Clinical trial NCT01262118: Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: Cholesterol metabolism
Cholesterol flux
Rheumatoid Arthritis
Tasocitinib
CP-690
550
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: High-density Lipoprotein Cholesterol (HDL-C) Concentration at Baseline
timeFrame: Baseline
measure: High-density Lipoprotein Cholesterol (HDL-C) Concentration at Week 6
timeFrame: Week 6
measure: Cholesterol Ester Production Rate at Baseline
timeFrame: Baseline
measure: Cholesterol Ester Production Rate at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Low-density Lipoprotein Cholesterol (LDL-C) and Total Cholesterol Concentration
timeFrame: Baseline, Week 6
measure: Cholesterol Ester Fractional Catabolic Rate
timeFrame: Baseline, Week 6
measure: Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Production Rate
timeFrame: Baseline, Week 6
measure: Low-density Lipoprotein Associated With Apolipoprotein B (LDL-apoB) Fractional Catabolic Rate
timeFrame: Baseline, Week 6
measure: High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Production Rate
timeFrame: Baseline, Week 6
measure: High-density Lipoprotein Associated With Apolipoprotein A1 (HDL-apoA1) Fractional Catabolic Rate
timeFrame: Baseline, Week 6
measure: Cholesterol Efflux Rate
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Anniston
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Bingham Farms
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Balatonfured
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
citation: Charles-Schoeman C, Fleischmann R, Davignon J, Schwartz H, Turner SM, Beysen C, Milad M, Hellerstein MK, Luo Z, Kaplan IV, Riese R, Zuckerman A, McInnes IB. Potential mechanisms leading to the abnormal lipid profile in patients with rheumatoid arthritis versus healthy volunteers and reversal by tofacitinib. Arthritis Rheumatol. 2015 Mar;67(3):616-25. doi: 10.1002/art.38974.
citation: Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.