AzTrials
AzTrials

Multiple SclerosisPhase 4NCT04776213

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

A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 60 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Mavenclad®
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
60 sitesin 10 countries
Study dates
23 Feb 2021to 20 Jun 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

Italy13 sites

  • A.O.U. Ospedali Riuniti Umberto

    Ancona

  • University of Cagliari

    Cagliari

  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania

    Catania

  • Ospedale San Raffaele Giglio

    Cefalù

  • Instituto Nazionale Neurologico "Carlo Besta"

    Milan

  • Ospedale San Raffaele, IRCCS

    Milan

  • A.O. Universitaria Federico II

    Naples

  • Policlinico Università della Campania L. Vanvitelli

    Naples

  • A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog

    Palermo

  • Azienda Ospedaliera S. Camillo Forlanini

    Roma

  • Neurological Center of Latium

    Roma

  • Ospedale Sant'Andrea Neurologia - Università La Sapienza

    Roma

  • Policlinico Tor Vergata

    Roma

Other trials in Italy

France10 sites

  • Centre hospitalier de la Côte Basque - Saint Léon

    Bayonne

  • Pellegrin

    Bordeaux

  • CHU de la Côte de Nacre

    Caen

  • Centre Hospitalier de Gonesse

    Gonesse

  • CHRU de Lille Hôpital Roger Salengro

    Lille

  • CHU Hôpital Nord Laennec

    Nantes

  • Hôpital de la Pitié-Salpétrière

    Paris Cédex 13

  • CHU de Poissy

    Poissy

  • Centre Universitaire de Rouen

    Rouen

  • CHU Tours - Hôpital Bretonneau

    Tours

Other trials in France

Czechia8 sites

  • FN u sv. Anny Brno

    Brno

  • FN Hradec Králové

    Hradec Králové

  • Nemocnice Jihlava, p.o.

    Jihlava

  • Fakultni nemocnice Olomouc

    Olomouc

  • Fakultni nemocnice Ostrava

    Ostrava

  • Faculty Hospital Kralovske Vinohrady

    Prague

  • Vseobecna fakultni nemocnice v Praze

    Prague

  • Nemocnice Teplice

    Teplice

Other trials in Czechia

Spain8 sites

  • Hospital Universitario de Getafe

    Getafe

  • C.A.U. de León - H. de León

    León

  • Hospital Arnau de Vilanova

    Lleida

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Virgen de la Arrixaca

    Murcia

  • Hospital de Sant Joan Despí Moisès Broggi

    Sant Joan Despí

  • Hospital Universitario Nuestra Senora de la Candelaria

    Santa Cruz de Tenerife

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

Other trials in Spain

Poland7 sites

  • COPERNICUS Podmiot Leczn. Sp z o.o.

    Gdansk

  • M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM

    Katowice

  • Centrum Neurologii Krzysztof Selmaj

    Lodz

  • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie

    Lodz

  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

    Lublin

  • Centrum Medyczne Medyk

    Rzeszów

  • Instytut Psychiatrii i Neurologii - Dept of Neurology II

    Warsaw

Other trials in Poland

Hungary6 sites

  • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

    Budapest

  • Semmelweis University II

    Budapest

  • Uzsoki Utcai Korhaz

    Budapest

  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum

    Debrecen

  • Valeomed Kft

    Esztergom

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór

    Nyíregyháza

Other trials in Hungary

Slovakia4 sites

  • Neuropoint s.r.o

    Bratislava

  • Univerzitna nemocnica Martin

    Martin

  • Fakultna nemocnica Nitra

    Nitra

  • Fakultna nemocnica Trnava

    Trnava

Other trials in Slovakia

Denmark2 sites

  • Glostrup Sygehus

    Glostrup Municipality

  • Odense Univeristy Hospital

    Odense

Other trials in Denmark

Austria1 site

  • Eva Maida

    Vienna

Other trials in Austria

Netherlands1 site

  • Zuyderland

    Sittard-Geleen

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Mavenclad®
Keywords
Multiple sclerosis, Health related quality of life, Mavenclad®, Relapsing Multiple Sclerosis, Cladribine, Cognitive impairment cognition, Fatigue
Medical subject headings
Multiple Sclerosis, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mavenclad®Drug

    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®.

Study groups in NCT04776213
Study groupRoleWhat they receive
Mavenclad®ExperimentalNot described
Receives: Drug: Mavenclad®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    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.

    Measured: Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)

Secondary outcomes (2)

  1. 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

    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.

    Measured: Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

  2. 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

    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.

    Measured: Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2021
  2. Study start23 Feb 2021
  3. Primary completion20 Jun 2023
  4. Study completion20 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04776213
Sponsor's protocol ID
MS700568_0158
Other IDs
2020-003874-30
Status last verified
May 2024
First submitted
26 Feb 2021
Last updated
28 May 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Lechner-Scott J, Langdon D, Brochet B, Solari A, Havrdova EK, Patti F, Smyk A, Danten M, Nolting A, Montalban X, Selmaj K; CLARIFY-MS Extension Study investigators. Cognitive resilience and improvements in health-related quality of life over 4 years in people with relapsing multiple sclerosis treated with cladribine tablets: Results from the CLARIFY-MS Extension study. Mult Scler Relat Disord. 2026 Sep 20;116:107929. doi: 10.1016/j.msard.2026.107929. Online ahead of print.

    PubMed 42966339

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mavenclad® in people with Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Italy, France, Czechia, Spain, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04776213, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in