A phase III, randomised, double-blind, three-arm, placebo-controlled, multi-center study to evaluate the safety and efficacy of oral Cladribine in subjects with relapsing remitting multiple sclerosis - Oral Cladribine versus Placebo in RRMS

Merck Serono International S.A.0 个研究点目标入组 1,290 人开始时间: 2005年7月5日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•The subjects must fulfill all of the following criteria prior to Study Day 1:
•- Be male or female, between 18 and 65 years of age (inclusive, at time of informed consent)
•- Have definite MS according to the McDonald criteria
•- Have relapsing-remitting disease with one or more relapses within twelve months prior to Study Day 1
•- Must be clinically stable and not have had a relapse within 28 days prior to Study Day 1
•- Have MRI consistent with MS at the Pre-Study Evaluation, according to the Fazekas criteria
•- Have an EDSS from 0-5.5, inclusive
•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

•The subjects must not meet any of the following criteria:
•- Have Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS)
•- Prior use of Disease Modifying Drugs (DMDs) within the last three months prior to Study Day 1
•- Have previously failed treatment with two or more DMDs on the basis of efficacy (could have previously failed treatment based on tolerability and/or convenience)
•- Prior or current history of malignancy
•- History of persistent anemia, leukopenia, neutropenia, or thrombocytopenia after immunosuppressive therapy
•- Have platelet and absolute neutrophil counts below the lower limits of normal range within 28 days prior to Study Day 1
•- Have significant leukopenia (white blood cell count <0.5 times the lower limit of normal of the central laboratory) within 28 days prior to Study Day 1.

发起方

Merck Serono International S.A.