EUCTR2006-000606-23-ES进行中（未招募）1 期
Post-authorization safety study to check the potential association between the safetyprofile of beta interferon 1a and the body mass index or pharmacodynamics during thetitration phase - PASS-PD del escalado de dosis de Rebif
Merck, S.L.0 个研究点目标入组 0 人开始时间: 2012年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 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
- •1.El paciente tiene EM recidivante
- •2.Asignación a un protocolo de tratamiento con interferón beta-1a a dosis altas.
- •3.Edad entre 18 y 60 años
- •4.El paciente tiene una puntuación en la EDSS <5,5.
- •5.Uno o más brotes en el año previo.
- •6.Contracepción eficaz.
- •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 84
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.EM primaria progresiva o EM secundaria progresiva sin recidivas superpuestas.
- •2.Tratamiento previo con interferón beta (beta-1b o beta-1a)
- •3.Embarazo o lactancia.
- •4.Tratamiento previo con inmunomoduladores o inmunosupresors.
- •5.Alteraciones hematológicas o hepáticas importantes (clínicas o analíticas)
- •6.Enfermedad importante que interfiera con la valoración del estudio o con la realización del mismo.
- •7.Participación simultánea en otro estudio experimental.
- •8.Alergia conocida al producto o a sus excipientes.
研究者
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