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 sites1,148 target enrollmentAugust 11, 2011

Overview

No summary available.

Registry

who.int

Start Date

August 11, 2011

End Date

October 25, 2018

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Merck Serono S.A. - Geneva

•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\.
•All subjects in the target population described in section 5\.1 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 2175
•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.