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

Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials

Sponsors

Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Collaborator: Merck KGaA, Darmstadt, Germany

Source EMD Serono
Brief Summary

The purpose of this study is to explore the long-term outcomes, durability of effect, and real world treatment patterns in participants previously participating in the Phase 3 oral cladribine in first clinical demyelinating event(ORACLE MS) and Oral Cladribine in participants with relapsing remitting multiple sclerosis, extension study (CLARITY/CLARITY-EXT) clinical trials with the study number of 28821 (NCT00725985), 25643 (NCT00213135) and 27820 (NCT00641537) respectively.

Overall Status Recruiting
Start Date 2019-08-15
Completion Date 2021-09-30
Primary Completion Date 2021-04-08
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher Within 2 weeks of signing the informed consent form
Secondary Outcome
Measure Time Frame
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher Within 2 weeks of signing the informed consent form
Number of Participants in Each Category of Clinical Characteristics Within 2 weeks of signing the informed consent form
Disease Duration Within 2 weeks of signing the informed consent form
Relapse Duration Within 2 weeks of signing the informed consent form
Total Volume of Time Constant 2 (T2) Lesions Within 6-14 weeks of signing the informed consent form
Total Number of Time Constant 2 (T2) Lesions Within 6-14 weeks of signing the informed consent form
Number of Time Constant 1 (T1) Hypointense Lesions Within 6-14 weeks of signing the informed consent form
Volume of Time Constant 1 (T1) Hypointense Lesions Within 6-14 weeks of signing the informed consent form
Brain Volume Within 6-14 weeks of signing the informed consent form
Ventricular Volume Within 6-14 weeks of signing the informed consent form
Enrollment 727
Condition
Intervention

Intervention Type: Drug

Intervention Name: Cladribine

Description: Participants will not receive any investigational medicinal product (IMP) in the study. Participants will be eligible who had participated in parent studies 25643 (NCT00213135), 27820 (NCT00641537) and 28821 (NCT00725985) and had received Cladribine tablets or placebo.

Arm Group Label: Cladribine

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Medical Responsible Study Director Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Contact

Last Name: US Medical Information

Phone: 888-275-7376

Email: [email protected]

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

Australia

Austria

Belgium

Bulgaria

Canada

Croatia

Czechia

Estonia

Finland

France

Georgia

Germany

Italy

Korea, Republic of

Lebanon

Lithuania

Norway

Poland

Portugal

Romania

Russian Federation

Serbia

Spain

Sweden

Switzerland

Tunisia

Ukraine

United Kingdom

United States

Verification Date

2021-02-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Cladribine

Type: Experimental

Acronym CLASSIC-MS
Patient Data Yes
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

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