Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)
NCT ID: NCT04776213
Last Updated: 2024-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
280 participants
INTERVENTIONAL
2021-02-23
2023-06-20
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
OTHER
NONE
Study Groups
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Mavenclad®
Mavenclad®
This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.
Interventions
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Mavenclad®
This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.
Eligibility Criteria
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Inclusion Criteria
* Received at least a single dose of cladribine tablets in the CLARIFY MS study
* Completed the Final Study Visit (M24) of the CLARIFY MS study
* Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
Exclusion Criteria
* Participation in other studies.
18 Years
ALL
No
Sponsors
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Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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Eva Maida
Vienna, , Austria
FN u sv. Anny Brno
Brno, , Czechia
FN Hradec Králové
Hradec Králové, , Czechia
Nemocnice Jihlava, p.o.
Jihlava, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Faculty Hospital Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Nemocnice Teplice
Teplice, , Czechia
Glostrup Sygehus
Glostrup Municipality, , Denmark
Odense Univeristy Hospital
Odense, , Denmark
Centre hospitalier de la Côte Basque - Saint Léon
Bayonne, , France
Pellegrin
Bordeaux, , France
CHU de la Côte de Nacre
Caen, , France
Centre Hospitalier de Gonesse
Gonesse, , France
CHRU de Lille Hôpital Roger Salengro
Lille, , France
CHU Hôpital Nord Laennec
Nantes, , France
Hôpital de la Pitié-Salpétrière
Paris Cédex 13, , France
CHU de Poissy
Poissy, , France
Centre Universitaire de Rouen
Rouen, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, , Hungary
Semmelweis University II
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
Debrecen, , Hungary
Valeomed Kft
Esztergom, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, , Hungary
A.O.U. Ospedali Riuniti Umberto
Ancona, , Italy
University of Cagliari
Cagliari, , Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania, , Italy
Ospedale San Raffaele Giglio
Cefalù, , Italy
Instituto Nazionale Neurologico "Carlo Besta"
Milan, , Italy
Ospedale San Raffaele, IRCCS
Milan, , Italy
A.O. Universitaria Federico II
Napoli, , Italy
Policlinico Università della Campania L. Vanvitelli
Napoli, , Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
Palermo, , Italy
Azienda Ospedaliera S. Camillo Forlanini
Roma, , Italy
Neurological Center of Latium
Roma, , Italy
Ospedale Sant'Andrea Neurologia - Università La Sapienza
Roma, , Italy
Policlinico Tor Vergata
Roma, , Italy
Zuyderland
Sittard-Geleen, , Netherlands
COPERNICUS Podmiot Leczn. Sp z o.o.
Gdansk, , Poland
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
Katowice, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
Lodz, , Poland
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
Instytut Psychiatrii i Neurologii - Dept of Neurology II
Warsaw, , Poland
Neuropoint s.r.o
Bratislava, , Slovakia
Univerzitna nemocnica Martin
Martin, , Slovakia
Fakultna nemocnica Nitra
Nitra, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Hospital Universitario de Getafe
Getafe, , Spain
C.A.U. de León - H. de León
León, , Spain
Hospital Arnau de Vilanova
Lleida, , Spain
Hospital General Universitario Gregorio Marañón
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
Santa Cruz de Tenerife, , Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, , Spain
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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2020-003874-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MS700568_0158
Identifier Type: -
Identifier Source: org_study_id
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