A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors

Completed · Phase 4

Conditions studied: Rheumatoid Arthritis

In brief

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of cardiovascular events with tocilizumab in comparison to etanercept in participants with rheumatoid arthritis (RA). Participants will be randomized to receive intravenous (IV) 8 milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 milligrams (mg) etanercept weekly, with or without non-biologic disease-modifying anti-rheumatic drug (DMARD).

Key facts

Study ID

NCT01331837

Run by

Hoffmann-La Roche

People needed

3080

Starts

2011-08-02

Expected to finish

2016-03-25

Last updated by the study team

2017-07-13

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with moderate to severe RA of greater than or equal to (>=6) months duration
• Inadequate response to at least one non-biologic DMARD
• Positive for Rheumatoid Factor (RF) and/or anti-cyclic citrullinated peptide (CCP) antibodies at screening
• Have C-reactive protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL) at screening or at the baseline visit
• Swollen joint count (SJC) >=8 (66 joint count) and tender joint count (TJC) >= 8 (68 joint count) during screening or at the baseline visit
• History of Coronary Heart Disease (CHD) or presence of one or more additional CHD risk factors, including current cigarette smoking, hypertension, low High Density Lipoprotein (HDL) cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis
• At the time of randomization, will have discontinued infliximab, adalimumab, golimumab, or certolizumab for >= 4 weeks

You may not qualify if…

• Major surgery (including joint surgery or coronary revascularization) within 8 weeks prior to screening or planned major surgery within 1 year of study start
• Rheumatic autoimmune disease other than RA
• History of or current inflammatory joint disease other than RA
• Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (myocardial infarction, revascularization, stroke, transient ischemic attack, or acute coronary syndrome)
• Current or previous (within the past 2 years) evidence of serious uncontrolled concomitant pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or gastrointestinal disease
• Uncontrolled disease states, such as asthma or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
• Pre-existing central nervous system demyelinating or seizure disorders
• History of diverticulitis, diverticulosis requiring treatment or other lower gastrointestinal tract conditions that might predispose to perforations
• Current liver disease as determined by the investigator; a history of asymptomatic elevations in liver function tests (LFTs) is not considered an exclusion
• Active current infection or history of recurrent bacterial, viral, fungal, mycobacterial or other infections, including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds
• Any major episode of infection requiring hospitalization or treatment with IV antibiotics within four weeks of screening or oral antibiotics within two weeks prior to screening visit
• Active tuberculosis (TB) requiring treatment within 3 years prior to baseline
• Latent TB diagnosed during screening that has not been appropriately treated
• Primary or secondary immunodeficiency (history of or currently active)
• Moderate to severe heart failure
• Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematologic malignancies and solid tumors, except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
• Breast feeding mothers
• History of alcohol, drug or chemical abuse within the 6 months prior to screening
• Participants with lack of peripheral venous access
• Participants with a history of allergic reactions to latex
• Previous treatment with non-tumor necrosis factor (non-TNF)-inhibitor biologic therapy
• Treatment with any investigational agent within 4 weeks of screening visit
• Treatment with any cell depleting therapies within 1 year of baseline
• Treatment with IV gamma globulin, plasmapheresis or Prosorba column within 6 months of baseline visit
• Immunization with a live/attenuated vaccine within 4 weeks prior to baseline visit

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Clinical and Translational Research Center of Alabama, PC — Tuscaloosa, Alabama, United States
• Arizona Arthritis & Rheumatology Associates, P.C. — Glendale, Arizona, United States
• Arizona Arthritis & Rheumatology Research, Pllc — Paradise Valley, Arizona, United States
• Sun Valley Arthritis Center — Peoria, Arizona, United States
• Valley Arthritis Care — Phoenix, Arizona, United States
• Advanced Arthritis Care & Research — Scottsdale, Arizona, United States
• Camp Lowell Medical Specialists — Tucson, Arizona, United States
• The University of Arizona — Tucson, Arizona, United States
• NEA Baptist Clinic — Jonesboro, Arkansas, United States
• OrthoArkansas; Orthopedics & Sports Medicine — Little Rock, Arkansas, United States
• Samy Metyas, MD, Inc — Covina, California, United States
• Talbert Medical Group — Huntington Beach, California, United States
• Allergy & Rheumatology Medical Clinic, Inc — La Jolla, California, United States
• Valerius Medical Group — Los Alamitos, California, United States
• Clinical Interventions Research Institute — Mission Viejo, California, United States
• Dr. Brigid Freyne, MD — Murrieta, California, United States
• Sharp Rees-Stealy Medical Group — Poway, California, United States
• San Diego Arthritis Med Clnc — San Diego, California, United States
• Purushotham & Akther Kotha Inc — San Diego, California, United States
• C Michael Neuwelt MD Inc — San Leandro, California, United States
• Pacific Arthritis Ctr Med Grp — Santa Maria, California, United States
• Orrin M. Troum, Md — Santa Monica, California, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• Uni Of Alabama,Birmingham; Medicine - Rheumatology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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