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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03369665
Other study ID # MS700568_0021
Secondary ID 2017-002632-17
Status Completed
Phase Phase 4
First received
Last updated
Start date June 20, 2018
Est. completion date November 12, 2021

Study information

Verified date November 2022
Source Merck KGaA, Darmstadt, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 485
Est. completion date November 12, 2021
Est. primary completion date November 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Austria Kepler Universitätsklinikum Linz
Austria Paracelsus Medical University Salzburg Salzburg
Austria Eva Maida Wien
Belgium Cliniques Univ. St.-Luc Brussels
Belgium UZ Antwerpen Edegem
Belgium Clinique Saint Pierre Ottignies
Czechia FN u sv. Anny Brno Brno
Czechia FN Hradec Kralove Chocen
Czechia Nemocnice Jihlava, p.o. Jihlava
Czechia Fakultni nemocnice Olomouc Olomouc
Czechia Fakultni nemocnice Ostrava (11573) Ostrava
Czechia Faculty Hospital Kralovske Vinohrad Praha 10
Czechia Vseobecna fakultni nemocnice v Praze (11163) Praha 2
Czechia Nemocnice Teplice Teplice
Denmark Aalborg Hospital Aalborg
Denmark Glostrup University Hospital Glostrup
Denmark Odense Univeristy Hospital Odense
Denmark Matthias Kant Sønderborg
Finland Helsinki University Central Hospital Helsinki
Finland Helsinki University Central Hospital Helsinki
Finland Terveystalo Mikkeli Mikkeli
Finland Neo Research, Neuro NEO Oy Turku
France Centre hospitalier de la Côte Basque - Saint Léon Bayonne
France Hopital Pellegrin Bordeaux Cedex
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 Cedex 01
France Centre Hospitalier de Gonesse Paris
France Hôpital de la Pitié-Salpétrière Paris
France CHU de Poissy Poissy Cedex
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 Cedex
Greece 401 Army Hospital Athens
Greece Athens Medical Centre Athens
Greece Hos. Errikos Dynan Athens
Hungary Jahn Ferenc Dél-Pesti Kórház és Rendelointézet Budapest
Hungary Semmelweis Egyetem AOK Budapest
Hungary Uzsoki Utcai Korhaz Budapest
Hungary University of Debrecen Debrecen
Hungary VALEOMED Kft Esztergom
Hungary Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór Nyiregyhaza
Italy 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 Instituto Nazionale Neurologico "Carlo Besta" Milano
Italy Ospedale San Raffaele, IRCCS Milano
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
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Kaunas
Lithuania Klaipedos Ligonine Kaunas
Lithuania Vilnius University Hospital Santariskiu Clinics Vilnius
Netherlands Zuyderland Sittard-Geleen
Norway Drammen Hospital Drammen
Poland COPERNICUS Podmiot Leczn. Sp z o.o. Gdansk
Poland M.A. - LEK A.M.Maciejowscy SC. Katowice
Poland Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie Lodz
Poland Centrum Neurologii K. Selmaj Lódz
Poland Centrum Medyczne Medyk Lublin
Poland Indywidualna Praktyka Lekarska Prof. Konrad Rejdak Lublin
Poland Instytut Psychiatrii i Neurologii Warszawa
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar do Porto E.P.E. Hospital de Santo António Porto
Slovakia Univerzitna nemocnica Bratislava Bratislava
Slovakia Univerzitna nemocnica Martin Martin
Slovakia Fakultna nemocnica Nitra Nitra
Slovakia Fakultna nemocnica Trnava Trnava
Spain C.A.U. de León - H. de León León
Spain Hospital Arnau de Vilanova Lérida
Spain H. U. Quirónsalud Madrid Madrid
Spain Hospital General Universitario Gregorio Marañón (5030) 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 Sevilla
Sweden Karlstad Hospital (8232) Karlstad
Sweden Motala Hospital (11119) Motala
United Kingdom 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

Sponsors (1)

Lead Sponsor Collaborator
Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Finland,  France,  Greece,  Hungary,  Italy,  Lithuania,  Netherlands,  Norway,  Poland,  Portugal,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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