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

November 14, 2012 updated by: Pfizer

Phase 2 Study Of The Effects Of Open-Label CP-690,550 And Double-Blind Atorvastatin On Lipids In Patients With Active Rheumatoid Arthritis

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 143-729
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 133-792
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35801
        • Pfizer Investigational Site
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Pfizer Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • Pfizer Investigational Site
    • California
      • Upland, California, United States, 91786
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Pfizer Investigational Site
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Pfizer Investigational Site
      • Mayfield Village, Ohio, United States, 44143
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29601
        • Pfizer Investigational Site
    • Texas
      • Allen, Texas, United States, 75013
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12
Time Frame: Baseline (Week 6), Week 12
Baseline (Week 6), Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Time Frame: Baseline (Week 6), Week 12
Baseline (Week 6), Week 12
12-Hours Fasting Lipid Profile
Time Frame: 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.
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
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
12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles
Time Frame: 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).
Day 0, Week 2, 6 (Baseline), 10, 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
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
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Time Frame: 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.
Day 0, Week 6 (Baseline), 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
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
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Time Frame: 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.
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
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
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response
Time Frame: 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.
Week 6 (Baseline), 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Time Frame: 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.
Week 6 (Baseline), 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Time Frame: 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.
Week 6 (Baseline), 12
Tender-Joint Count
Time Frame: 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).
Day 0, Week 6 (Baseline), 12
Swollen-Joint Count
Time Frame: 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).
Day 0, Week 6 (Baseline), Week 12
C-Reactive Protein (CRP)
Time Frame: 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).
Day 0, Week 6 (Baseline), 12
Erythrocyte Sedimentation Rate (ESR)
Time Frame: 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.
Day 0, Week 6 (Baseline), 12
Patient Assessment of Arthritis Pain
Time Frame: 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.
Day 0, Week 6 (Baseline), 12
Physician's Global Assessment (PhysGA) of Arthritis Pain
Time Frame: 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.
Day 0, Week 6 (Baseline), Week 12
Patient's Global Assessment (PtGA) of Arthritis Pain
Time Frame: 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.
Day 0, Week 6 (Baseline), Week 12
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: 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.
Day 0, Week 6 (Baseline), 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 28, 2010

First Submitted That Met QC Criteria

January 28, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Estimate)

December 13, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3921109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on CP-690,550

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe