Status:
COMPLETED
Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cogni...
Eligibility Criteria
Inclusion
- Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
- Received at least a single dose of cladribine tablets in the CLARIFY MS study
- Completed the Final Study Visit (M24) of the CLARIFY MS study
- Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
Exclusion
- Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
- Participation in other studies.
Key Trial Info
Start Date :
February 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT04776213
Start Date
February 23 2021
End Date
June 20 2023
Last Update
May 28 2024
Active Locations (60)
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1
Eva Maida
Vienna, Austria
2
FN u sv. Anny Brno
Brno, Czechia
3
FN Hradec Králové
Hradec Králové, Czechia
4
Nemocnice Jihlava, p.o.
Jihlava, Czechia