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Evaluation of the Onset of Action in Highly Active Multiple Sclerosis (MS)

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ClinicalTrials.gov Identifier: NCT03364036
Recruitment Status : Recruiting
First Posted : December 6, 2017
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:
The main purpose of the study is to determine the onset of Mavenclad® action by frequent magnetic resonance imaging (MRI) assessment of the combined unique active (CUA) lesions in subjects with highly active relapsing multiple sclerosis (RMS).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Mavenclad® Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-year Prospective Study to Evaluate the Onset of Action of Mavenclad® in Subjects With Highly Active Relapsing Multiple Sclerosis
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cladribine

Arm Intervention/treatment
Experimental: Mavenclad® Drug: Mavenclad®
Subjects will receive Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
Other Name: Cladribine




Primary Outcome Measures :
  1. Change From Baseline in Counts of Combined Unique Active (CUA) Magnetic Resonance Imaging (MRI) Lesions at Month 6 [ Time Frame: Baseline, Month 6 ]

Secondary Outcome Measures :
  1. Change From Baseline in Counts of Immune Cell Subsets at Month 3, 6, 12, 15, 18 and 24 [ Time Frame: Baseline, Month 3, 6, 12, 15, 18 and 24 ]
    Immune cell subsets will be analyzed by flow cytometry analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Highly active RMS as defined by:
  • One relapse in the previous year and at least 1 T1 Gadolinium (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.
  • Expanded Disability Status Scale (EDSS) score less than equals to (<=) 5.0.
  • Other protocol defined inclusion criteria could apply.

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 immunoglobulin G (IgG) and/or immunoglobulin M (IgM).
  • Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result.
  • Currently receiving immunosuppressive or myelosuppressive therapy with, for example, 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 Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
  • Active malignancy or history of malignancy.
  • Other protocol defined exclusion criteria could apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03364036


Contacts
Contact: Merck KGaA Communication Center +49 6151 72 5200 service@merckgroup.com

Locations
Germany
Merck KGaA Communication Center Recruiting
Darmstadt, Germany, 64293
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT03364036     History of Changes
Other Study ID Numbers: MS700568_0022
2017-002631-42 ( EudraCT Number )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Merck KGaA:
Multiple sclerosis
Mavenclad ®
Cladribine

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Cladribine
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs