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

December 17, 2012 updated by: Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Balatonfured, Hungary, 8230
        • Pfizer Investigational Site
      • Budapest, Hungary, 1032
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pfizer Investigational Site
      • Anniston, Alabama, United States, 36201
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • Pfizer Investigational Site
    • California
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
    • Florida
      • Daytona Beach, Florida, United States, 32114
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Michigan
      • Bingham Farms, Michigan, United States, 48025
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75231
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline
Time Frame: Baseline
Blood level of HDL-C was measured following a 12-hours fasting.
Baseline
High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6
Time Frame: Week 6
Blood level of HDL-C was measured following a 12-hours fasting.
Week 6
Cholesterol Ester Production Rate at Baseline
Time Frame: Baseline
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Baseline
Cholesterol Ester Production Rate at Week 6
Time Frame: Week 6
Cholesterol ester production rate was calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration
Time Frame: Baseline, Week 6
Blood level of LDL-C and total cholesterol (TC) was measured following a 12-hours fasting.
Baseline, Week 6
Cholesterol Ester Fractional Catabolic Rate
Time Frame: 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.
Baseline, Week 6
Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate
Time Frame: Baseline, Week 6
LDL-apoB production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Baseline, Week 6
Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate
Time Frame: 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).
Baseline, Week 6
High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate
Time Frame: Baseline, Week 6
HDL-apoA1 production rate were calculated using a 3-pool model with a simulation, analysis and modeling (SAAM II) program.
Baseline, Week 6
High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate
Time Frame: 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.
Baseline, Week 6
Cholesterol Efflux Rate
Time Frame: 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.
Baseline, Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (ESTIMATE)

December 17, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 23, 2013

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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