Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 October 2017 |
Main ID: |
NCT01059864 |
Date of registration:
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28/01/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
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Scientific title:
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Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis |
Date of first enrolment:
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February 2010 |
Target sample size:
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111 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01059864 |
Study type:
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Interventional |
Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Atorvastatin
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Drug: Atorvastatin Placebo
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Drug: CP-690,550
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Primary Outcome(s)
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Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
[Time Frame: Baseline (Week 6), Week 12]
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Secondary Outcome(s)
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C-Reactive Protein (CRP)
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Erythrocyte Sedimentation Rate (ESR)
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
[Time Frame: Baseline (Week 6), Week 12]
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12-Hours Fasting Lipid Profile
[Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
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12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
[Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
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12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
[Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
[Time Frame: Week 6 (Baseline), 12]
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
[Time Frame: Week 6 (Baseline), 12]
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Tender-Joint Count
[Time Frame: Day 0, Week 6 (Baseline), 12]
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12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
[Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
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Patient's Global Assessment (PtGA) of Arthritis Pain
[Time Frame: Day 0, Week 6 (Baseline), Week 12]
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Physician's Global Assessment (PhysGA) of Arthritis Pain
[Time Frame: Day 0, Week 6 (Baseline), Week 12]
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
[Time Frame: Week 6 (Baseline), 12]
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Swollen-Joint Count
[Time Frame: Day 0, Week 6 (Baseline), Week 12]
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Health Assessment Questionnaire Disability Index (HAQ-DI)
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Patient Assessment of Arthritis Pain
[Time Frame: Day 0, Week 6 (Baseline), 12]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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