Phase 2
Completed N=111
Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Source: ClinicalTrials.gov NCT01059864 ↗Enrolled (actual)
111
Serious AEs
1.4%
Results posted
Dec 2012
Primary outcomePrimary: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 — -35.34; 5.80 percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 |
-35.34; 5.80 | — |
| SECONDARY Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12 |
-51.49; 5.30 | — |
| SECONDARY 12-Hours Fasting Lipid Profile |
111.99; 114.68; 124.87; 132.94; 135.83; 138.26 | — |
| SECONDARY 12-Hours Fasting Lipid Profile: Particle Size of Lipoproteins |
42.08; 46.15; 47.41; 47.31; 44.75; 48.67 | — |
| SECONDARY 12-Hours Fasting Lipid Profile: Level of Lipoprotein Particles |
61.00; 56.20; 68.89; 65.24; 73.23; 65.51 | — |
| SECONDARY 12-Hours Fasting Lipid Profile: Level of High Density Lipoprotein Cholesterol (HDL-C) Particles |
27.08; 29.58; 30.89; 33.68; 32.90; 35.44 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) |
5.38; 5.23; 3.44; 3.33; 3.06; 2.99 | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) |
— | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR]) |
— | — |
| SECONDARY Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
6.60; 6.44; 4.33; 4.26; 3.84; 3.81 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response |
76.0; 76.6; 82.6; 65.2 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response |
48.0; 42.6; 67.4; 45.7 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response |
20.0; 19.1; 34.8; 30.4 | — |
| SECONDARY Tender-Joint Count |
23.20; 21.38; 10.48; 10.99; 8.57; 7.83 | — |
| SECONDARY Swollen-Joint Count |
16.90; 15.34; 6.36; 5.68; 4.85; 5.15 | — |
| SECONDARY C-Reactive Protein (CRP) |
33.17; 22.25; 6.31; 3.34; 6.04; 3.32 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
69.76; 60.32; 37.42; 29.98; 34.43; 30.31 | — |
| SECONDARY Patient Assessment of Arthritis Pain |
65.66; 64.41; 30.18; 31.26; 25.72; 29.09 | — |
| SECONDARY Physician's Global Assessment (PhysGA) of Arthritis Pain |
63.28; 65.38; 30.80; 31.85; 24.30; 29.70 | — |
| SECONDARY Patient's Global Assessment (PtGA) of Arthritis Pain |
68.10; 61.67; 27.66; 28.08; 23.33; 24.15 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) |
1.54; 1.46; 0.88; 0.88; 0.74; 0.92 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01059864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.