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

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776213
• Other study ID #: MS700568_0158
• Secondary ID: 2020-003874-30
• Status: Completed
• Phase: Phase 4
• Start date: February 23, 2021
• Est. completion date: June 20, 2023

Study information

• Verified date: May 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 initial dose of Mavenclad® tablets.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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®.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Austria,  Czechia,  Denmark,  France,  Hungary,  Italy,  Netherlands,  Poland,  Slovakia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)
Secondary	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.	Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
Secondary	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.	Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

External Links

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