Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT01059864
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
- must be diagnosed as having active rheumatoid arthritis
- agree to participate in the study and sign and informed consent document
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 CP-690,550 - Arm 2 CP-690,550 - Arm 2 Atorvastatin Placebo - Arm 1 Atorvastatin -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 Baseline (Week 6), Week 12
- Secondary Outcome Measures
Name Time Method Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 Baseline (Week 6), Week 12 12-Hours Fasting Lipid Profile Day 0, Week 2, 6 (Baseline), 10, 12 Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: LDL-C, high-density lipoprotein-cholesterol (HDL-C), very low density lipoprotein-cholesterol (VLDL-C), total cholesterol, apolipoprotein A-1, apolipoprotein B, triglycerides (TGs) and Non-HDL-C.
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins Day 0, Week 2, 6 (Baseline), 10, 12 Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: plasma lipoprotein VLDL-C, LDL-C and HDL-C particles size.
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles Day 0, Week 2, 6 (Baseline), 10, 12 Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total and large VLDL-C and chylomicron particles (VLDLCP), medium and small VLDL-C particles; total, large, medium and small LDL-C particles; and intermediate density lipoprotein (IDL).
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles Day 0, Week 2, 6 (Baseline), 10, 12 Participants were required to fast for 12 hours prior to sampling for lipid profile which included following parameters: total, large, medium and small HDL-C particles.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) Day 0, Week 6 (Baseline), 12 DAS28-3 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the CRP (milligram per liter \[mg/L\]). DAS28-3 (CRP) less than or equal to (\<=)3.2 indicated low disease activity, DAS28-3 (CRP) more than (\>) 3.2 to 5.1 indicated moderate to high disease activity.
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) Day 0, Week 6 (Baseline), 12 DAS28-4 (CRP) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, C-reactive protein (CRP) \[mg/L\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 \[CRP\] \<=3.2 indicated low disease activity, DAS28-4 \[CRP\] \>3.2 to 5.1 indicated moderate to high disease activity and DAS28 less than 2.6 indicates remission.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) Day 0, Week 6 (Baseline), 12 DAS28-3 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]). DAS28-3 (ESR) \<=3.2 indicated low disease activity, DAS28-3 (ESR) \>3.2 to 5.1 indicated moderate to high disease activity.
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Day 0, Week 6 (Baseline), 12 DAS28-4 (ESR) was calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) \[mm/hr\] and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging from 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28-4 (ESR) \<=3.2 indicated low disease activity, DAS28-4 (ESR) \>3.2 to 5.1 indicated moderate to high disease activity.
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response Week 6 (Baseline), 12 ACR20 responses were defined as greater than or equal to 20% improvement in tender or swollen joint counts and 20% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response Week 6 (Baseline), 12 ACR50 responses were defined as greater than or equal to 50% improvement in tender or swollen joint counts and 50% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response Week 6 (Baseline), 12 ACR70 responses were defined as greater than or equal to 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the 5 remaining ACR-core set measures: 1) physician's global assessment of disease activity, 2) participants assessment of disease activity, 3) participants assessment of pain, 4) participants assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.
Tender-Joint Count Day 0, Week 6 (Baseline), 12 Tender joint count (TJC) is an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
Swollen-Joint Count Day 0, Week 6 (Baseline), Week 12 Swollen joint count (SJC): an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (for artificial joints).
C-Reactive Protein (CRP) Day 0, Week 6 (Baseline), 12 The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range is 1-3 milligram per liter (mg/L).
Erythrocyte Sedimentation Rate (ESR) Day 0, Week 6 (Baseline), 12 ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
Patient Assessment of Arthritis Pain Day 0, Week 6 (Baseline), 12 Participants assessed the severity of their arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). The scale ranged from 0 (no pain) to 100 (most severe pain), measurement on a scale corresponds to the magnitude of their pain.
Physician's Global Assessment (PhysGA) of Arthritis Pain Day 0, Week 6 (Baseline), Week 12 The physician evaluated participants disease signs, functional capacity and physical examination independent of the patient's global assessment of arthritis. Physician's response was recorded using 0-100 mm visual analog scale (VAS), where 0=no pain and 100=most severe pain.
Patient's Global Assessment (PtGA) of Arthritis Pain Day 0, Week 6 (Baseline), Week 12 Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0-100 mm visual analog scale where 0=no pain and 100=most severe pain.
Health Assessment Questionnaire Disability Index (HAQ-DI) Day 0, Week 6 (Baseline), 12 HAQ-DI: participant-reported assessment of ability to perform tasks in 8 functional categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, 0=least functional difficulty and 3=extreme functional difficulty.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇰🇷Seoul, Korea, Republic of