Status: Recruiting

Official Title: A single-arm, open-label study of the safety and reduction of signs and symptoms during treatment with tocilizumab in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis

Brief Summary: This single arm, open-label study will assess the safety and efficacy with regard to reduction of signs and symptoms of treatment with tocilizumab in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8mg/kg iv, every 4 weeks and methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is <500 individuals.

Study Phase: 3

Study Type: Interventional; Prevention; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: tocilizumab [RoActemra]

• patients >=18 years with moderate to severe active RA for at least 6 months;
• swollen joint count >=6 (66 joint count) and tender joint count >=8 (68 joint count) at screening;
• inadequate response to stable dose of MTX;
• patients of reproductive potential must be using a reliable means of contraception.

• rheumatic autoimmune disease other than RA;
• patients with functional class IV RA;
• diagnosis of juvenile idiopathic or rheumatoid arthritis before age 16 or a history of current inflammatory joint disease other than RA;
• prior treatment failure with anti-tumor necrosis factor agent;
• pregnant or breastfeeding women.

This trial will be conducted at the following locations:

• CARTAGO 0
• SAN JOSE
• HEREDIA
• SAN JOSE

• MEDELLIN 0
• BOGOTA
• BARRANQUILLA
• BOGOTA
• BUCARAMANGA
• BOGOTÁ
• BARRANQUILLA
• BOGOTA
• CHÍA
• MEDELLÍN
• BOGOTA
• CALI
• BOGOTA

• JESUS MARIA
• SAN ISIDRO
• LIMA
• AREQUIPA

• BUENOS AIRES C1426AAL
• BUENOS AIRES
• CÓRDOBA
• TUCUMAN
• BUENOS AIRES
• SAN MIGUEL DE TUCUMAN

• SAN LUIS POTOSI 78240
• MEXICO CITY
• MEXICO CITY
• CHIHUAHUA
• OBREGON
• MEXICO CITY
• MEXICO CITY
• GUADALAJARA
• MORELIA
• MONTERREY
• MEXICO CITY
• MEXICO CITY
• QUERETARO
• MEXICO CITY
• MIEXICO CITY

• SANTIAGO 7500000
• SANTIAGO
• SANTIAGO
• CONCEPCION
• TEMUCO
• SANTIAGO
• SANTIAGO
• SANTIAGO
• SANTIAGO

• MONTEVIDEO 11000

• BARQUISIMETO 3005
• CARACAS
• CARACAS
• MARACAIBO

• QUITO 1394
• GUAYAQUIL
• QUITO
• CUENCA
• CUENCA

• SALVADOR 40050-410
• SAO PAULO
• CURITIBA
• FLORIANOPOLIS
• FORTALEZA
• RECIFE
• SAO PAULO
• SAO PAULO
• RIO DE JANEIRO
• BRASILIA
• CAMPINAS
• RIBEIRÃO PRETO
• PORTO ALEGRE
• PORTO ALEGRE
• RIO DE JANEIRO
• SÃO JOSÉ DO RIO PRETO
• VITORIA
• CAMPINAS
• BELO HORIZONTE
• SANTO ANDRE
• JUIZ DE FORA
• CAXIAS DO SUL
• CAIXA