|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
28 August 2023 |
|
Main ID: |
EUCTR2020-003874-30-DK |
|
Date of registration:
|
23/11/2020 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® dose
|
|
Scientific title:
|
A 2-year follow-up study to assess cognition and health-related quality of
life in participants with highly-active relapsing multiple sclerosis, having
participated in the CLARIFY MS trial - CLARIFY MS Extension |
|
Date of first enrolment:
|
06/04/2021 |
|
Target sample size:
|
380 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003874-30 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Ambispective; data from patients participating to past trials. No IMP treatment during this study If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no
|
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
|
|
|
Countries of recruitment
|
|
Austria
|
Czech Republic
|
Denmark
|
Hungary
|
Italy
|
Slovakia
| | |
|
Contacts
|
|
Name:
|
Nektaria Alexandri
|
|
Address:
|
Frankfurter Str. 250
64293
Darmstadt
Germany |
|
Telephone:
|
491511454 3196 |
|
Email:
|
|
|
Affiliation:
|
Merck Healthcare KGaA |
|
|
Name:
|
Nektaria Alexandri
|
|
Address:
|
Frankfurter Str. 250
64293
Darmstadt
Germany |
|
Telephone:
|
491511454 3196 |
|
Email:
|
|
|
Affiliation:
|
Merck Healthcare KGaA |
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Highly-active relapsing multiple sclerosis
MedDRA version: 20.0
Level: SOC
Classification code 10029205
Term: Nervous system disorders
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1
Level: PT
Classification code 10028245
Term: Multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0
Level: PT
Classification code 10080700
Term: Relapsing multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
|
|
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
|
|
Intervention(s)
|
Trade Name: Mavenclad
Product Name: Cladribine tablets
Product Code: Not applicable
Pharmaceutical Form: Tablet
|
|
Primary Outcome(s)
|
|
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)
|
|
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
|
|
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
|
|
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(s)
|
Timepoint(s) of evaluation of this end point: CLARIFY visit 1, defined as 36 months (+/-28 days) after initial Mavenclad dose
CLARIFY end of study visit defined as 48 months (+/-28 days) after initial Mavenclad dose, or early discontinuation visit
|
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)
• 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
|
|
Secondary ID(s)
|
|
MS700568_0158
|
|
2020-003874-30-CZ
|
|
Source(s) of Monetary Support
|
|
Merck Healthcare KGaA
|
|
Ethics review
|
Status: Approved
Approval date: 06/04/2021
Contact:
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|