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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: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT01059864
Date of registration: 28/01/2010
Prospective Registration: Yes
Primary sponsor: Pfizer
Public title: Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Scientific 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
Date of first enrolment: February 2010
Target sample size: 111
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01059864
Study type:  Interventional
Study design:   
Phase:  Phase 2
Countries of recruitment
Korea, Republic of United States
Contacts
Name:     Pfizer CT.gov Call Center
Address: 
Telephone:
Email:
Affiliation:  Pfizer
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Atorvastatin
Drug: Atorvastatin Placebo
Drug: CP-690,550
Primary Outcome(s)
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 [Time Frame: Baseline (Week 6), Week 12]
Secondary Outcome(s)
C-Reactive Protein (CRP) [Time Frame: Day 0, Week 6 (Baseline), 12]
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) [Time Frame: Day 0, Week 6 (Baseline), 12]
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) [Time Frame: Day 0, Week 6 (Baseline), 12]
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Time Frame: Day 0, Week 6 (Baseline), 12]
Erythrocyte Sedimentation Rate (ESR) [Time Frame: Day 0, Week 6 (Baseline), 12]
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [Time Frame: Baseline (Week 6), Week 12]
12-Hours Fasting Lipid Profile [Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles [Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins [Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) [Time Frame: Day 0, Week 6 (Baseline), 12]
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response [Time Frame: Week 6 (Baseline), 12]
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response [Time Frame: Week 6 (Baseline), 12]
Tender-Joint Count [Time Frame: Day 0, Week 6 (Baseline), 12]
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles [Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12]
Patient's Global Assessment (PtGA) of Arthritis Pain [Time Frame: Day 0, Week 6 (Baseline), Week 12]
Physician's Global Assessment (PhysGA) of Arthritis Pain [Time Frame: Day 0, Week 6 (Baseline), Week 12]
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response [Time Frame: Week 6 (Baseline), 12]
Swollen-Joint Count [Time Frame: Day 0, Week 6 (Baseline), Week 12]
Health Assessment Questionnaire Disability Index (HAQ-DI) [Time Frame: Day 0, Week 6 (Baseline), 12]
Patient Assessment of Arthritis Pain [Time Frame: Day 0, Week 6 (Baseline), 12]
Secondary ID(s)
A3921109
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 13/12/2012
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01059864
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