Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
NCT ID: NCT03369665
Last Updated: 2023-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
485 participants
INTERVENTIONAL
2018-06-20
2021-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mavenclad®
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Kepler Universitätsklinikum
Linz, , Austria
Paracelsus Medical University Salzburg
Salzburg, , Austria
Eva Maida
Vienna, , Austria
Cliniques Univ. St.-Luc
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
FN u sv. Anny Brno
Brno, , Czechia
FN Hradec Kralove
Choceň, , Czechia
Nemocnice Jihlava, p.o.
Jihlava, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava (11573)
Ostrava, , Czechia
Faculty Hospital Kralovske Vinohrad
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze (11163)
Prague, , Czechia
Nemocnice Teplice
Teplice, , Czechia
Aalborg Hospital
Aalborg, , Denmark
Glostrup University Hospital
Glostrup Municipality, , Denmark
Odense Univeristy Hospital
Odense, , Denmark
Matthias Kant
Sønderborg, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Helsinki University Central Hospital
Helsinki, , Finland
Terveystalo Mikkeli
Mikkeli, , Finland
Neo Research, Neuro NEO Oy
Turku, , Finland
Centre hospitalier de la Côte Basque - Saint Léon
Bayonne, , France
Hopital Pellegrin
Bordeaux, , France
University Hospital of Caen
Caen, , France
CHRU de Lille
Lille, , France
Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
Lomme, , France
CHU de Nantes
Nantes, , France
Centre Hospitalier de Gonesse
Paris, , France
Hôpital de la Pitié-Salpétrière
Paris, , France
CHU de Poissy
Poissy, , France
CHU Hopital Gabriel Montpied
Puy-de-Dome, , France
Centre Universitaire de Rouen
Rouen, , France
Hopital Pierre-Paul Riquet - Neurologie
Toulouse, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Hos. Errikos Dynan
Athens, , Greece
401 Army Hospital
Athens, , Greece
Athens Medical Centre
Athens, , Greece
Semmelweis Egyetem AOK
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, , Hungary
University of Debrecen
Debrecen, , Hungary
VALEOMED Kft
Esztergom, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, , Hungary
A.O.U. Ospedali Riuniti Umberto I
Ancona, , Italy
Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
Cagliari, , Italy
Policlinico di Catania
Catania, , Italy
Ospedale San Raffaele Giglio
Cefalù, , Italy
Ospedale San Raffaele, IRCCS
Milan, , Italy
Instituto Nazionale Neurologico "Carlo Besta"
Milan, , Italy
A.O. Universitaria Federico II
Napoli, , Italy
Seconda Univesità degli Studi di Napoli, AOU
Napoli, , Italy
Villa Sofia Hospital
Palermo, , Italy
Azienda Ospedaliera S. Camillo Forlanini (8025)
Roma, , Italy
Azienda Ospedaliera Sant'Andrea Università La Sapienza
Roma, , Italy
Neurological Center Of Latium
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, , Lithuania
Klaipedos Ligonine
Kaunas, , Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, , Lithuania
Zuyderland
Sittard-Geleen, , Netherlands
Drammen Hospital
Drammen, , Norway
COPERNICUS Podmiot Leczn. Sp z o.o.
Gdansk, , Poland
M.A. - LEK A.M.Maciejowscy SC.
Katowice, , Poland
Centrum Neurologii K. Selmaj
Lodz, , Poland
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
Lodz, , Poland
Centrum Medyczne Medyk
Lublin, , Poland
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar do Porto E.P.E. Hospital de Santo António
Porto, , Portugal
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Univerzitna nemocnica Martin
Martin, , Slovakia
Fakultna nemocnica Nitra
Nitra, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
C.A.U. de León - H. de León
León, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañón (5030)
Madrid, , Spain
H. U. Quirónsalud Madrid
Madrid, , Spain
Hospital Universitario de Getafe
Madrid, , Spain
Hospital Virgen de la Arrixaca
Murcia, , Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, , Spain
Hospital Universitario Nuestra Senora de la Candelaria (4776)
Santa Cruz de Tenerfie, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Seville, , Spain
Karlstad Hospital (8232)
Karlstad, , Sweden
Motala Hospital (11119)
Motala, , Sweden
Institute of Neurological Sciences
Glasgow, , United Kingdom
Institute of Neurological Sciences
Glasgow, , United Kingdom
GM LCRN - Great Manchester Local Clinical Research Network
Manchester, , United Kingdom
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Morriston Hospital (4232)
Swansea West Glamorgan, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
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2017-002632-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS700568_0021
Identifier Type: -
Identifier Source: org_study_id
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