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

November 9, 2022 updated by: Merck KGaA, Darmstadt, Germany

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
485

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4021
        • Kepler Universitätsklinikum
      • Salzburg, Austria
        • Paracelsus Medical University Salzburg
      • Wien, Austria
        • Eva Maida
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Univ. St.-Luc
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Ottignies, Belgium, 1340
        • Clinique Saint Pierre
  • Czechia
      • Brno, Czechia, 65691
        • FN u sv. Anny Brno
      • Chocen, Czechia, 56501
        • FN Hradec Králové
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava, p.o.
      • Olomouc, Czechia, 779 00
        • Fakultni nemocnice Olomouc
      • Ostrava, Czechia, 70852
        • Fakultni nemocnice Ostrava (11573)
      • Praha 10, Czechia, 100 34
        • Faculty Hospital Kralovske Vinohrad
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze (11163)
      • Teplice, Czechia, 415 29
        • Nemocnice Teplice
  • Denmark
      • Aalborg, Denmark, 9100
        • Aalborg Hospital
      • Glostrup, Denmark, DK-2600
        • Glostrup University Hospital
      • Odense, Denmark
        • odense univeristy hospital
      • Sønderborg, Denmark, 6400
        • Matthias Kant
  • Finland
      • Helsinki, Finland
        • Helsinki University Central Hospital
      • Helsinki, Finland, 290
        • Helsinki University Central Hospital
      • Mikkeli, Finland, 50100
        • Terveystalo Mikkeli
      • Turku, Finland
        • Neo Research, Neuro NEO Oy
  • France
      • Bayonne, France, 64100
        • Centre hospitalier de la Côte Basque - Saint Léon
      • Bordeaux Cedex, France, 33076
        • Hôpital Pellegrin
      • Caen, France, 14033
        • University hospital of Caen
      • Lille, France, 59037
        • Chru de Lille
      • Lomme, France
        • Groupe Hospitalier de l'Institut Catholique de Lille - Centre Hospitalier Saint Philibert
      • Nantes Cedex 01, France, 44093
        • Chu de Nantes
      • Paris, France, 75013
        • Hôpital de la Pitié-Salpêtrière
      • Paris, France, 75013
        • Centre Hospitalier de Gonesse
      • Poissy Cedex, France, 78303
        • CHU de Poissy
      • Puy-de-Dome, France, 63003
        • CHU Hopital Gabriel Montpied
      • Rouen, France, 76031
        • Centre Universitaire de Rouen
      • Toulouse, France, 31059
        • Hopital Pierre-Paul Riquet - Neurologie
      • Tours Cedex, France, 37044
        • CHU Tours - Hôpital Bretonneau
  • Greece
      • Athens, Greece, 11526
        • Hos. Errikos Dynan
      • Athens, Greece, 11527
        • 401 Army Hospital
      • Athens, Greece, 11527
        • Athens Medical Centre
  • Hungary
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem AOK
      • Debrecen, Hungary, 4032
        • University of Debrecen
      • Esztergom, Hungary, 2500
        • Valeomed Kft
      • Nyiregyhaza, Hungary, 4403
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • Italy
      • Ancona, Italy
        • A.O.U. Ospedali Riuniti Umberto I
      • Cagliari, Italy, 09126
        • Ospedale Binaghi, Università di Cagliari,ASL 8 - Centro Sclerosi Multipla
      • Catania, Italy, 95125
        • Policlinico di Catania
      • Cefalù, Italy, 90015
        • Ospedale San Raffaele Giglio
      • Milano, Italy, 20127
        • Ospedale San Raffaele, IRCCS
      • Milano, Italy, 20133
        • Instituto Nazionale Neurologico "Carlo Besta"
      • Napoli, Italy, 80131
        • A.O. Universitaria Federico II
      • Napoli, Italy
        • Seconda Univesità degli Studi di Napoli, AOU
      • Palermo, Italy, 90146
        • Villa Sofia Hospital
      • Roma, Italy
        • Policlinico Tor Vergata
      • Roma, Italy, 00152
        • Azienda Ospedaliera S. Camillo Forlanini (8025)
      • Roma, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea Università La Sapienza
      • Roma, Italy, 00189
        • Neurological Center Of Latium
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Kaunas, Lithuania, 50161
        • Klaipedos Ligonine
      • Vilnius, Lithuania, 8661
        • Vilnius University Hospital Santariskiu Clinics
  • Netherlands
      • Sittard-Geleen, Netherlands, 6131 BG
        • Zuyderland
  • Norway
      • Drammen, Norway, 3004
        • Drammen Hospital
  • Poland
      • Gdansk, Poland, 80-803
        • COPERNICUS Podmiot Leczn. Sp z o.o.
      • Katowice, Poland, 40-571
        • M.A. - LEK A.M.Maciejowscy SC.
      • Lodz, Poland, 90-153
        • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
      • Lublin, Poland, 20-954
        • Centrum Medyczne Medyk
      • Lublin, Poland, 20-954
        • Indywidualna Praktyka Lekarska prof. Konrad Rejdak
      • Warszawa, Poland, 02-957
        • Instytut Psychiatrii i Neurologii
      • Łódź, Poland, 90-153
        • Centrum Neurologii K. Selmaj
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto E.P.E. Hospital de Santo António
  • Slovakia
      • Bratislava, Slovakia, 813 69
        • Univerzitna nemocnica Bratislava
      • Martin, Slovakia, 036 01
        • Univerzitna nemocnica MARTIN
      • Nitra, Slovakia, 950 01
        • Fakultna nemocnica Nitra
      • Trnava, Slovakia, 917 75
        • Fakultna nemocnica Trnava
  • Spain
      • León, Spain, 24071
        • C.A.U. de León - H. de León
      • Lérida, Spain, 25198
        • Hospital Arnau de Vilanova
      • Madrid, Spain, 28905
        • Hospital Universitario de Getafe
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón (5030)
      • Madrid, Spain, 28040
        • H. U. Quirónsalud Madrid
      • Murcia, Spain, 30120
        • Hospital Virgen de la Arrixaca
      • Sant Joan Despí, Spain, 08970
        • Hospital de Sant Joan Despi Moises Broggi
      • Santa Cruz De Tenerfie, Spain, 38010
        • Hospital Universitario Nuestra Senora de la Candelaria (4776)
      • Santiago de Compostela, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio - Servicio de Oncologia
  • Sweden
      • Karlstad, Sweden, 651 86
        • Karlstad Hospital (8232)
      • Motala, Sweden, 59185
        • Motala Hospital (11119)
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Institute of Neurological Sciences
      • Glasgow, United Kingdom
        • Institute of Neurological Sciences
      • Manchester, United Kingdom, M13 9WL
        • GM LCRN - Great Manchester Local Clinical Research Network
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • The Newcastle Hospitals NHS Foundation Trust
      • Swansea West Glamorgan, United Kingdom, SA6 6NL
        • Morriston Hospital (4232)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mavenclad®
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.
Other Names:
  • Cladribine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Baseline, Month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment Global Satisfaction Determined by Treatment Satisfaction Questionnaire Medication Version 1.4 (TSQM v1.4) Scale at Month 6
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Responsible, Merck KGaA, Darmstadt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS700568_0021
  • 2017-002632-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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