EUCTR2019-000069-19-AT
Active, not recruiting
Phase 1
Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS
Merck, S.L.0 sites1,000 target enrollmentJune 6, 2019
ConditionsMultiple SclerosisMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsMAVENCLAD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Merck, S.L.
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For Main Study and MRI Sub\-Study:
- •1\. Patients with MS randomised in CLARITY/CLARITY\-EXT clinical trial(s) who have received \= 1 course of IMP (Cladribine Tablets or placebo).
- •Patients with their FCDE randomised in ORACLE MS clinical trial who have received
- •\= 1 course of IMP (Cladribine Tablets or placebo).
- •2\. Patients can give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and this protocol.
- •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 920
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Main study:
- •Any condition, including any uncontrolled disease state other than MS, that in the Investigator’s
- •opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that
- •could interfere with the study objectives, conduct, or evaluation. If a patient is experiencing a confirmed or suspected relapse at the time of screening, the Medical Monitor is to be consulted to agree on a stabiliyation period (estimated to be between 4 weeks and 3 months) before Study Visit 1\.
- •MRI\-Substudy:
- •a. Female study participants who are pregnant
- •b.Patients were administered Cladribine Tablets through prescription or as part of another study within 6 month period before enrolment in the MRI Sub\-Study (i.e. patients participating in a clinical trial or observation study within the 6 month period before enrolment in the MRI Sub\-study, but do not receive Cladribine Tablets as part of these studies, are allowed to participate in the sub\-study).
Outcomes
Primary Outcomes
Not specified
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