Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)
- Registration Number
- NCT04776213
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- 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
- Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study
- Participation in other studies.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mavenclad® Mavenclad® -
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
Trial Locations
- Locations (60)
CHRU de Lille Hôpital Roger Salengro
🇫🇷Lille, France
CHU Hôpital Nord Laennec
🇫🇷Nantes Cedex 01, France
Instituto Nazionale Neurologico "Carlo Besta"
🇮🇹Milano, Italy
Ospedale San Raffaele, IRCCS
🇮🇹Milano, Italy
Neurological Center of Latium
🇮🇹Roma, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
Zuyderland
🇳🇱Sittard-Geleen, Netherlands
Neuropoint s.r.o
🇸🇰Bratislava, Slovakia
Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet
🇭🇺Budapest, Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókór
🇭🇺Nyíregyháza, Hungary
COPERNICUS Podmiot Leczn. Sp z o.o.
🇵🇱Gdansk, Poland
Instytut Psychiatrii i Neurologii - Dept of Neurology II
🇵🇱Warszawa, Poland
Centrum Medyczne Medyk
🇵🇱Rzeszow, 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
Uzsoki Utcai Korhaz
🇭🇺Budapest, Hungary
Centre Hospitalier de Gonesse
🇫🇷Gonesse, France
Hôpital de la Pitié-Salpétrière
🇫🇷Paris Cédex 13, France
Eva Maida
🇦🇹Vienna, Austria
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
FN u sv. Anny Brno
🇨🇿Brno, Czechia
FN Hradec Králové
🇨🇿Hradec Kralove, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Czechia
Nemocnice Jihlava, p.o.
🇨🇿Jihlava, Czechia
Faculty Hospital Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Odense Univeristy Hospital
🇩🇰Odense, Denmark
Nemocnice Teplice
🇨🇿Teplice, Czechia
Glostrup Sygehus
🇩🇰Glostrup, Denmark
Pellegrin
🇫🇷Bordeaux, France
Centre hospitalier de la Côte Basque - Saint Léon
🇫🇷Bayonne, France
CHU de la Côte de Nacre
🇫🇷Caen, France
CHU de Poissy
🇫🇷Poissy Cedex, France
Centre Universitaire de Rouen
🇫🇷Rouen Cedex, France
CHU Tours - Hôpital Bretonneau
🇫🇷Tours Cedex, France
Semmelweis University II
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos- és Egészségtudományi Centrum
🇭🇺Debrecen, Hungary
Valeomed Kft
🇭🇺Esztergom, Hungary
University of Cagliari
🇮🇹Cagliari, Italy
A.O. Universitaria Federico II
🇮🇹Napoli, Italy
A.O.U. Ospedali Riuniti Umberto
🇮🇹Ancona, Italy
Ospedale San Raffaele Giglio
🇮🇹Cefalù, Italy
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
🇮🇹Catania, Italy
Policlinico Università della Campania L. Vanvitelli
🇮🇹Napoli, Italy
Azienda Ospedaliera S. Camillo Forlanini
🇮🇹Roma, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello U.O. Endocrinolog
🇮🇹Palermo, Italy
Ospedale Sant'Andrea Neurologia - Università La Sapienza
🇮🇹Roma, Italy
M.A.-Lek A.M. Maciejowscy S.C. Centrum Terapii SM
🇵🇱Katowice, Poland
Fakultna nemocnica Nitra
🇸🇰Nitra, Slovakia
Hospital Universitario de Getafe
🇪🇸Getafe, Spain
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
C.A.U. de León - H. de León
🇪🇸León, Spain
Hospital Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital de Sant Joan Despí Moisès Broggi
🇪🇸Sant Joan Despí, Spain
Hospital Virgen de la Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Nuestra Senora de la Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Complejo Hospitalario Universitario de Santiago
🇪🇸Santiago de Compostela, Spain