Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry

Merck Serono S.A. - Geneva0 个研究点目标入组 2,175 人开始时间: 2011年4月13日最近更新: 2019年2月28日

试验速览

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•The registry target population includes all subjects who participated in Sponsor oral cladribine Phase I to III clinical trials in MS associated with a protocol approved prior to the time of submission of the marketing application and completed (last patient, last visit) after November 2008. This corresponds to five clinical trials (protocols number 25643, 26593, 27820, 27967 and 28821) and 2175 subjects.
•All subjects in the target population will be eligible for enrollment in the registry once their participation in the clinical trial has ended. The following inclusion criteria must be fulfilled:
•Prior enrollment into selected clinical trials, regardless of randomization to either IMP or placebo, once participation in the clinical trial or in the clinical trial extension has ended
•Written informed consent is given
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2159
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 16

•The following reasons will exclude subjects from registry participation:
•Subjects who cannot be reached by phone;
•Subjects who are unable to answer the registry questionnaires and who do not have a next of kin or caregiver available to answer the registry questionnaires;
•Subjects who – either during the lag interval or subsequently – enter an interventional study.

发起方

Merck Serono S.A. - Geneva