Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01059864
First received: January 28, 2010
Last updated: November 14, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis |
Drug: CP-690,550 Drug: Atorvastatin Drug: Atorvastatin Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 [ Time Frame: Baseline (Week 6), Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline (Week 6), Week 12 ] [ Designated as safety issue: No ]
- 12-Hours Fasting Lipid Profile [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 2, 6 (Baseline), 10, 12 ] [ Designated as safety issue: No ]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]) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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]) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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]) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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]) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ] [ Designated as safety issue: No ]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) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 0, Week 6 (Baseline), Week 12 ] [ Designated as safety issue: No ]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) [ Time Frame: Day 0, Week 6 (Baseline), 12 ] [ Designated as safety issue: No ]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.
| Enrollment: | 111 |
| Study Start Date: | February 2010 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: CP-690,550
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Drug: Atorvastatin
Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
|
| Experimental: Arm 2 |
Drug: CP-690,550
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
Drug: Atorvastatin Placebo
Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059864
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35209 | |
| Pfizer Investigational Site | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Gilbert, Arizona, United States, 85234 | |
| Pfizer Investigational Site | |
| Scottsdale, Arizona, United States, 85251 | |
| United States, California | |
| Pfizer Investigational Site | |
| Upland, California, United States, 91786 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32216 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Dayton, Ohio, United States, 45417 | |
| Pfizer Investigational Site | |
| Mayfield Village, Ohio, United States, 44143 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Allen, Texas, United States, 75013 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 110-744 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 143-729 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 133-792 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 137-701 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01059864 History of Changes |
| Other Study ID Numbers: | A3921109 |
| Study First Received: | January 28, 2010 |
| Results First Received: | November 14, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
cholesterol lipids rheumatoid arthritis CP-690 550 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Atorvastatin |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013