Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

May 6, 2024 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • 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
      • Vienna, Austria
        • Eva Maida
  • Czechia
      • Brno, Czechia
        • FN u sv. Anny Brno
      • Hradec Kralove, Czechia
        • FN Hradec Králové
      • Jihlava, Czechia
        • Nemocnice Jihlava, p.o.
      • Olomouc, Czechia
        • Fakultni Nemocnice Olomouc
      • Ostrava, Czechia
        • Fakultni Nemocnice Ostrava
      • Praha 10, Czechia
        • Faculty Hospital Královské Vinohrady
      • Praha 2, Czechia
        • Vseobecna Fakultni Nemocnice V Praze
      • Teplice, Czechia
        • Nemocnice Teplice
  • Denmark
      • Glostrup, Denmark
        • Glostrup Sygehus
      • Odense, Denmark
        • odense univeristy hospital
  • France
      • Bayonne, France
        • Centre hospitalier de la Côte Basque - Saint Léon
      • Bordeaux, France
        • Pellegrin
      • Caen, France
        • CHU de la Côte de Nacre
      • Gonesse, France
        • Centre Hospitalier de Gonesse
      • Lille, France
        • CHRU de Lille Hopital Roger Salengro
      • Nantes Cedex 01, France
        • CHU hôpital Nord Laennec
      • Paris Cédex 13, France
        • Hôpital de la Pitié-Salpêtrière
      • Poissy Cedex, France
        • CHU de Poissy
      • Rouen Cedex, France
        • Centre Universitaire de Rouen
      • Tours Cedex, France
        • CHU Tours - Hôpital Bretonneau
  • Hungary
      • Budapest, Hungary
        • Uzsoki Utcai Kórház
      • Budapest, Hungary
        • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
      • Budapest, Hungary
        • Semmelweis University II
      • Debrecen, Hungary
        • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum
      • Esztergom, Hungary
        • Valeomed Kft
      • Nyíregyháza, Hungary
        • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • Italy
      • Ancona, Italy
        • A.O.U. Ospedali Riuniti Umberto
      • Cagliari, Italy
        • University of Cagliari
      • Catania, Italy
        • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
      • Cefalù, Italy
        • Ospedale San Raffaele Giglio
      • Milano, Italy
        • Instituto Nazionale Neurologico "Carlo Besta"
      • Milano, Italy
        • Ospedale San Raffaele, IRCCS
      • Napoli, Italy
        • A.O. Universitaria Federico II
      • Napoli, Italy
        • Policlinico Università della Campania L. Vanvitelli
      • Palermo, Italy
        • A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
      • Roma, Italy
        • Policlinico Tor Vergata
      • Roma, Italy
        • Azienda Ospedaliera S. Camillo Forlanini
      • Roma, Italy
        • Neurological Center Of Latium
      • Roma, Italy
        • Ospedale Sant'Andrea Neurologia - Università La Sapienza
  • Netherlands
      • Sittard-Geleen, Netherlands
        • Zuyderland
  • Poland
      • Gdansk, Poland
        • COPERNICUS Podmiot Leczn. Sp z o.o.
      • Katowice, Poland
        • M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
      • Lodz, Poland
        • Centrum Neurologii Krzysztof Selmaj
      • Lodz, Poland
        • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
      • Lublin, Poland
        • Indywidualna Praktyka Lekarska prof. Konrad Rejdak
      • Rzeszow, Poland
        • Centrum Medyczne Medyk
      • Warszawa, Poland
        • Instytut Psychiatrii i Neurologii - Dept of Neurology II
  • Slovakia
      • Bratislava, Slovakia
        • Neuropoint s.r.o
      • Martin, Slovakia
        • Univerzitna nemocnica MARTIN
      • Nitra, Slovakia
        • Fakultna nemocnica Nitra
      • Trnava, Slovakia
        • Fakultna nemocnica Trnava
  • Spain
      • Getafe, Spain
        • Hospital Universitario de Getafe
      • León, Spain
        • C.A.U. de León - H. de León
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Murcia, Spain
        • Hospital Virgen de la Arrixaca
      • Sant Joan Despí, Spain
        • Hospital de Sant Joan Despi Moises Broggi
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario Nuestra Señora de la Candelaria
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT)
  • Received at least a single dose of cladribine tablets in the CLARIFY MS study
  • Completed the Final Study Visit (M24) of the CLARIFY MS study
  • Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol

Exclusion Criteria:

  • Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
  • Participation in other studies.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mavenclad®
Drug: Mavenclad®
This low interventional extension study involves the follow up of participants in the parent study. The participants were followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants were not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48
Time Frame: Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)
The SDMT is a test of information processing speed. It consists of 9 abstract symbols. Each symbol is paired with a single digit. The participant is provided with a "key", showing each symbol digit pair. In addition, the participants are shown several rows of the 9 symbols, which are arranged pseudo-randomly, without the digit. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 seconds. The SDMT score ranges from 0 to 110 where higher scores indicated improvement and lower scores indicated worsening.
Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years
Time Frame: Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
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 (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years
Time Frame: Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
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.
Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

Collaborators and Investigators

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

Sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigators

  • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of 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)

February 23, 2021

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 1, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS700568_0158
  • 2020-003874-30 (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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