Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)

Multiple Sclerosis Clinical Trial

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)

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
• 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
• 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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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

External Links

•   Trial Awareness and Transparency website