Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT01262118 |
Recruitment Status :
Completed
First Posted : December 17, 2010
Results First Posted : January 23, 2013
Last Update Posted : January 23, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: CP-690,550 (tasocitinib) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
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 |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | February 2012 |

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
|
- High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline [ Time Frame: Baseline ]Blood level of HDL-C was measured following a 12-hours fasting.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262118
United States, Alabama | |
Pfizer Investigational Site | |
Anniston, Alabama, United States, 36201 | |
Pfizer Investigational Site | |
Anniston, Alabama, United States, 36207 | |
United States, Arkansas | |
Pfizer Investigational Site | |
Little Rock, Arkansas, United States, 72201 | |
United States, California | |
Pfizer Investigational Site | |
Los Angeles, California, United States, 90095 | |
United States, Florida | |
Pfizer Investigational Site | |
Daytona Beach, Florida, United States, 32114 | |
Pfizer Investigational Site | |
Ormond Beach, Florida, United States, 32174 | |
Pfizer Investigational Site | |
South Miami, Florida, United States, 33143 | |
United States, Michigan | |
Pfizer Investigational Site | |
Bingham Farms, Michigan, United States, 48025 | |
United States, Texas | |
Pfizer Investigational Site | |
Dallas, Texas, United States, 75231 | |
Hungary | |
Pfizer Investigational Site | |
Balatonfured, Hungary, 8230 | |
Pfizer Investigational Site | |
Budapest, Hungary, 1032 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01262118 |
Other Study ID Numbers: |
A3921130 |
First Posted: | December 17, 2010 Key Record Dates |
Results First Posted: | January 23, 2013 |
Last Update Posted: | January 23, 2013 |
Last Verified: | December 2012 |
Cholesterol metabolism Cholesterol flux Rheumatoid Arthritis |
Tasocitinib CP-690 550 |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases |
Immune System Diseases Tofacitinib Janus Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |