EUCTR2010-023841-31-ES进行中（未招募）不适用
Ensayo clínico fase III, de grupos paralelos, randomizado, controlado con placebo, doble ciego y multicéntrico, para evaluar la eficacia y seguridad de la administración de tocilizumab en pacientes diagnosticados de orbitopatía tiroidea (OT) moderada a severa o que amenaza la vista, que no han respondido adecuadamente al tratamiento con pulsos de corticoides.Efficacy and safety of tocilizumab in patients with moderate to severe or sight-threatening TAO, who have poor response to treatment with pulse steroids. Phase III clinical trial, randomized, placebo-controlled, double-blind, parallel groups and multicenter study.
Dr. Juan Jesús Gómez-Reino Carnota0 个研究点开始时间: 2011年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Pacientes diagnosticados de OT con un CAS 4 (en fase activa) y un índice de severidad, según EUGOGO, de moderado a severo o que amenaza la visión, después de recibir el tratamiento de pulsos de corticosteroides debido a:
- •oMala respuesta a los pulsos de corticosteroides, evaluada al final del tratamiento ó después del primer pulso de corticosteroides o
- •oRecurrencia de la OT, después del tratamiento con corticosteroides.
- •Cirugía de descompresión orbitaría no necesaria de un modo inmediato.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Fumador activo.
- •Pacientes tratados con radioiodo en los últimos seis meses.
- •Pacientes que se prevea que necesiten tratamiento con radioiodo o tiroidectomía durante el estudio.
- •Paciente embarazada o que pretenda estarlo, durante el tiempo que dure el estudio.
- •Antecedentes de infección activa recurrente o crónica.
- •Antecedentes de ulceración intestinal o diverticulitis.
- •Pacientes con historial de enfermedad hepática crónica o alteraciones hepáticas: valores de ALT o AST por encima de 5×LSN.
- •Historia positiva de VIH, hepatitis C o hepatitis B.
- •Recuento de neutrófilos menor de 0,5×109/L o un recuento de plaquetas de menos de 50×103/µL.
- •Uso simultáneo o contraindicaciones para el uso de agentes inmunosupresores.
- •A tratamiento con otro medicamento en investigación durante las cuatro semanas de selección o durante cinco vidas medias del medicamento en investigación.
- •Enfermedad cardiovascular o cerebrovascular clínicamente significativa.
- •Diabetes mellitus no controlada.
研究者
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