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

Primary Purpose

Multiple Sclerosis (MS)

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Data Collection
Sponsored by
EMD Serono Research & Development Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis (MS) focused on measuring Multiple Sclerosis, Cladribine, High Disease Activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MS Center of Atlanta
  • Rush University Medical Center
  • University of Maryland, Baltimore - Maryland Center for MS
  • Empire Neurology, PC - Empire Neurology PC
  • Sanford Neuro Health Center - Neurology
  • OMRF
  • Rowan University School of Osteopathic Medicine - Department of Medicine
  • University of Sydney
  • Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie
  • Limburgs Universitair Centrum
  • University Hospital of Liege
  • Military Medical Academy - MHAT - Pleven
  • MHAT - Shumen, AD
  • MHAT - "National Heart Hospital" EAD - Multiple Clinics
  • University Hospital "Saint Naum"
  • Multiprofile Hospital for Active Treatment - Stara Zagora
  • Burnaby Hospital Vancouver
  • Clinique Neuro-Outaouais
  • Recherche Sepmus, Inc.
  • The Ottawa Hospital - General Campus
  • Clinical Hospital Centar Split
  • General Hospital Varazdin
  • Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni
  • Fakultni nemocnice Olomouc - Neurologicka klinika
  • Fakultni nemocnice Ostrava - Dept of Neurology
  • Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze
  • Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol
  • Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni
  • Astra Team Clinic
  • Tartu University Hospital
  • Neuro NEO Oy - NEO Research
  • Hopital Roger Salengro - CHU Lille - service de neurologie D
  • CHU de Nîmes - Hôpital Carémeau - Service de Neurologie
  • CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique
  • Ltd. Pineo Medical Ecosystem
  • S. Khechinashvili University Clinic
  • Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie
  • Diakoniekrankenhaus Henriettenstiftung GgmBH
  • Klinik Und Poliklinik Fur Neurologie
  • Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia
  • A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I
  • Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla
  • Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)
  • Azienda Ospadaliero Universitaria San Martino - PARENT
  • Ospedale San Raffaele - U.O. di Neurologia
  • Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica
  • Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla
  • Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U
  • Azienda Ospedaliera San Camillo Forlanini
  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla
  • Ospedale Sant'Andrea di Roma - MS Center
  • National Cancer Center
  • Severance Hospital, Yonsei University
  • American University of Beirut Medical Center
  • Bellevue Medical Center
  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic
  • Department of Neurology, Haukeland University
  • St Olavs Hospital - PARENT
  • Szpital im. Mikołaja Kopernika - Neurology
  • Uniwersyteckie Centrum Kliniczne - Dept of Neurology
  • Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny
  • Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
  • Instytut Psychiatrii i Neurologii
  • Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia
  • SC Sana Monitoring SRL.
  • Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I
  • Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II
  • SAIH "Kemerovo Regional Clinical Hospital" - PARENT
  • BMI "Kursk Regional Clinical Hospital"
  • NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko
  • SBIH of Moscow "City Clinical Hospital # 24" - Branch 1
  • SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi
  • Medis
  • RSHI"State Novosibirsk Regional Clinical Hospital"
  • SEIHPE "Rostov State Medical University of MoH of RF"
  • LLC " International Clinic MEDEM"
  • Pavlov First Saint Petersburg State Medical University - PARENT
  • SBIH "Leningrad Regional Clinical Hospital"
  • SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin
  • SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF
  • RSBIH "Smolensk Regional Clinical Hospital"
  • Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery
  • Siberian State Medical University
  • Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology
  • SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology
  • Clinical Center of Serbia
  • Clinical Center Nis - Clinic of Neurology
  • Hospital Universitario Reina Sofia
  • Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia
  • Sahlgrenska Sjukhuset
  • (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
  • Hôpital Fattouma Bourghiba
  • Hôpital Habib Bourguiba - Service de Neurologie
  • Hopital Militaire de Tunis
  • SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis
  • Vinnitsa State Medical University - Neurology dept
  • Nottingham University Hospital - Division of Clinical Neurology
  • Royal Hallamshire Hospital - Dept of Neurology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cohort A

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher
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

Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
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
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.
Number of Participants in Each Category of Clinical and Demographic Characteristics
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.
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
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
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.
Number of Total T1-weighted (T1-W) Lesions
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
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
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.
T2-weighted (T2-W) Lesion Volume
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
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.

Full Information

First Posted
May 22, 2019
Last Updated
April 8, 2022
Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03961204
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
February 27, 2021 (Actual)
Study Completion Date
May 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMD Serono Research & Development Institute, Inc.
Collaborators
Merck KGaA, Darmstadt, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis (MS)
Keywords
Multiple Sclerosis, Cladribine, High Disease Activity

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
662 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Data Collection
Intervention Description
No study treatment was administered as part of this study
Primary Outcome Measure Information:
Title
Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
Description
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".
Time Frame
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)
Title
Clinical and Demographic Characteristic: Age, Disease Duration
Description
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.
Time Frame
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Number of Participants in Each Category of Clinical and Demographic Characteristics
Description
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.
Time Frame
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
Description
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.
Time Frame
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Clinical Characteristic: Number of Relapses
Description
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.
Time Frame
At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Number of Total T1-weighted (T1-W) Lesions
Description
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.
Time Frame
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Number of Total T2-weighted (T2-W) Lesions
Description
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.
Time Frame
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
T1-weighted (T1-W) Lesion Volume
Description
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.
Time Frame
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
T2-weighted (T2-W) Lesion Volume
Description
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.
Time Frame
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Title
Total Brain Volume
Description
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.
Time Frame
At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
IPD Sharing Time Frame
Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
IPD Sharing Access Criteria
Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
IPD Sharing URL
https://bit.ly/IPD21
Links:
URL
https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0026
Description
Trial Awareness and Transparency website
URL
https://medical.emdserono.com/en_US/home.html
Description
US Medical Information website, Medical Resources

Learn more about this trial

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

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