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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03369665
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

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

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 identifier (NCT number): NCT03369665

Contact: Merck KGaA Communication Center +49 6151 72 5200

Kepler Universitätsklinikum Recruiting
Linz, Austria, 4021
Principal Investigator: Michael Guger         
Hôpital Erasme Recruiting
Brussels, Belgium, 1070
Principal Investigator: Gaetano Perrotta         
Cliniques Univ. St.-Luc Recruiting
Brussels, Belgium, 1200
Principal Investigator: Vincent Van Pesch         
UZ Antwerpen Recruiting
Edegem, Belgium, 2650
Principal Investigator: Barbara Willekens         
Jessa Ziekenhuis Recruiting
Hasselt, Belgium, 3500
Principal Investigator: Nina De Klippel         
Clinique Saint Pierre Recruiting
Ottignies, Belgium, 1340
Principal Investigator: Philippe Jacquerye         
FN u sv. Anny Brno Recruiting
Brno, Czechia, 65691
Principal Investigator: Michel Dufek         
FN Hradec Kralove Recruiting
Chocen, Czechia, 56501
Principal Investigator: Martin Valis         
Nemocnice Jihlava, p.o. Recruiting
Jihlava, Czechia, 586 33
Principal Investigator: Radek Ampapa         
Aalborg Hospital Recruiting
Aalborg, Denmark, 9100
Principal Investigator: Claudia Pfleger         
Matthias Kant Recruiting
Sønderborg, Denmark, 6400
Principal Investigator: Matthias Kant         
Helsinki University Central Hospital Recruiting
Helsinki, Finland, 290
Principal Investigator: Annuka Uusitalo         
Terveystalo Mikkeli Recruiting
Mikkeli, Finland, 50100
Principal Investigator: Sakari Simula         
University of Debrecen Recruiting
Debrecen, Hungary, 4032
Principal Investigator: Tünde Csepany         
VALEOMED Kft Recruiting
Esztergom, Hungary, 2500
Principal Investigator: Maria Satori         
Hospital of Lithuanian University of Health Sciences Kaunas Recruiting
Kaunas, Lithuania, 50161
Principal Investigator: Antanas Vaitkus         
Klaipedos Ligonine Recruiting
Kaunas, Lithuania, 50161
Principal Investigator: Lina Malciene         
Vilnius University Hospital Santariskiu Clinics Recruiting
Vilnius, Lithuania, 8661
Principal Investigator: Rasa Kizlaitiene         
Zuyderland Recruiting
Sittard-Geleen, Netherlands, 6131 BG
Principal Investigator: Raymond Hupperts         
M.A. - LEK A.M.Maciejowscy SC. Recruiting
Katowice, Poland, 40-571
Principal Investigator: Maciej Maciejowski         
Centrum Medyczne Medyk Recruiting
Lublin, Poland, 20-954
Principal Investigator: Halina Bartosik Psujek         
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak Recruiting
Lublin, Poland, 20-954
Principal Investigator: Konrad Rejdak         
Centrum Neurologii K. Selmaj Recruiting
Łódź, Poland, 90-153
Principal Investigator: Krzysztof Selmaj         
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany

Responsible Party: Merck KGaA, Darmstadt, Germany 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: October 15, 2018
Last Verified: October 2018

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

Keywords provided by Merck KGaA, Darmstadt, Germany:
Multiple sclerosis
Health-related Quality of Life

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