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Clinical Trials/EUCTR2009-017978-21-SE
EUCTR2009-017978-21-SE
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 enrollmentMay 3, 2011
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ConditionsMultiple Sclerosis patients who have participated in cladribine tablets clinical trialsMedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]

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
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 3, 2011
End Date
October 25, 2018
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Merck Serono S.A. - Geneva

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
  • •F.1\.3\.1 Number of subjects for this age range 16

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, not recruiting
Phase 1
ong-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsMultiple Sclerosis patients who have participated in cladribine tablets clinical trialsMedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2009-017978-21-ITMERCK SERONO SA1,148
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
EUCTR2009-017978-21-PTMerck Serono S.A. - Geneva1,148
Active, not recruiting
Phase 1
ong-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials
EUCTR2009-017978-21-GBMerck Serono S.A. - Geneva1,148
Active, not recruiting
Phase 1
ong-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsMultiple Sclerosis patients who have participated in cladribine tablets clinical trialsMedDRA version: 18.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2009-017978-21-BGMerck Serono S.A. - Geneva2,175
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Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE RegistryMultiple Sclerosis patients who have participated in cladribine tablets clinical trialsMedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2009-017978-21-PLMerck Serono S.A. - Geneva1,148