Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
- Registration Number
- NCT03369665
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mavenclad® Mavenclad® -
- Primary Outcome Measures
Name Time Method 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 Baseline, 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.
- Secondary Outcome Measures
Name Time Method Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6 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.
Trial Locations
- Locations (90)
Clinique Saint Pierre
🇧🇪Ottignies, Belgium
Athens Medical Centre
🇬🇷Athens, Greece
Semmelweis Egyetem AOK
🇭🇺Budapest, Hungary
Glostrup University Hospital
🇩🇰Glostrup, Denmark
Instituto Nazionale Neurologico "Carlo Besta"
🇮🇹Milano, Italy
Policlinico di Catania
🇮🇹Catania, Italy
Ospedale San Raffaele, IRCCS
🇮🇹Milano, Italy
Azienda Ospedaliera S. Camillo Forlanini (8025)
🇮🇹Roma, Italy
Azienda Ospedaliera Sant'Andrea Università La Sapienza
🇮🇹Roma, Italy
Paracelsus Medical University Salzburg
🇦🇹Salzburg, Austria
Eva Maida
🇦🇹Wien, Austria
Cliniques Univ. St.-Luc
🇧🇪Brussels, Belgium
Kepler Universitätsklinikum
🇦🇹Linz, Austria
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Fakultni nemocnice Ostrava (11573)
🇨🇿Ostrava, Czechia
Faculty Hospital Kralovske Vinohrad
🇨🇿Praha 10, Czechia
Aalborg Hospital
🇩🇰Aalborg, Denmark
Nemocnice Teplice
🇨🇿Teplice, Czechia
Odense Univeristy Hospital
🇩🇰Odense, Denmark
Centre hospitalier de la Côte Basque - Saint Léon
🇫🇷Bayonne, France
Hopital Pellegrin
🇫🇷Bordeaux Cedex, France
Matthias Kant
🇩🇰Sønderborg, Denmark
CHU de Nantes
🇫🇷Nantes Cedex 01, France
Centre Hospitalier de Gonesse
🇫🇷Paris, France
Hôpital de la Pitié-Salpétrière
🇫🇷Paris, France
Centre Universitaire de Rouen
🇫🇷Rouen, France
Hopital Pierre-Paul Riquet - Neurologie
🇫🇷Toulouse, France
CHU Tours - Hôpital Bretonneau
🇫🇷Tours Cedex, France
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
University of Debrecen
🇭🇺Debrecen, Hungary
VALEOMED Kft
🇭🇺Esztergom, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
🇭🇺Nyiregyhaza, Hungary
Ospedale San Raffaele Giglio
🇮🇹Cefalù, Italy
A.O.U. Ospedali Riuniti Umberto I
🇮🇹Ancona, Italy
Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
🇮🇹Cagliari, Italy
Seconda Univesità degli Studi di Napoli, AOU
🇮🇹Napoli, Italy
Centrum Neurologii K. Selmaj
🇵🇱Łódź, Poland
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
C.A.U. de León - H. de León
🇪🇸León, Spain
Vseobecna fakultni nemocnice v Praze (11163)
🇨🇿Praha 2, Czechia
FN Hradec Kralove
🇨🇿Chocen, Czechia
Nemocnice Jihlava, p.o.
🇨🇿Jihlava, Czechia
UZ Antwerpen
🇧🇪Edegem, Belgium
FN u sv. Anny Brno
🇨🇿Brno, Czechia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
CHRU de Lille
🇫🇷Lille, France
CHU de Poissy
🇫🇷Poissy Cedex, France
University Hospital of Caen
🇫🇷Caen, France
Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
🇫🇷Lomme, France
CHU Hopital Gabriel Montpied
🇫🇷Puy-de-Dome, France
Hos. Errikos Dynan
🇬🇷Athens, Greece
401 Army Hospital
🇬🇷Athens, Greece
Villa Sofia Hospital
🇮🇹Palermo, Italy
A.O. Universitaria Federico II
🇮🇹Napoli, Italy
Neurological Center Of Latium
🇮🇹Roma, Italy
Hospital of Lithuanian University of Health Sciences Kaunas
🇱🇹Kaunas, Lithuania
Klaipedos Ligonine
🇱🇹Kaunas, Lithuania
Vilnius University Hospital Santariskiu Clinics
🇱🇹Vilnius, Lithuania
Policlinico Tor Vergata
🇮🇹Roma, Italy
M.A. - LEK A.M.Maciejowscy SC.
🇵🇱Katowice, Poland
Centrum Medyczne Medyk
🇵🇱Lublin, Poland
Drammen Hospital
🇳🇴Drammen, Norway
Instytut Psychiatrii i Neurologii
🇵🇱Warszawa, Poland
COPERNICUS Podmiot Leczn. Sp z o.o.
🇵🇱Gdansk, Poland
Zuyderland
🇳🇱Sittard-Geleen, Netherlands
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
🇵🇱Lodz, Poland
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
🇵🇱Lublin, Poland
Hospital de Braga
🇵🇹Braga, Portugal
Centro Hospitalar do Porto E.P.E. Hospital de Santo António
🇵🇹Porto, Portugal
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Hospital Arnau de Vilanova
🇪🇸Lérida, Spain
Hospital General Universitario Gregorio Marañón (5030)
🇪🇸Madrid, Spain
H. U. Quirónsalud Madrid
🇪🇸Madrid, Spain
Hospital Universitario Nuestra Senora de la Candelaria (4776)
🇪🇸Santa Cruz De Tenerfie, Spain
Hospital de Sant Joan Despí Moisès Broggi
🇪🇸Sant Joan Despí, Spain
Hospital Universitario de Getafe
🇪🇸Madrid, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
🇪🇸Sevilla, Spain
Karlstad Hospital (8232)
🇸🇪Karlstad, Sweden
Motala Hospital (11119)
🇸🇪Motala, Sweden
GM LCRN - Great Manchester Local Clinical Research Network
🇬🇧Manchester, United Kingdom
Morriston Hospital (4232)
🇬🇧Swansea West Glamorgan, United Kingdom
Institute of Neurological Sciences
🇬🇧Glasgow, United Kingdom
The Newcastle Hospitals NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, United Kingdom
Terveystalo Mikkeli
🇫🇮Mikkeli, Finland
Neo Research, Neuro NEO Oy
🇫🇮Turku, Finland
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
🇭🇺Budapest, Hungary