Clinical trial NCT03369665: Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
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® (CLARIFY MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Mavenclad®
Cladribine
Health-related Quality of Life
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Month 24
Secondary outcomes:
measure: Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
timeFrame: At Month 6
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg
city: Wien
country: Austria
facility: Eva Maida
city: Brussels
country: Belgium
facility: Cliniques Univ. St.-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Ottignies
country: Belgium
facility: Clinique Saint Pierre
city: Brno
country: Czechia
facility: FN u sv. Anny Brno
city: Chocen
country: Czechia
facility: FN Hradec Kralove
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, p.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava (11573)
city: Praha 10
country: Czechia
facility: Faculty Hospital Kralovske Vinohrad
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze (11163)
city: Teplice
country: Czechia
facility: Nemocnice Teplice
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
city: Odense
country: Denmark
facility: Odense Univeristy Hospital
city: Sønderborg
country: Denmark
facility: Matthias Kant
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Mikkeli
country: Finland
facility: Terveystalo Mikkeli
city: Turku
country: Finland
facility: Neo Research, Neuro NEO Oy
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque - Saint Léon
city: Bordeaux Cedex
country: France
facility: Hopital Pellegrin
city: Caen
country: France
facility: University Hospital of Caen
city: Lille
country: France
facility: CHRU de Lille
city: Lomme
country: France
facility: Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
city: Nantes Cedex 01
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Centre Hospitalier de Gonesse
city: Paris
country: France
facility: Hôpital de la Pitié-Salpétrière
city: Poissy Cedex
country: France
facility: CHU de Poissy
city: Puy-de-Dome
country: France
facility: CHU Hopital Gabriel Montpied
city: Rouen
country: France
facility: Centre Universitaire de Rouen
city: Toulouse
country: France
facility: Hopital Pierre-Paul Riquet - Neurologie
city: Tours Cedex
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Athens
country: Greece
facility: Hos. Errikos Dynan
city: Athens
country: Greece
facility: 401 Army Hospital
city: Athens
country: Greece
facility: Athens Medical Centre
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
city: Debrecen
country: Hungary
facility: University of Debrecen
city: Esztergom
country: Hungary
facility: VALEOMED Kft
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto I
city: Cagliari
country: Italy
facility: Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
city: Catania
country: Italy
facility: Policlinico di Catania
city: Cefalù
country: Italy
facility: Ospedale San Raffaele Giglio
city: Milano
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Milano
country: Italy
facility: Instituto Nazionale Neurologico "Carlo Besta"
city: Napoli
country: Italy
facility: A.O. Universitaria Federico II
city: Napoli
country: Italy
facility: Seconda Univesità degli Studi di Napoli, AOU
city: Palermo
country: Italy
facility: Villa Sofia Hospital
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Camillo Forlanini (8025)
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea Università La Sapienza
city: Roma
country: Italy
facility: Neurological Center Of Latium
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas
city: Kaunas
country: Lithuania
facility: Klaipedos Ligonine
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Clinics
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland
city: Drammen
country: Norway
facility: Drammen Hospital
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczn. Sp z o.o.
city: Katowice
country: Poland
facility: M.A. - LEK A.M.Maciejowscy SC.
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
city: Lublin
country: Poland
facility: Centrum Medyczne Medyk
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Łódź
country: Poland
facility: Centrum Neurologii K. Selmaj
city: Braga
country: Portugal
facility: Hospital de Braga
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto E.P.E. Hospital de Santo António
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: León
country: Spain
facility: C.A.U. de León - H. de León
city: Lérida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón (5030)
city: Madrid
country: Spain
facility: H. U. Quirónsalud Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de Getafe
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
city: Santa Cruz De Tenerfie
country: Spain
facility: Hospital Universitario Nuestra Senora de la Candelaria (4776)
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - Servicio de Oncologia
city: Karlstad
country: Sweden
facility: Karlstad Hospital (8232)
city: Motala
country: Sweden
facility: Motala Hospital (11119)
city: Glasgow
country: United Kingdom
facility: Institute of Neurological Sciences
city: Glasgow
country: United Kingdom
facility: Institute of Neurological Sciences
city: Manchester
country: United Kingdom
facility: GM LCRN - Great Manchester Local Clinical Research Network
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Hospitals NHS Foundation Trust
city: Swansea West Glamorgan
country: United Kingdom
facility: Morriston Hospital (4232)
Study officials:
affiliation: Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: