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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262118
• Other study ID #: A3921130
• Status: Completed
• Phase: Phase 1
• First received: November 15, 2010
• Last updated: December 17, 2012
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: December 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• CP-690,550 (tasocitinib)
CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Hungary, 

Outcome

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

External Links

•   To obtain contact information for a study center near you, click here.