Clinical trial NCT04776213: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Health related quality of life
Mavenclad®
Relapsing Multiple Sclerosis
Cladribine
Cognitive impairment cognition
Fatigue
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2021-03-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
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
timeFrame: Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)
Secondary outcomes:
measure: 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
timeFrame: Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
measure: 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
timeFrame: Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Eva Maida
city: Brno
country: Czechia
facility: FN u sv. Anny Brno
city: Hradec Kralove
country: Czechia
facility: FN Hradec Králové
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava, p.o.
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Faculty Hospital Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Teplice
country: Czechia
facility: Nemocnice Teplice
city: Glostrup
country: Denmark
facility: Glostrup Sygehus
city: Odense
country: Denmark
facility: Odense Univeristy Hospital
city: Bayonne
country: France
facility: Centre hospitalier de la Côte Basque - Saint Léon
city: Bordeaux
country: France
facility: Pellegrin
city: Caen
country: France
facility: CHU de la Côte de Nacre
city: Gonesse
country: France
facility: Centre Hospitalier de Gonesse
city: Lille
country: France
facility: CHRU de Lille Hôpital Roger Salengro
city: Nantes Cedex 01
country: France
facility: CHU Hôpital Nord Laennec
city: Paris Cédex 13
country: France
facility: Hôpital de la Pitié-Salpétrière
city: Poissy Cedex
country: France
facility: CHU de Poissy
city: Rouen Cedex
country: France
facility: Centre Universitaire de Rouen
city: Tours Cedex
country: France
facility: CHU Tours - Hôpital Bretonneau
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
city: Budapest
country: Hungary
facility: Semmelweis University II
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum
city: Esztergom
country: Hungary
facility: Valeomed Kft
city: Nyíregyháza
country: Hungary
facility: Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti Umberto
city: Cagliari
country: Italy
facility: University of Cagliari
city: Catania
country: Italy
facility: PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
city: Cefalù
country: Italy
facility: Ospedale San Raffaele Giglio
city: Milano
country: Italy
facility: Instituto Nazionale Neurologico "Carlo Besta"
city: Milano
country: Italy
facility: Ospedale San Raffaele, IRCCS
city: Napoli
country: Italy
facility: A.O. Universitaria Federico II
city: Napoli
country: Italy
facility: Policlinico Università della Campania L. Vanvitelli
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
city: Roma
country: Italy
facility: Azienda Ospedaliera S. Camillo Forlanini
city: Roma
country: Italy
facility: Neurological Center of Latium
city: Roma
country: Italy
facility: Ospedale Sant'Andrea Neurologia - Università La Sapienza
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczn. Sp z o.o.
city: Katowice
country: Poland
facility: M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
city: Lodz
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 i.m. Norberta Barlickie
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak
city: Rzeszow
country: Poland
facility: Centrum Medyczne Medyk
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii - Dept of Neurology II
city: Bratislava
country: Slovakia
facility: Neuropoint s.r.o
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Nitra
country: Slovakia
facility: Fakultna nemocnica Nitra
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
city: León
country: Spain
facility: C.A.U. de León - H. de León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Murcia
country: Spain
facility: Hospital Virgen de la Arrixaca
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Joan Despí Moisès Broggi
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Senora de la Candelaria
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: