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



Status:Completed
Conditions:Arthritis, Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Rheumatology
Healthy:No
Age Range:50 - Any
Updated:8/3/2016
Start Date:August 2011
End Date:June 2016

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A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)

This randomized, open-label, parallel-group, multicenter study will evaluate the rate of
cardiovascular events of tocilizumab in comparison to etanercept in participants with
rheumatoid arthritis. Participants will be randomized to receive intravenous (IV) 8
milligrams per kilogram (mg/kg) tocilizumab every 4 weeks or subcutaneous 50 mg etanercept
weekly, with or without non-biologic disease modifying anti-rheumatic drug (DMARD). The
anticipated time on study drug is up to 5 years.


Inclusion Criteria:

- Male and female participants, greater than or equal to (>/=) 50 years of age

- Participants with moderate to severe rheumatoid arthritis of >/=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 a C-Reactive Protein (CRP) greater than (>) 0.3 milligrams per deciliter (mg/dL)
at screening or at the baseline visit

- Swollen joint count (SJC) and Tender joint count (TJC) >/= 8 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

- Females of childbearing potential must have a negative pregnancy test within 28 days
of randomization and must be ready to use reliable contraceptive methods

Exclusion Criteria:

- 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 rheumatoid arthritis

- History of, or current, inflammatory joint disease other than rheumatoid arthritis

- 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
intravenous (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 six months prior to screening

- Participants with lack of peripheral venous access

- Participants with a history of allergic reactions to latex

- Previous treatment with non-TNF-inhibitor biologic therapy

- Treatment with any investigational agent within four 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 six
months of baseline visit

- Immunization with a live/attenuated vaccine within four weeks prior to baseline visit

- Any previous treatment with alkylating agents, such as cyclophosphamide or
chlorambucil, or with total lymphoid irradiation
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