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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Mavenclad®
Sponsored by
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Health related quality of life, Mavenclad®, Relapsing Multiple Sclerosis, Cladribine, Cognitive impairment cognition, Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Eva Maida
  • FN u sv. Anny Brno
  • FN Hradec Králové
  • Nemocnice Jihlava, p.o.
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Ostrava
  • Faculty Hospital Kralovske Vinohrady
  • Vseobecna fakultni nemocnice v Praze
  • Nemocnice Teplice
  • Glostrup Sygehus
  • Odense Univeristy Hospital
  • Centre hospitalier de la Côte Basque - Saint Léon
  • Pellegrin
  • CHU de la Côte de Nacre
  • Centre Hospitalier de Gonesse
  • CHRU de Lille Hôpital Roger Salengro
  • CHU Hôpital Nord Laennec
  • Hôpital de la Pitié-Salpétrière
  • CHU de Poissy
  • Centre Universitaire de Rouen
  • CHU Tours - Hôpital Bretonneau
  • Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
  • Semmelweis University II
  • Uzsoki Utcai Korhaz
  • Debreceni Egyetem Orvos- és Egészségtudományi Centrum
  • Valeomed Kft
  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
  • A.O.U. Ospedali Riuniti Umberto
  • University of Cagliari
  • PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
  • Ospedale San Raffaele Giglio
  • Instituto Nazionale Neurologico "Carlo Besta"
  • Ospedale San Raffaele, IRCCS
  • A.O. Universitaria Federico II
  • Policlinico Università della Campania L. Vanvitelli
  • A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
  • Azienda Ospedaliera S. Camillo Forlanini
  • Neurological Center of Latium
  • Ospedale Sant'Andrea Neurologia - Università La Sapienza
  • Policlinico Tor Vergata
  • Zuyderland
  • COPERNICUS Podmiot Leczn. Sp z o.o.
  • M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
  • Centrum Neurologii Krzysztof Selmaj
  • Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
  • Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
  • Centrum Medyczne Medyk
  • Instytut Psychiatrii i Neurologii - Dept of Neurology II
  • Neuropoint s.r.o
  • Univerzitna nemocnica Martin
  • Fakultna nemocnica Nitra
  • Fakultna nemocnica Trnava
  • Hospital Universitario de Getafe
  • C.A.U. de León - H. de León
  • Hospital Arnau de Vilanova
  • Hospital General Universitario Gregorio Marañón
  • Hospital Virgen de la Arrixaca
  • Hospital de Sant Joan Despí Moisès Broggi
  • Hospital Universitario Nuestra Senora de la Candelaria
  • Complejo Hospitalario Universitario de Santiago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mavenclad®

Arm Description

Outcomes

Primary Outcome Measures

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, at 4 Years

Secondary Outcome Measures

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 Scores at 4 Years
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 Scores at 4 Years

Full Information

First Posted
February 26, 2021
Last Updated
September 12, 2023
Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT04776213
Brief Title
Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
June 20, 2023 (Actual)
Study Completion Date
June 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple sclerosis, Health related quality of life, Mavenclad®, Relapsing Multiple Sclerosis, Cladribine, Cognitive impairment cognition, Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mavenclad®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Mavenclad®
Intervention Description
This low interventional extension study involves the follow up of participants in the parent study. The participants will be followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.
Primary Outcome Measure Information:
Title
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, at 4 Years
Time Frame
Up to 4 years after initial dose of Mavenclad® in parent study
Secondary Outcome Measure Information:
Title
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 Scores at 4 Years
Time Frame
Baseline (baseline of parent study), 4 years after initial dose of Mavenclad® in parent study
Title
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 Scores at 4 Years
Time Frame
Month 24 after initial dose of Mavenclad® in parent study, 4 years after initial dose of Mavenclad® in parent study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Responsible
Organizational Affiliation
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Eva Maida
City
Vienna
Country
Austria
Facility Name
FN u sv. Anny Brno
City
Brno
Country
Czechia
Facility Name
FN Hradec Králové
City
Hradec Kralove
Country
Czechia
Facility Name
Nemocnice Jihlava, p.o.
City
Jihlava
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady
City
Praha 10
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
Country
Czechia
Facility Name
Nemocnice Teplice
City
Teplice
Country
Czechia
Facility Name
Glostrup Sygehus
City
Glostrup
Country
Denmark
Facility Name
Odense Univeristy Hospital
City
Odense
Country
Denmark
Facility Name
Centre hospitalier de la Côte Basque - Saint Léon
City
Bayonne
Country
France
Facility Name
Pellegrin
City
Bordeaux
Country
France
Facility Name
CHU de la Côte de Nacre
City
Caen
Country
France
Facility Name
Centre Hospitalier de Gonesse
City
Gonesse
Country
France
Facility Name
CHRU de Lille Hôpital Roger Salengro
City
Lille
Country
France
Facility Name
CHU Hôpital Nord Laennec
City
Nantes Cedex 01
Country
France
Facility Name
Hôpital de la Pitié-Salpétrière
City
Paris Cédex 13
Country
France
Facility Name
CHU de Poissy
City
Poissy Cedex
Country
France
Facility Name
Centre Universitaire de Rouen
City
Rouen Cedex
Country
France
Facility Name
CHU Tours - Hôpital Bretonneau
City
Tours Cedex
Country
France
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
City
Budapest
Country
Hungary
Facility Name
Semmelweis University II
City
Budapest
Country
Hungary
Facility Name
Uzsoki Utcai Korhaz
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
City
Debrecen
Country
Hungary
Facility Name
Valeomed Kft
City
Esztergom
Country
Hungary
Facility Name
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
City
Nyíregyháza
Country
Hungary
Facility Name
A.O.U. Ospedali Riuniti Umberto
City
Ancona
Country
Italy
Facility Name
University of Cagliari
City
Cagliari
Country
Italy
Facility Name
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
City
Catania
Country
Italy
Facility Name
Ospedale San Raffaele Giglio
City
Cefalù
Country
Italy
Facility Name
Instituto Nazionale Neurologico "Carlo Besta"
City
Milano
Country
Italy
Facility Name
Ospedale San Raffaele, IRCCS
City
Milano
Country
Italy
Facility Name
A.O. Universitaria Federico II
City
Napoli
Country
Italy
Facility Name
Policlinico Università della Campania L. Vanvitelli
City
Napoli
Country
Italy
Facility Name
A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
City
Palermo
Country
Italy
Facility Name
Azienda Ospedaliera S. Camillo Forlanini
City
Roma
Country
Italy
Facility Name
Neurological Center of Latium
City
Roma
Country
Italy
Facility Name
Ospedale Sant'Andrea Neurologia - Università La Sapienza
City
Roma
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
Country
Italy
Facility Name
Zuyderland
City
Sittard-Geleen
Country
Netherlands
Facility Name
COPERNICUS Podmiot Leczn. Sp z o.o.
City
Gdansk
Country
Poland
Facility Name
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
City
Katowice
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
City
Lodz
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
City
Lublin
Country
Poland
Facility Name
Centrum Medyczne Medyk
City
Rzeszow
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii - Dept of Neurology II
City
Warszawa
Country
Poland
Facility Name
Neuropoint s.r.o
City
Bratislava
Country
Slovakia
Facility Name
Univerzitna nemocnica Martin
City
Martin
Country
Slovakia
Facility Name
Fakultna nemocnica Nitra
City
Nitra
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
Country
Slovakia
Facility Name
Hospital Universitario de Getafe
City
Getafe
Country
Spain
Facility Name
C.A.U. de León - H. de León
City
León
Country
Spain
Facility Name
Hospital Arnau de Vilanova
City
Lleida
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
Country
Spain
Facility Name
Hospital Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital de Sant Joan Despí Moisès Broggi
City
Sant Joan Despí
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de la Candelaria
City
Santa Cruz de Tenerife
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0158
Description
Trial Awareness and Transparency website

Learn more about this trial

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

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