This 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. In Part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. In Part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
132
Administered by intravenous infusion, 8 mg/kg every 4 weeks.
Placebo to tocilizumab administered by intravenous infusion every 4 weeks.
Administered orally or parenterally, 7.5-25 mg weekly.
Change From Baseline in Small Low Density Lipoprotein (sLDL) Particle Numbers
Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.
Time frame: Baseline and Week 12
Change From Baseline to Week 12 in Aortic Pulse Wave Velocity (PWV)
Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.
Time frame: Baseline and Week 12
Change From Baseline to Week 24 in Small Low Density Lipoprotein (sLDL) Particle Numbers
Small LDL particles are associated with an increased risk of cardiovascular disease: more of these small particles lead to a greater risk. The concentration of fasting small LDL particles was determined using the Nuclear Magnetic Resonance (NMR) methodology.
Time frame: Baseline and Week 24
Change From Baseline to Week 24 in Aortic Pulse Wave Velocity (PWV)
Aortic (central) arterial stiffness was assessed with Pulse Wave Analysis (PWA) of the radial artery and carotid-femoral PWV using applanation tonometry after the patient had rested in a supine position for at least 10 minutes.
Time frame: Baseline and Week 24
Number of Participants Experiencing Adverse Events (AEs)
A severe AE is an event in which the intensity of the event results in an inability to work or perform normal daily activity. A Serious AE is fatal, life-threatening, requires in-patient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant or requires intervention to prevent one of the above outcomes. AEs of special interest include infection, gastrointestinal, infusion reaction (occurring during or within 24 hours of infusion), hepatic disorder, myocardial infarction and stroke.
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Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States
Advanced Arthritis Care & Research
Scottsdale, Arizona, United States
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States
Pacific Arthritis Care Center
Los Angeles, California, United States
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, United States
Science and Research Institute, Inc.
Jupiter, Florida, United States
Arthritis Center Palm Harbor
Palm Harbor, Florida, United States
Arthritis Rsrch of Florida, Inc.
Palm Harbor, Florida, United States
Sarasota Arthritis Center; Research Dept
Sarasota, Florida, United States
...and 30 more locations
Time frame: Up to Week 24