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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059864
• Other study ID #: A3921109
• Status: Completed
• Phase: Phase 2
• First received: January 28, 2010
• Last updated: November 14, 2012
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• Atorvastatin
Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily
• CP-690,550
12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12
• Atorvastatin Placebo
Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily

Locations

Country	Name	City	State
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
United States	Pfizer Investigational Site	Allen	Texas
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Dayton	Ohio
United States	Pfizer Investigational Site	Gilbert	Arizona
United States	Pfizer Investigational Site	Greenville	South Carolina
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Mayfield Village	Ohio
United States	Pfizer Investigational Site	Scottsdale	Arizona
United States	Pfizer Investigational Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12		Baseline (Week 6), Week 12	No
Secondary	Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12		Baseline (Week 6), Week 12	No
Secondary	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.	Day 0, Week 2, 6 (Baseline), 10, 12	No
Secondary	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.	Day 0, Week 2, 6 (Baseline), 10, 12	No
Secondary	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).	Day 0, Week 2, 6 (Baseline), 10, 12	No
Secondary	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.	Day 0, Week 2, 6 (Baseline), 10, 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Week 6 (Baseline), 12	No
Secondary	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.	Week 6 (Baseline), 12	No
Secondary	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.	Week 6 (Baseline), 12	No
Secondary	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).	Day 0, Week 6 (Baseline), 12	No
Secondary	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).	Day 0, Week 6 (Baseline), Week 12	No
Secondary	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).	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No
Secondary	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.	Day 0, Week 6 (Baseline), Week 12	No
Secondary	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.	Day 0, Week 6 (Baseline), Week 12	No
Secondary	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.	Day 0, Week 6 (Baseline), 12	No

External Links

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