Clinical trial NCT03961204: Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
Official title: Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis (MS)
Keywords: Multiple Sclerosis
Cladribine
High Disease Activity
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-05-23
Enrollment: 662
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).


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

Primary outcomes:
measure: Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher
timeFrame: 3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
Secondary outcomes:
measure: Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
timeFrame: At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
measure: Clinical and Demographic Characteristic: Age, Disease Duration
timeFrame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Number of Participants in Each Category of Clinical and Demographic Characteristics
timeFrame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
timeFrame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Clinical Characteristic: Number of Relapses
timeFrame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Number of Total T1-weighted (T1-W) Lesions
timeFrame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Number of Total T2-weighted (T2-W) Lesions
timeFrame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: T1-weighted (T1-W) Lesion Volume
timeFrame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: T2-weighted (T2-W) Lesion Volume
timeFrame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
measure: Total Brain Volume
timeFrame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: MS Center of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Baltimore - Maryland Center for MS
state: Maryland
city: Latham
country: United States
facility: Empire Neurology, PC - Empire Neurology PC
state: New York
city: Fargo
country: United States
facility: Sanford Neuro Health Center - Neurology
state: North Dakota
city: Oklahoma City
country: United States
facility: OMRF
state: Oklahoma
city: Philadelphia
country: United States
facility: Rowan University School of Osteopathic Medicine - Department of Medicine
state: Pennsylvania
city: Camperdown
country: Australia
facility: University of Sydney
city: Linz
country: Austria
facility: Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie
city: Hasselt
country: Belgium
facility: Limburgs Universitair Centrum
city: Seraing
country: Belgium
facility: University Hospital of Liege
city: Pleven
country: Bulgaria
facility: Military Medical Academy - MHAT - Pleven
city: Shumen
country: Bulgaria
facility: MHAT - Shumen, AD
city: Sofia
country: Bulgaria
facility: MHAT - "National Heart Hospital" EAD - Multiple Clinics
city: Sofia
country: Bulgaria
facility: University Hospital "Saint Naum"
city: Stara Zagora
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Stara Zagora
city: Burnaby
country: Canada
facility: Burnaby Hospital Vancouver
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
city: Greenfield Park
country: Canada
facility: Recherche Sepmus, Inc.
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
city: Split
country: Croatia
facility: Clinical Hospital Centar Split
city: Varaždin
country: Croatia
facility: General Hospital Varazdin
city: Hradec Kralove
country: Czechia
facility: Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc - Neurologicka klinika
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava - Dept of Neurology
city: Praha 2
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol
city: Teplice
country: Czechia
facility: Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni
city: Tallinn
country: Estonia
facility: Astra Team Clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Turku
country: Finland
facility: Neuro NEO Oy - NEO Research
city: Lille
country: France
facility: Hopital Roger Salengro - CHU Lille - service de neurologie D
city: Nimes
country: France
facility: CHU de Nîmes - Hôpital Carémeau - Service de Neurologie
city: Rennes cedex 09
country: France
facility: CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique
city: Tbilisi
country: Georgia
facility: Ltd. Pineo Medical Ecosystem
city: Tbilisi
country: Georgia
facility: S. Khechinashvili University Clinic
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie
city: Hanover
country: Germany
facility: Diakoniekrankenhaus Henriettenstiftung GgmBH
city: Regensburg
country: Germany
facility: Klinik Und Poliklinik Fur Neurologie
city: Rostock
country: Germany
facility: Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie
city: Bari
country: Italy
facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia
city: Catania
country: Italy
facility: A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla
city: Gallarate
country: Italy
facility: Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
city: Genova
country: Italy
facility: Azienda Ospadaliero Universitaria San Martino - PARENT
city: Milano
country: Italy
facility: Ospedale San Raffaele - U.O. di Neurologia
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica
city: Orbassano
country: Italy
facility: Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla
city: Pavia
country: Italy
facility: Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla
city: Rome
country: Italy
facility: Ospedale Sant'Andrea di Roma - MS Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Beirut
country: Lebanon
facility: Bellevue Medical Center
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic
city: Haukeland
country: Norway
facility: Department of Neurology, Haukeland University
city: Trondheim
country: Norway
facility: St Olavs Hospital - PARENT
city: Gdansk
country: Poland
facility: Szpital im. Mikołaja Kopernika - Neurology
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne - Dept of Neurology
city: Lublin
country: Poland
facility: Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
city: Poznań
country: Poland
facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia
city: Bucaresti
country: Romania
facility: SC Sana Monitoring SRL.
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II
city: Kemerovo
country: Russian Federation
facility: SAIH "Kemerovo Regional Clinical Hospital" - PARENT
city: Kursk
country: Russian Federation
facility: BMI "Kursk Regional Clinical Hospital"
city: Moscow
country: Russian Federation
facility: NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City Clinical Hospital # 24" - Branch 1
city: Moscow
country: Russian Federation
facility: SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi
city: Nizhny Novgorod
country: Russian Federation
facility: Medis
city: Novosibirsk
country: Russian Federation
facility: RSHI"State Novosibirsk Regional Clinical Hospital"
city: Rostov-on-don
country: Russian Federation
facility: SEIHPE "Rostov State Medical University of MoH of RF"
city: Saint-Petersburg
country: Russian Federation
facility: LLC " International Clinic MEDEM"
city: Saint-Petersburg
country: Russian Federation
facility: Pavlov First Saint Petersburg State Medical University - PARENT
city: Saint-Petersburg
country: Russian Federation
facility: SBIH "Leningrad Regional Clinical Hospital"
city: Samara
country: Russian Federation
facility: SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin
city: Saratov
country: Russian Federation
facility: SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
city: Smolensk
country: Russian Federation
facility: RSBIH "Smolensk Regional Clinical Hospital"
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
city: Tyumen
country: Russian Federation
facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology
city: Yaroslavl
country: Russian Federation
facility: SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Nis
country: Serbia
facility: Clinical Center Nis - Clinic of Neurology
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia
city: Göteborg
country: Sweden
facility: Sahlgrenska Sjukhuset
city: Lausanne
country: Switzerland
facility: (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
city: Monastir
country: Tunisia
facility: Hôpital Fattouma Bourghiba
city: Sfax
country: Tunisia
facility: Hôpital Habib Bourguiba - Service de Neurologie
city: Tunis
country: Tunisia
facility: Hopital Militaire de Tunis
city: Kharkiv
country: Ukraine
facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis
city: Vinnytsia
country: Ukraine
facility: Vinnitsa State Medical University - Neurology dept
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital - Division of Clinical Neurology
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital - Dept of Neurology
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Giovannoni G, Boyko A, Correale J, Edan G, Freedman MS, Montalban X, Rammohan K, Stefoski D, Yamout B, Leist T, Aydemir A, Borsi L, Verdun di Cantogno E. Long-term follow-up of patients with relapsing multiple sclerosis from the CLARITY/CLARITY Extension cohort of CLASSIC-MS: An ambispective study. Mult Scler. 2023 May;29(6):719-730. doi: 10.1177/13524585231161494. Epub 2023 Apr 3.