Clinical trial NCT01059864: Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Official title: Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: cholesterol
lipids
rheumatoid arthritis
CP-690
550
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol levels and then the effects of adding atorvastatin on those levels.


Eligibility criteria: Inclusion Criteria:

* must be diagnosed as having active rheumatoid arthritis
* agree to participate in the study and sign and informed consent document

Exclusion Criteria:

* History of serious infection within the past 6 months
* test positive for TB
* have any uncontrolled clinically significant disease or laboratory tests
* require administration of prohibited medications during the study

Primary outcomes:
measure: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
timeFrame: Baseline (Week 6), Week 12
Secondary outcomes:
measure: Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
timeFrame: Baseline (Week 6), Week 12
measure: 12-Hours Fasting Lipid Profile
timeFrame: Day 0, Week 2, 6 (Baseline), 10, 12
measure: 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
timeFrame: Day 0, Week 2, 6 (Baseline), 10, 12
measure: 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
timeFrame: Day 0, Week 2, 6 (Baseline), 10, 12
measure: 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
timeFrame: Day 0, Week 2, 6 (Baseline), 10, 12
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 6 (Baseline), 12
measure: Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 6 (Baseline), 12
measure: Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 6 (Baseline), 12
measure: Tender-Joint Count
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Swollen-Joint Count
timeFrame: Day 0, Week 6 (Baseline), Week 12
measure: C-Reactive Protein (CRP)
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Patient Assessment of Arthritis Pain
timeFrame: Day 0, Week 6 (Baseline), 12
measure: Physician's Global Assessment (PhysGA) of Arthritis Pain
timeFrame: Day 0, Week 6 (Baseline), Week 12
measure: Patient's Global Assessment (PtGA) of Arthritis Pain
timeFrame: Day 0, Week 6 (Baseline), Week 12
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Day 0, Week 6 (Baseline), 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Gilbert
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Upland
country: United States
facility: Pfizer Investigational Site
state: California
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Allen
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
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: 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.
citation: McInnes IB, Kim HY, Lee SH, Mandel D, Song YW, Connell CA, Luo Z, Brosnan MJ, Zuckerman A, Zwillich SH, Bradley JD. Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis. 2014 Jan;73(1):124-31. doi: 10.1136/annrheumdis-2012-202442. Epub 2013 Mar 12.