Evaluation of Quality of Life (QoL) in Subjects With Highly Active Relapsing Multiple Sclerosis (MS) (CLARIFY MS)
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)
2 other identifiers
interventional
485
18 countries
92
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 multiple-sclerosis
Started Jun 2018
Typical duration for phase_4 multiple-sclerosis
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 12, 2017
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2021
CompletedResults Posted
Study results publicly available
September 14, 2023
CompletedSeptember 14, 2023
November 1, 2022
3.4 years
December 6, 2017
November 9, 2022
November 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
At Month 6
Study Arms (1)
Mavenclad®
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
Kepler Universitätsklinikum
Linz, 4021, Austria
Paracelsus Medical University Salzburg
Salzburg, Austria
Eva Maida
Vienna, Austria
Cliniques Univ. St.-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
Clinique Saint Pierre
Ottignies, 1340, Belgium
FN u sv. Anny Brno
Brno, 65691, Czechia
FN Hradec Kralove
Choceň, 56501, Czechia
Nemocnice Jihlava, p.o.
Jihlava, 586 33, Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00, Czechia
Fakultni nemocnice Ostrava (11573)
Ostrava, 70852, Czechia
Faculty Hospital Kralovske Vinohrad
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze (11163)
Prague, 128 08, Czechia
Nemocnice Teplice
Teplice, 415 29, Czechia
Aalborg Hospital
Aalborg, 9100, Denmark
Glostrup University Hospital
Glostrup Municipality, DK-2600, Denmark
Odense Univeristy Hospital
Odense, Denmark
Matthias Kant
Sønderborg, 6400, Denmark
Helsinki University Central Hospital
Helsinki, 290, Finland
Helsinki University Central Hospital
Helsinki, Finland
Terveystalo Mikkeli
Mikkeli, 50100, Finland
Neo Research, Neuro NEO Oy
Turku, Finland
Centre hospitalier de la Côte Basque - Saint Léon
Bayonne, 64100, France
Hopital Pellegrin
Bordeaux, 33076, France
University Hospital of Caen
Caen, 14033, France
CHRU de Lille
Lille, 59037, France
Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
Lomme, France
CHU de Nantes
Nantes, 44093, France
Centre Hospitalier de Gonesse
Paris, 75013, France
Hôpital de la Pitié-Salpétrière
Paris, 75013, France
CHU de Poissy
Poissy, 78303, France
CHU Hopital Gabriel Montpied
Puy-de-Dome, 63003, France
Centre Universitaire de Rouen
Rouen, 76031, France
Hopital Pierre-Paul Riquet - Neurologie
Toulouse, 31059, France
CHU Tours - Hôpital Bretonneau
Tours, 37044, France
Hos. Errikos Dynan
Athens, 11526, Greece
401 Army Hospital
Athens, 11527, Greece
Athens Medical Centre
Athens, 11527, Greece
Semmelweis Egyetem AOK
Budapest, 1083, Hungary
Uzsoki Utcai Korhaz
Budapest, 1145, Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
Budapest, 1204, Hungary
University of Debrecen
Debrecen, 4032, Hungary
VALEOMED Kft
Esztergom, 2500, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
Nyíregyháza, 4403, Hungary
A.O.U. Ospedali Riuniti Umberto I
Ancona, Italy
Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
Cagliari, 09126, Italy
Policlinico di Catania
Catania, 95125, Italy
Ospedale San Raffaele Giglio
Cefalù, 90015, Italy
Ospedale San Raffaele, IRCCS
Milan, 20127, Italy
Instituto Nazionale Neurologico "Carlo Besta"
Milan, 20133, Italy
A.O. Universitaria Federico II
Napoli, 80131, Italy
Seconda Univesità degli Studi di Napoli, AOU
Napoli, Italy
Villa Sofia Hospital
Palermo, 90146, Italy
Azienda Ospedaliera S. Camillo Forlanini (8025)
Roma, 00152, Italy
Azienda Ospedaliera Sant'Andrea Università La Sapienza
Roma, 00189, Italy
Neurological Center Of Latium
Roma, 00189, Italy
Policlinico Tor Vergata
Roma, Italy
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50161, Lithuania
Klaipedos Ligonine
Kaunas, 50161, Lithuania
Vilnius University Hospital Santariskiu Clinics
Vilnius, 8661, Lithuania
Zuyderland
Sittard-Geleen, 6131 BG, Netherlands
Drammen Hospital
Drammen, 3004, Norway
COPERNICUS Podmiot Leczn. Sp z o.o.
Gdansk, 80-803, Poland
M.A. - LEK A.M.Maciejowscy SC.
Katowice, 40-571, Poland
Centrum Neurologii K. Selmaj
Lodz, 90-153, Poland
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
Lodz, 90-153, Poland
Centrum Medyczne Medyk
Lublin, 20-954, Poland
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
Lublin, 20-954, Poland
Instytut Psychiatrii i Neurologii
Warsaw, 02-957, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Centro Hospitalar do Porto E.P.E. Hospital de Santo António
Porto, 4099-001, Portugal
Univerzitna nemocnica Bratislava
Bratislava, 813 69, Slovakia
Univerzitna nemocnica Martin
Martin, 036 01, Slovakia
Fakultna nemocnica Nitra
Nitra, 950 01, Slovakia
Fakultna nemocnica Trnava
Trnava, 917 75, Slovakia
C.A.U. de León - H. de León
León, 24071, Spain
Hospital Arnau de Vilanova
Lleida, 25198, Spain
Hospital General Universitario Gregorio Marañón (5030)
Madrid, 28007, Spain
H. U. Quirónsalud Madrid
Madrid, 28040, Spain
Hospital Universitario de Getafe
Madrid, 28905, Spain
Hospital Virgen de la Arrixaca
Murcia, 30120, Spain
Hospital de Sant Joan Despí Moisès Broggi
Sant Joan Despí, 08970, Spain
Hospital Universitario Nuestra Senora de la Candelaria (4776)
Santa Cruz de Tenerfie, 38010, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Universitario Virgen del Rocio - Servicio de Oncologia
Seville, 41013, Spain
Karlstad Hospital (8232)
Karlstad, 651 86, Sweden
Motala Hospital (11119)
Motala, 59185, Sweden
Institute of Neurological Sciences
Glasgow, G51 4TF, United Kingdom
Institute of Neurological Sciences
Glasgow, United Kingdom
GM LCRN - Great Manchester Local Clinical Research Network
Manchester, M13 9WL, United Kingdom
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE1 4LP, United Kingdom
Morriston Hospital (4232)
Swansea West Glamorgan, SA6 6NL, United Kingdom
Related Publications (1)
Brochet B, Solari A, Lechner-Scott J, Piehl F, Langdon D, Hupperts R, Selmaj K, Patti F, Brieva L, Maida EM, Alexandri N, Smyk A, Nolting A, Keller B, Montalban X, Kubala Havrdova E. Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study. Mult Scler. 2023 Dec;29(14):1808-1818. doi: 10.1177/13524585231205962. Epub 2023 Nov 18.
PMID: 37978852DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 12, 2017
Study Start
June 20, 2018
Primary Completion
November 12, 2021
Study Completion
November 12, 2021
Last Updated
September 14, 2023
Results First Posted
September 14, 2023
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
- Access Criteria
- Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21