Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550

• 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
• Phase: Phase 2

Countries of recruitment

Korea, Republic of, United States

Contacts

• Name: Pfizer CT.gov Call Center
• 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: CP-690,550

Drug: Atorvastatin

Drug: Atorvastatin Placebo

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]

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]

Physician's Global Assessment (PhysGA) of Arthritis Pain [Time Frame: Day 0, Week 6 (Baseline), Week 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: 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]

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]

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]

Erythrocyte Sedimentation Rate (ESR) [Time Frame: Day 0, Week 6 (Baseline), 12]

Tender-Joint Count [Time Frame: Day 0, Week 6 (Baseline), 12]

Secondary ID(s)

A3921109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/12/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01059864