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)
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
Austria, Czechia, Denmark, France, Hungary, Italy, Netherlands, Poland, Slovakia, Spain,
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, at 4 Years | Up to 4 years after initial dose of Mavenclad® in parent study | ||
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 Scores at 4 Years | Baseline (baseline of parent study), 4 years after initial dose of Mavenclad® in parent study | ||
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 Scores at 4 Years | Month 24 after initial dose of Mavenclad® in parent study, 4 years after initial dose of Mavenclad® in parent study |
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