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

A 2-Year Prospective Study to Assess Health-related Quality of Life In Subjects With Highly-Active Relapsing Multiple Sclerosis Treated With Mavenclad® (CLARIFY MS)

The main purpose of the study was 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) particpants treated with Mavenclad® for 2 years (24 months).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Mavenclad®

• Study Type: Interventional
• Enrollment (Actual): 485
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4021
    • Kepler Universitätsklinikum
  • Salzburg, Austria
    • Paracelsus Medical University Salzburg
  • Wien, Austria
    • Eva Maida
• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Univ. St.-Luc
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Ottignies, Belgium, 1340
    • Clinique Saint Pierre
• Czechia
  • Brno, Czechia, 65691
    • FN u sv. Anny Brno
  • Chocen, Czechia, 56501
    • FN Hradec Králové
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava, p.o.
  • Olomouc, Czechia, 779 00
    • Fakultni nemocnice Olomouc
  • Ostrava, Czechia, 70852
    • Fakultni nemocnice Ostrava (11573)
  • Praha 10, Czechia, 100 34
    • Faculty Hospital Kralovske Vinohrad
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze (11163)
  • Teplice, Czechia, 415 29
    • Nemocnice Teplice
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg Hospital
  • Glostrup, Denmark, DK-2600
    • Glostrup University Hospital
  • Odense, Denmark
    • odense univeristy hospital
  • Sønderborg, Denmark, 6400
    • Matthias Kant
• Finland
  • Helsinki, Finland
    • Helsinki University Central Hospital
  • Helsinki, Finland, 290
    • Helsinki University Central Hospital
  • Mikkeli, Finland, 50100
    • Terveystalo Mikkeli
  • Turku, Finland
    • Neo Research, Neuro NEO Oy
• France
  • Bayonne, France, 64100
    • Centre hospitalier de la Côte Basque - Saint Léon
  • Bordeaux Cedex, France, 33076
    • Hôpital Pellegrin
  • Caen, France, 14033
    • University hospital of Caen
  • Lille, France, 59037
    • Chru De Lille
  • Lomme, France
    • Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
  • Nantes Cedex 01, France, 44093
    • CHU de Nantes
  • Paris, France, 75013
    • Hôpital de la Pitié-Salpêtrière
  • Paris, France, 75013
    • Centre Hospitalier de Gonesse
  • Poissy Cedex, France, 78303
    • CHU de Poissy
  • Puy-de-Dome, France, 63003
    • CHU Hopital Gabriel Montpied
  • Rouen, France, 76031
    • Centre Universitaire de Rouen
  • Toulouse, France, 31059
    • Hopital Pierre-Paul Riquet - Neurologie
  • Tours Cedex, France, 37044
    • CHU Tours - Hôpital Bretonneau
• Greece
  • Athens, Greece, 11526
    • Hos. Errikos Dynan
  • Athens, Greece, 11527
    • 401 Army Hospital
  • Athens, Greece, 11527
    • Athens Medical Centre
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1145
    • Uzsoki Utcai Kórház
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem AOK
  • Debrecen, Hungary, 4032
    • University of Debrecen
  • Esztergom, Hungary, 2500
    • Valeomed Kft
  • Nyiregyhaza, Hungary, 4403
    • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
• Italy
  • Ancona, Italy
    • A.O.U. Ospedali Riuniti Umberto I
  • Cagliari, Italy, 09126
    • Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
  • Catania, Italy, 95125
    • Policlinico di Catania
  • Cefalù, Italy, 90015
    • Ospedale San Raffaele Giglio
  • Milano, Italy, 20127
    • Ospedale San Raffaele, IRCCS
  • Milano, Italy, 20133
    • Instituto Nazionale Neurologico "Carlo Besta"
  • Napoli, Italy, 80131
    • A.O. Universitaria Federico II
  • Napoli, Italy
    • Seconda Univesità degli Studi di Napoli, AOU
  • Palermo, Italy, 90146
    • Villa Sofia Hospital
  • Roma, Italy
    • Policlinico Tor Vergata
  • Roma, Italy, 00152
    • Azienda Ospedaliera S. Camillo Forlanini (8025)
  • Roma, Italy, 00189
    • Azienda Ospedaliera Sant'Andrea Università La Sapienza
  • Roma, Italy, 00189
    • Neurological Center Of Latium
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas
  • Kaunas, Lithuania, 50161
    • Klaipedos Ligonine
  • Vilnius, Lithuania, 8661
    • Vilnius University Hospital Santariskiu Clinics
• Netherlands
  • Sittard-Geleen, Netherlands, 6131 BG
    • Zuyderland
• Norway
  • Drammen, Norway, 3004
    • Drammen Hospital
• Poland
  • Gdansk, Poland, 80-803
    • COPERNICUS Podmiot Leczn. Sp z o.o.
  • Katowice, Poland, 40-571
    • M.A. - LEK A.M.Maciejowscy SC.
  • Lodz, Poland, 90-153
    • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
  • Lublin, Poland, 20-954
    • Centrum Medyczne Medyk
  • Lublin, Poland, 20-954
    • Indywidualna Praktyka Lekarska prof. Konrad Rejdak
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii
  • Łódź, Poland, 90-153
    • Centrum Neurologii K. Selmaj
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto E.P.E. Hospital de Santo António
• Slovakia
  • Bratislava, Slovakia, 813 69
    • Univerzitna nemocnica Bratislava
  • Martin, Slovakia, 036 01
    • Univerzitna nemocnica MARTIN
  • Nitra, Slovakia, 950 01
    • Fakultna nemocnica Nitra
  • Trnava, Slovakia, 917 75
    • Fakultna Nemocnica Trnava
• Spain
  • León, Spain, 24071
    • C.A.U. de León - H. de León
  • Lérida, Spain, 25198
    • Hospital Arnau de Vilanova
  • Madrid, Spain, 28905
    • Hospital Universitario de Getafe
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón (5030)
  • Madrid, Spain, 28040
    • H. U. Quirónsalud Madrid
  • Murcia, Spain, 30120
    • Hospital Virgen de la Arrixaca
  • Sant Joan Despí, Spain, 08970
    • Hospital de Sant Joan Despi Moises Broggi
  • Santa Cruz De Tenerfie, Spain, 38010
    • Hospital Universitario Nuestra Senora de la Candelaria (4776)
  • Santiago de Compostela, Spain, 15706
    • Complejo Hospitalario Universitario de Santiago
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio - Servicio de Oncologia
• Sweden
  • Karlstad, Sweden, 651 86
    • Karlstad Hospital (8232)
  • Motala, Sweden, 59185
    • Motala Hospital (11119)
• United Kingdom
  • Glasgow, United Kingdom, G51 4TF
    • Institute of Neurological Sciences
  • Glasgow, United Kingdom
    • Institute of Neurological Sciences
  • Manchester, United Kingdom, M13 9WL
    • GM LCRN - Great Manchester Local Clinical Research Network
  • Newcastle Upon Tyne, United Kingdom, NE1 4LP
    • The Newcastle Hospitals NHS Foundation Trust
  • Swansea West Glamorgan, United Kingdom, SA6 6NL
    • Morriston Hospital (4232)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mavenclad®

Drug: Mavenclad®; Participants with Relapsing Multiple Sclerosis (RMS) received 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. Each treatment course consisted of 2 treatment weeks, one at the beginning of the first month and one at the beginning of the second month of the respective year.; Other Names: Cladribine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54) Physical Health Composite Summary and Mental Health Composite Summary Scores at Month 24	The MSQOL-54 was a multidimensional health-related QOL measure that combines both generic and MS-specific items into a single instrument. This 54-item instrument generates 12 sub-scales along with two summary scores, and two additional single-item measures. Sub-scales are: physical function, role limitations-physical, role limitations-emotional, pain, emotional well-being, energy, health perceptions, social function, cognitive function, health distress, overall quality of life, and sexual function. The two summary scores physical health and mental health are derived from a weighted combination of scale scores. Each composite summary score has a range from 0-100 where higher scores indicate better QOL. A positive change from baseline indicates improvement.	Baseline, Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6	TSQM version 1.4 was a global satisfaction scale used to assess the overall level of participant's satisfaction or dissatisfaction with their medications. It comprises of 14 items assessing the following 4 domains: effectiveness (questions: 1-3), side effects (questions: 4-8), convenience (questions: 9-11), global satisfaction (questions:12-14). Global Satisfaction- Question 12 scored as 1 (not at all confident) to 5 (extremely confident); question 13 scored as 1 (not at all certain) to 5 (extremely certain); and question 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). The scores of the domain were added together and an algorithm was used to create a score of 0 to 100. Higher scores indicated greater satisfaction.	At Month 6

Collaborators and Investigators

• Sponsor: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2018
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: December 6, 2017
• First Submitted That Met QC Criteria: December 6, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Multiple sclerosis; Cladribine; Health-related Quality of Life; Mavenclad®
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Cladribine
• Other Study ID Numbers: MS700568_0021; 2017-002632-17 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
• IPD Sharing Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• IPD Sharing Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No