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Completed

NCT Number: NCT01262118

Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism 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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Balatonfüred, Hungary

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-690,550 (tasocitinib)

Drug

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

Primary outcomes

  1. High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline

    Time frame: Baseline

    Blood level of HDL-C was measured following a 12-hours fasting.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 17, 2010
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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