International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS

Merck Serono International S.A.0 个研究点目标入组 100 人开始时间: 2008年6月10日最近更新: 2012年6月26日

适应症

试验速览

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•Males and females between 18 and 65 years of age
•Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
•-Post-menopausal or surgically sterile, or
•-Using a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner.
•Have RMS according to the revised McDonald Criteria 2005
•Have disease duration for at least 3 months
•Are currently receiving RNF 44mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening
•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) no
•F.1.3.1 Number of subjects for this age range

•Have any disease other than MS that could better explain his/her signs and symptoms
•Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the patient’s MS or the patient’s RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable
•Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug [DMD]s: immunomodulatory, immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study
•Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1
•Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
•Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
•Have moderate to severe renal impairment
•History of any chronic pain syndrome
•Any visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartTM

发起方

Merck Serono International S.A.