Multiple Sclerosis Clinical Trial

Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)

Summary

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo
Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo
Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol

Exclusion Criteria:

Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
For study participants at selected sites where MRI assessment will be conducted following exclusion criteria will apply to MRI assessments only:
Female study participants who are pregnant
Participants who are taking Cladribine Tablets as part of another study at the time of the start of this study

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

662

Study ID:

NCT03961204

Recruitment Status:

Completed

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 7 Locations for this study

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MS Center of Atlanta
Atlanta Georgia, 30327, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
University of Maryland, Baltimore - Maryland Center for MS
Baltimore Maryland, 21201, United States
Empire Neurology, PC - Empire Neurology PC
Latham New York, 12110, United States
Sanford Neuro Health Center - Neurology
Fargo North Dakota, 58103, United States
OMRF
Oklahoma City Oklahoma, 73104, United States
Rowan University School of Osteopathic Medicine - Department of Medicine
Philadelphia Pennsylvania, 19106, United States
University of Sydney
Camperdown , , Australia
Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie
Linz , , Austria
Limburgs Universitair Centrum
Hasselt , , Belgium
University Hospital of Liege
Seraing , , Belgium
Military Medical Academy - MHAT - Pleven
Pleven , , Bulgaria
MHAT - Shumen, AD
Shumen , , Bulgaria
MHAT - "National Heart Hospital" EAD - Multiple Clinics
Sofia , , Bulgaria
University Hospital "Saint Naum"
Sofia , , Bulgaria
Multiprofile Hospital for Active Treatment - Stara Zagora
Stara Zagora , , Bulgaria
Burnaby Hospital Vancouver
Burnaby , , Canada
Clinique Neuro-Outaouais
Gatineau , , Canada
Recherche Sepmus, Inc.
Greenfield Park , , Canada
The Ottawa Hospital - General Campus
Ottawa , , Canada
Clinical Hospital Centar Split
Split , , Croatia
General Hospital Varazdin
Varaždin , , Croatia
Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni
Hradec Kralove , , Czechia
Fakultni nemocnice Olomouc - Neurologicka klinika
Olomouc , , Czechia
Fakultni nemocnice Ostrava - Dept of Neurology
Ostrava-Poruba , , Czechia
Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze
Praha 2 , , Czechia
Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol
Praha 5 , , Czechia
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni
Teplice , , Czechia
Astra Team Clinic
Tallinn , , Estonia
Tartu University Hospital
Tartu , , Estonia
Neuro NEO Oy - NEO Research
Turku , , Finland
Hopital Roger Salengro - CHU Lille - service de neurologie D
Lille , , France
CHU de Nîmes - Hôpital Carémeau - Service de Neurologie
Nimes , , France
CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique
Rennes cedex 09 , , France
Ltd. Pineo Medical Ecosystem
Tbilisi , , Georgia
S. Khechinashvili University Clinic
Tbilisi , , Georgia
Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie
Duesseldorf , , Germany
Diakoniekrankenhaus Henriettenstiftung GgmBH
Hanover , , Germany
Klinik Und Poliklinik Fur Neurologie
Regensburg , , Germany
Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie
Rostock , , Germany
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia
Bari , , Italy
A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I
Catania , , Italy
Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla
Chieti , , Italy
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
Gallarate , , Italy
Azienda Ospadaliero Universitaria San Martino - PARENT
Genova , , Italy
Ospedale San Raffaele - U.O. di Neurologia
Milano , , Italy
Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica
Napoli , , Italy
Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla
Orbassano , , Italy
Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U
Pavia , , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma , , Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla
Roma , , Italy
Ospedale Sant'Andrea di Roma - MS Center
Rome , , Italy
National Cancer Center
Goyang-si , , Korea, Republic of
Severance Hospital, Yonsei University
Seoul , , Korea, Republic of
American University of Beirut Medical Center
Beirut , , Lebanon
Bellevue Medical Center
Beirut , , Lebanon
Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic
Kaunas , , Lithuania
Department of Neurology, Haukeland University
Haukeland , , Norway
St Olavs Hospital - PARENT
Trondheim , , Norway
Szpital im. Mikołaja Kopernika - Neurology
Gdansk , , Poland
Uniwersyteckie Centrum Kliniczne - Dept of Neurology
Gdansk , , Poland
Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
Lublin , , Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
Poznań , , Poland
Instytut Psychiatrii i Neurologii
Warszawa , , Poland
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia
Lisboa , , Portugal
SC Sana Monitoring SRL.
Bucaresti , , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
Targu Mures , , Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II
Timisoara , , Romania
SAIH "Kemerovo Regional Clinical Hospital" - PARENT
Kemerovo , , Russian Federation
BMI "Kursk Regional Clinical Hospital"
Kursk , , Russian Federation
NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko
Moscow , , Russian Federation
SBIH of Moscow "City Clinical Hospital # 24" - Branch 1
Moscow , , Russian Federation
SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi
Moscow , , Russian Federation
Medis
Nizhny Novgorod , , Russian Federation
RSHI"State Novosibirsk Regional Clinical Hospital"
Novosibirsk , , Russian Federation
SEIHPE "Rostov State Medical University of MoH of RF"
Rostov-on-don , , Russian Federation
LLC " International Clinic MEDEM"
Saint-Petersburg , , Russian Federation
Pavlov First Saint Petersburg State Medical University - PARENT
Saint-Petersburg , , Russian Federation
SBIH "Leningrad Regional Clinical Hospital"
Saint-Petersburg , , Russian Federation
SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin
Samara , , Russian Federation
SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
Saratov , , Russian Federation
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk , , Russian Federation
Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery
St. Petersburg , , Russian Federation
Siberian State Medical University
Tomsk , , Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology
Tyumen , , Russian Federation
SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology
Yaroslavl , , Russian Federation
Clinical Center of Serbia
Belgrade , , Serbia
Clinical Center Nis - Clinic of Neurology
Nis , , Serbia
Hospital Universitario Reina Sofia
Córdoba , , Spain
Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia
Santa Cruz de Tenerife , , Spain
Sahlgrenska Sjukhuset
Göteborg , , Sweden
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
Lausanne , , Switzerland
Hôpital Fattouma Bourghiba
Monastir , , Tunisia
Hôpital Habib Bourguiba - Service de Neurologie
Sfax , , Tunisia
Hopital Militaire de Tunis
Tunis , , Tunisia
SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis
Kharkiv , , Ukraine
Vinnitsa State Medical University - Neurology dept
Vinnytsia , , Ukraine
Nottingham University Hospital - Division of Clinical Neurology
Nottingham , , United Kingdom
Royal Hallamshire Hospital - Dept of Neurology
Sheffield , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

662

Study ID:

NCT03961204

Recruitment Status:

Completed

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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