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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
111
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Huntsville, Alabama, United States
Pfizer Investigational Site
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
Time frame: Baseline (Week 6), 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
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.
Time frame: Day 0, Week 2, 6 (Baseline), 10, 12
12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins
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.
Time frame: Day 0, Week 2, 6 (Baseline), 10, 12
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
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).
Time frame: Day 0, Week 2, 6 (Baseline), 10, 12
12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles
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.
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Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
Gilbert, Arizona, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Upland, California, United States
Pfizer Investigational Site
Jacksonville, Florida, United States
Pfizer Investigational Site
Dayton, Ohio, United States
Pfizer Investigational Site
Mayfield Village, Ohio, United States
Pfizer Investigational Site
Greenville, South Carolina, United States
Pfizer Investigational Site
Allen, Texas, United States
...and 5 more locations
Time frame: Day 0, Week 2, 6 (Baseline), 10, 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
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.
Time frame: Day 0, Week 6 (Baseline), 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
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.
Time frame: Day 0, Week 6 (Baseline), 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
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.
Time frame: Day 0, Week 6 (Baseline), 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
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.
Time frame: Day 0, Week 6 (Baseline), 12
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
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.
Time frame: Week 6 (Baseline), 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
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.
Time frame: Week 6 (Baseline), 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
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.
Time frame: Week 6 (Baseline), 12
Tender-Joint Count
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).
Time frame: Day 0, Week 6 (Baseline), 12
Swollen-Joint Count
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).
Time frame: Day 0, Week 6 (Baseline), Week 12
C-Reactive Protein (CRP)
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).
Time frame: Day 0, Week 6 (Baseline), 12
Erythrocyte Sedimentation Rate (ESR)
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.
Time frame: Day 0, Week 6 (Baseline), 12
Patient Assessment of Arthritis Pain
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.
Time frame: Day 0, Week 6 (Baseline), 12
Physician's Global Assessment (PhysGA) of Arthritis Pain
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.
Time frame: Day 0, Week 6 (Baseline), Week 12
Patient's Global Assessment (PtGA) of Arthritis Pain
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.
Time frame: Day 0, Week 6 (Baseline), Week 12
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
Time frame: Day 0, Week 6 (Baseline), 12