A Clinical Research Study for People with Relapsing Multiple Sclerosis

• Register: EUCTR
• Last refreshed on: 26 October 2021
• Main ID: EUCTR2017-002631-42-AT
• Date of registration: 11/01/2018
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: A Clinical Research Study for People with Relapsing Multiple Sclerosis
• Scientific title: A 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis
• Date of first enrolment: 19/02/2018
• Target sample size: 265
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002631-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion criteria

Inclusion criteria:
•Male or female subjects = 18 years old
•Highly active RMS as defined by:
-One relapse in the previous year and at least 1 T1 Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs)
-Two or more relapses in the previous year, whether on DMD treatment or not
•EDSS score =5.0

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 260
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
•Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab
•Positive test for hepatitis C or positive tests for hepatitis B infection: either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
•Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
•Currently receiving immunosuppressive or myelosuppressive therapy with, e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine or azathioprine, or chronic use of corticosteroids
•History of tuberculosis , presence of active tuberculosis, or latent tuberculosis
•Presence of signs of PML detected by MRI, clinical and/or biomarker evaluations
•Active malignancy
• lymphocyte count not within normal limits of the local hospital lab before initiation of first treatment course


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing multiple sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Trade Name: Mavenclad®
Product Name: Cladribine
Pharmaceutical Form: Tablet
INN or Proposed INN: CLADRIBINE
CAS Number: 4291-63-8
Current Sponsor code: EMD280922
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To determine the onset of action of Mavenclad®in subjects with highly active relapsing multiple sclerosis (RMS).

Timepoint(s) of evaluation of this end point: •At the end o 6 months compared to baseline

Primary end point(s): •Differences in the counts of combined unique active (CUA) MRI lesions lesions during the first 6 months (i.e. during periods months 1-6, 2-6, 3-6) compared to baseline (i.e. the period screening to baseline)

Secondary Objective: To assess the effect of Mavenclad® on different immune system composites in particular
cell subtypes count and repopulation

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: •At the end of 3, 6, 12, 15, 18 and 24 months compared to baseline

Secondary end point(s): •Characterization of immune cell subsets count

Secondary ID(s)

2017-002631-42-SE

MS700568_0022

Source(s) of Monetary Support

Merck KGaA

Ethics review

Status: Approved
Approval date: 12/02/2018
Contact: