Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS (CLASSIC-MS)
- Conditions
- Multiple Sclerosis (MS)
- Interventions
- Other: Data Collection
- Registration Number
- NCT03961204
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 662
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort A Data Collection The participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection.
- Primary Outcome Measures
Name Time Method Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher 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) EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day. Score of 8.0 is defined as Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher 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) EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as "intermittent or unilateral constant assistance (cane, crutch and brace) required to walk about 100 meters with or without resting".
Clinical and Demographic Characteristic: Age, Disease Duration At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Clinical and demographic characteristics including age and disease duration is reported in the form of long term responders and non-responder. Here long term responder is defined as study participants not requiring disease modifying drug (DMD) 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory \& cerebral functions, as well as walking ability. EDSS scores range from 0.0 (normal) to 10.0 (dead). Clinical characteristics of EDSS score in form of long-term responders \& non-responder was reported for at parent study baseline (based on retrospective data collection \[based on chart review\] at study visit 1) \& study visit 1. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study.
Clinical Characteristic: Number of Relapses At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Relapse was defined as participant-reported symptoms \& objectively observed signs typical of an acute inflammatory demyelinating event in CNS, developing acutely or sub-acutely with duration of at least 24 hours, in absence of fever or infection. Clinical characteristics of number of relapses during last year before enrollment of parent study (it is reported based on retrospective data collection \[based on chart review\] at study visit 1) in the form of long-term responders \& non-responder was reported. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
T2-weighted (T2-W) Lesion Volume At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) T2-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Total Brain Volume At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Brain volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Number of Participants in Each Category of Clinical and Demographic Characteristics At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Clinical and demographic characteristics included gender, race, disease classification (relapsing remitting multiple sclerosis \[RRMS\], Secondary Progressive Multiple Sclerosis \[SPMS\], unknown \& no MS disease), Prior use of DMDs \& high-disease activity (HAD) status, education level and employment status. Number of participants in each category of clinical and demographic characteristics were reported in form of long term responders \& non-responder. Here long term responder is defined as participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study.
Number of Total T1-weighted (T1-W) Lesions At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Total number of T1-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Number of Total T2-weighted (T2-W) Lesions At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) Total number of T2-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
T1-weighted (T1-W) Lesion Volume At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) T1-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Trial Locations
- Locations (99)
S. Khechinashvili University Clinic
🇬🇪Tbilisi, Georgia
Bellevue Medical Center
🇱🇧Beirut, Lebanon
Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie
🇦🇹Linz, Austria
MHAT - "National Heart Hospital" EAD - Multiple Clinics
🇧🇬Sofia, Bulgaria
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Canada
Recherche Sepmus, Inc.
🇨🇦Greenfield Park, Canada
Empire Neurology, PC - Empire Neurology PC
🇺🇸Latham, New York, United States
Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze
🇨🇿Praha 2, Czechia
MS Center of Atlanta
🇺🇸Atlanta, Georgia, United States
Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni
🇨🇿Hradec Kralove, Czechia
University of Maryland, Baltimore - Maryland Center for MS
🇺🇸Baltimore, Maryland, United States
Rowan University School of Osteopathic Medicine - Department of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Sanford Neuro Health Center - Neurology
🇺🇸Fargo, North Dakota, United States
OMRF
🇺🇸Oklahoma City, Oklahoma, United States
University of Sydney
🇦🇺Camperdown, Australia
Limburgs Universitair Centrum
🇧🇪Hasselt, Belgium
Tartu University Hospital
🇪🇪Tartu, Estonia
Fakultni nemocnice v Motole - Internà klinika 2. LF UK a FN Motol
🇨🇿Praha 5, Czechia
Ltd. Pineo Medical Ecosystem
🇬🇪Tbilisi, Georgia
Ospedale Sant'Andrea di Roma - MS Center
🇮🇹Rome, Italy
CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique
🇫🇷Rennes cedex 09, France
Diakoniekrankenhaus Henriettenstiftung GgmBH
🇩🇪Hanover, Germany
Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla
🇮🇹Chieti, Italy
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
🇮🇹Gallarate, Italy
Klinik Und Poliklinik Fur Neurologie
🇩🇪Regensburg, Germany
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
🇵🇱Poznań, Poland
Sahlgrenska Sjukhuset
🇸🇪Göteborg, Sweden
Clinical Center Nis - Clinic of Neurology
🇷🇸Nis, Serbia
SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis
🇺🇦Kharkiv, Ukraine
Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia
🇪🇸Santa Cruz de Tenerife, Spain
Nottingham University Hospital - Division of Clinical Neurology
🇬🇧Nottingham, United Kingdom
Hôpital Fattouma Bourghiba
🇹🇳Monastir, Tunisia
Hopital Militaire de Tunis
🇹🇳Tunis, Tunisia
Hospital Universitario Reina Sofia
🇪🇸Córdoba, Spain
Royal Hallamshire Hospital - Dept of Neurology
🇬🇧Sheffield, United Kingdom
Hopital Roger Salengro - CHU Lille - service de neurologie D
🇫🇷Lille, France
SBIH of Moscow "City Clinical Hospital # 24" - Branch 1
🇷🇺Moscow, Russian Federation
BMI "Kursk Regional Clinical Hospital"
🇷🇺Kursk, Russian Federation
SEIHPE "Rostov State Medical University of MoH of RF"
🇷🇺Rostov-on-don, Russian Federation
Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie
🇩🇪Rostock, Germany
Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni
🇨🇿Teplice, Czechia
Military Medical Academy - MHAT - Pleven
🇧🇬Pleven, Bulgaria
Burnaby Hospital Vancouver
🇨🇦Burnaby, Canada
MHAT - Shumen, AD
🇧🇬Shumen, Bulgaria
University Hospital "Saint Naum"
🇧🇬Sofia, Bulgaria
Clinique Neuro-Outaouais
🇨🇦Gatineau, Canada
Clinical Hospital Centar Split
ðŸ‡ðŸ‡·Split, Croatia
Fakultni nemocnice Olomouc - Neurologicka klinika
🇨🇿Olomouc, Czechia
General Hospital Varazdin
ðŸ‡ðŸ‡·Varaždin, Croatia
Fakultni nemocnice Ostrava - Dept of Neurology
🇨🇿Ostrava-Poruba, Czechia
Neuro NEO Oy - NEO Research
🇫🇮Turku, Finland
CHU de Nîmes - Hôpital Carémeau - Service de Neurologie
🇫🇷Nimes, France
Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie
🇩🇪Duesseldorf, Germany
A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia
🇮🇹Bari, Italy
Azienda Ospadaliero Universitaria San Martino - PARENT
🇮🇹Genova, Italy
Ospedale San Raffaele - U.O. di Neurologia
🇮🇹Milano, Italy
Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla
🇮🇹Orbassano, Italy
Azienda Ospedaliera San Camillo Forlanini
🇮🇹Roma, Italy
Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica
🇮🇹Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla
🇮🇹Roma, Italy
Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U
🇮🇹Pavia, Italy
Severance Hospital, Yonsei University
🇰🇷Seoul, Korea, Republic of
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon
National Cancer Center
🇰🇷Goyang-si, Korea, Republic of
Department of Neurology, Haukeland University
🇳🇴Haukeland, Norway
Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic
🇱🇹Kaunas, Lithuania
St Olavs Hospital - PARENT
🇳🇴Trondheim, Norway
Uniwersyteckie Centrum Kliniczne - Dept of Neurology
🇵🇱Gdansk, Poland
Szpital im. Mikołaja Kopernika - Neurology
🇵🇱Gdansk, Poland
Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
🇵🇱Lublin, Poland
Instytut Psychiatrii i Neurologii
🇵🇱Warszawa, Poland
SC Sana Monitoring SRL.
🇷🇴Bucaresti, Romania
Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II
🇷🇴Timisoara, Romania
Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
🇷🇴Targu Mures, Romania
SAIH "Kemerovo Regional Clinical Hospital" - PARENT
🇷🇺Kemerovo, Russian Federation
NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko
🇷🇺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
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
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
SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin
🇷🇺Samara, 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
SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology
🇷🇺Yaroslavl, Russian Federation
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology
🇷🇺Tyumen, Russian Federation
University Hospital of Liege
🇧🇪Seraing, Belgium
Multiprofile Hospital for Active Treatment - Stara Zagora
🇧🇬Stara Zagora, Bulgaria
Astra Team Clinic
🇪🇪Tallinn, Estonia
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
🇨ðŸ‡Lausanne, Switzerland
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia
🇵🇹Lisboa, Portugal
Hôpital Habib Bourguiba - Service de Neurologie
🇹🇳Sfax, Tunisia
Vinnitsa State Medical University - Neurology dept
🇺🇦Vinnytsia, Ukraine