EUCTR2009-017978-21-PL
Active, not recruiting
Phase 1
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 enrollmentMarch 6, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
- Sponsor
- Merck Serono S.A. - Geneva
- Enrollment
- 1148
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •The following two 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 able to answer the registry questionnaires;
- •Subjects who \- either during the lag interval or subsequently \- enter an interventional study.
Outcomes
Primary Outcomes
Not specified
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