | February 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Hungary | Pfizer Investigational Site | Balatonfured | |
Hungary | Pfizer Investigational Site | Budapest | |
United States | Pfizer Investigational Site | Anniston | Alabama |
United States | Pfizer Investigational Site | Anniston | Alabama |
United States | Pfizer Investigational Site | Bingham Farms | Michigan |
United States | Pfizer Investigational Site | Dallas | Texas |
United States | Pfizer Investigational Site | Daytona Beach | Florida |
United States | Pfizer Investigational Site | Little Rock | Arkansas |
United States | Pfizer Investigational Site | Los Angeles | California |
United States | Pfizer Investigational Site | Ormond Beach | Florida |
United States | Pfizer Investigational Site | South Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline | Blood level of HDL-C was measured following a 12-hours fasting. | Baseline | No |
Primary | High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6 | Blood level of HDL-C was measured following a 12-hours fasting. | Week 6 | No |
Primary | 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. | Baseline | No |
Primary | 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. | Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
Secondary | 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). | Baseline, Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
Secondary | 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. | Baseline, Week 6 | No |
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