Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01059864
First received: January 28, 2010
Last updated: November 14, 2012
Last verified: November 2012

January 28, 2010
November 14, 2012
February 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Percent change in LDL level compared to baseline (Wk 6) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01059864 on ClinicalTrials.gov Archive Site
  • 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.
  • Absolute change in LDL level compared to baseline (Week 6) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • 12-hour fasting lipids, including but not limited to total cholesterol, LDL C, HDL C, VLDL C, non HDL C, apolipoproteins A 1 and B, lipoprotein particle size and pool size and triglycerides [ Time Frame: At each timepoint ] [ Designated as safety issue: Yes ]
  • RA related efficacy endpoints including DAS28 3 and DAS28 4 (CRP and ESR), ACR response rates and their components: joint counts, HAQ DI, patient & physician VAS scales, CRP and ESR [ Time Frame: Pretreatment, Wk 6 and Wk 12 ] [ Designated as safety issue: No ]
  • Clinical safety laboratory testing (hematology, chemistry, urinalysis), physical exam and vital signs (complete & targeted physical examination, electrocardiogram, blood pressure and temperature), and assessment of adverse events [ Time Frame: At each timepoint ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • Drug: Atorvastatin Placebo
    Starting at Week 6 and continuing through Week 12 atorvastatin placebo tablets administered once daily
  • Experimental: Arm 1
    Interventions:
    • Drug: CP-690,550
    • Drug: Atorvastatin
  • Experimental: Arm 2
    Interventions:
    • Drug: CP-690,550
    • Drug: Atorvastatin Placebo
McInnes IB, Kim HY, Lee SH, Mandel D, Song YW, Connell CA, Luo Z, Brosnan MJ, Zuckerman A, Zwillich SH, Bradley JD. Open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis. 2014 Jan;73(1):124-31. doi: 10.1136/annrheumdis-2012-202442. Epub 2013 Mar 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of
 
NCT01059864
A3921109
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP