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Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

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ClinicalTrials.gov Identifier: NCT03369665
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Merck KGaA

Brief Summary:
The main purpose of the study is to assess the health-related quality of life (HRQoL) through the Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) scale in highly-active relapsing multiple sclerosis (RMS) subjects treated with Mavenclad® for 2 years (24 months).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 445 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad®
Actual Study Start Date : June 20, 2018
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : November 25, 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 Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Scale Score at Month 24 [ Time Frame: Baseline, Month 24 ]

Secondary Outcome Measures :
  1. Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6 [ Time Frame: Month 6 ]


Information from the National Library of Medicine

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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:

  • Positive hepatitis C or hepatitis B surface antigen test and/or 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
  • Presence of Progressive Multifocal Leukoencephalopathy (PML) in Magnetic Resonance Imaging (MRI).
  • Active 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): NCT03369665


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

Locations
Germany
Merck KGaA Communication Center Recruiting
Darmstadt, Germany, 64293
Contact    +49 6151 72 5200    service@merckgroup.com   
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Medical Responsible Merck KGaA

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT03369665     History of Changes
Other Study ID Numbers: MS700568_0021
2017-002632-17 ( EudraCT Number )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: July 6, 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
Health-related Quality of Life

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