Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose

Phase 1

• Conditions: Highly-active relapsing multiple sclerosis; MedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 21.0Level: PTClassification code 10080700Term: Relapsing multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-003874-30-AT
• Lead Sponsor: Merck Healthcare KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-23
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

1. Participants having participated in the CLARIFY MS trial, who:
a. Have at least CLARIFY MS Baseline data on SDMT;
b. Received at least a single dose of cladribine tablets in the CLARIFY MS trial; and
c. Completed the Final Study Visit (M24) of the CLARIFY MS trial.
2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (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 378
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study.
2. Participation in other studies/trials.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess cognitive impairment in participants with highly-active relapsing multiple sclerosis (RMS), having participated to the CLARIFY MS trial, at 4 years after initial dose of cladribine tablets;Secondary Objective: To assess health related quality of life (HRQoL) in participants with highly-active RMS, having participated in the CLARIFY MS trial, at 4 years after initial dose of cladribine tablets;Primary end point(s): Percentage of participants with no or minimal decline in cognitive function, defined as an improved or stable Symbol Digit Modalities Test (SDMT) scorea or a decline of 4 points or less in the SDMT score, at 4 years after initial dose of cladribine tablets (M48) compared to SDMT score prior to initial dose of cladribine tablets (CLARIFY MS Baseline);Timepoint(s) of evaluation of this end point: CLARIFY end of study visit defined as 48 months (+/-28 days) after initial Mavenclad dose, or early discontinuation visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Change in HRQoL as measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) physical and mental health scores at 4 years after initial dose of cladribine tablets (M48) compared to prior to initial dose of cladribine tablets (CLARIFY MS Baseline)<br><br>• Change in HRQoL as measured by MSQoL-54 physical and mental health scores at 4 years after initial dose of cladribine tablets (M48) compared to M24;Timepoint(s) of evaluation of this end point: CLARIFY visit 1, defined as 36 months (+/-28 days) after initial Mavenclad dose<br>CLARIFY end of study visit defined as 48 months (+/-28 days) after initial Mavenclad dose, or early discontinuation visit