A Clinical Research Study for People with Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing multiple sclerosis; 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: EUCTR2017-002631-42-BE
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous exposure to drugs such as fingolimod, natalizumab, alemtuzumab, mitoxantrone and ocrelizumab
•Positive hepatitis C or hepatitis B surface antigen test and/or hepatits B core antibody test for IgG and/or IgM
•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
•Evidence or suspect of PML in MRI
•Active malignancy or history of malignancy
• lymphocyte count not within normal limits of the local hospital lab before initiation of first treatment course

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the onset of action of Mavenclad®in subjects with highly active relapsing multiple sclerosis (RMS).;Secondary Objective: Characterization of immune cell subsets count at the end of 3, 6, 12, 15, 18 and 24 months compared to baseline;Primary end point(s): •Difference in the counts of combined unique active (CUA) MRI lesions ;Timepoint(s) of evaluation of this end point: •At the end o 6 months compared to baseline

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Characterization of immune cell subsets count ;Timepoint(s) of evaluation of this end point: •At the end of 3, 6, 12, 15, 18 and 24 months compared to baseline