A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)

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Autores
Categoría Estudio primario
Registro de estudiosclinicaltrials.gov
Año 2005

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

Este artículo es parte de los siguientes hilos de publicación
  • LITHE [tociLIzumab Safety and THE Prevention of Structural Joint Damage] (13 documentos)
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This 3 arm study will compare the safety and efficacy, with respect to a reduction in signs and symptoms and prevention of joint damage, of tocilizumab versus placebo, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized to receive tocilizumab 4 mg/kg IV, tocilizumab 8 mg/kg IV or placebo IV, every 4 weeks. All patients will also receive methotrexate, 10-25 mg/week. The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals. After completion of the 2 year study participants could participate in the optional 3 year open label extension phase (year 3 to 5).
Epistemonikos ID: 19ddb5ed1ab36169e619eeab66a6139182bcf07b
First added on: Nov 07, 2017