Resumen

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).

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Ubicaciones

Centro de Investigaciones Reumatologicas y Osteologicas

Buenos Aires, Argentina

Organizacion Medica de Investigacion

Buenos Aires, Argentina

CEIM Consultorios Especializados en Investigaciones Médicas

Buenos Aires, Argentina

APRILLUS

Buenos Aires, Argentina

Instituto centenario

Buenos Aires, Argentina

Fundación CIDEA

Buenos Aires, Argentina

Atencion Integral En Reumatologia Buenos Aires

Buenos Aires, Argentina

CEMIC

Buenos Aires, Argentina

Hospital General de Agudos Dr. J. M. Ramos Mejia

Ciudad Autonoma Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina

Hospital Privado Cordoba

Cordoba Pcia, Argentina

Instituto Reumatológico Strusberg

Córdoba, Argentina

Hospital Italiano de Cordoba

Córdoba, Argentina

Hospital Municipal Nuestra Sra. de Lujan

Luján, Argentina

Centro de Investigacion Pergamino SA

Pergamino, Argentina

Sanatorio Parque de Rosario

Rosario, Argentina

Instituto Centralizado de Asistencia e Investigaci

Rosario, Santa Fe, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Centro de Investigaciones Médicas - CIM

San Juan Bautista, Argentina

Centro de Investigaciones Reumatologicas Tucuman

San Miguel de Tucumán, Argentina

Centro Médico Privado de Reumatología

San Miguel de Tucumán, Argentina

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)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Etanercept

Tocilizumab

Ubicaciones

Centro de Investigaciones Reumatologicas y Osteologicas

Organizacion Medica de Investigacion

CEIM Consultorios Especializados en Investigaciones Médicas

APRILLUS

Instituto centenario

Fundación CIDEA

Atencion Integral En Reumatologia Buenos Aires

CEMIC

Hospital General de Agudos Dr. J. M. Ramos Mejia

Hospital Britanico de Buenos Aires

Hospital Privado Cordoba

Instituto Reumatológico Strusberg

Hospital Italiano de Cordoba

Hospital Municipal Nuestra Sra. de Lujan

Centro de Investigacion Pergamino SA

Sanatorio Parque de Rosario

Instituto Centralizado de Asistencia e Investigaci

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

Centro de Investigaciones Médicas - CIM

Centro de Investigaciones Reumatologicas Tucuman

Centro Médico Privado de Reumatología

Patrocinadores