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

NCT ID: NCT03961204

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 662 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2021-05-13

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).

Conditions

Multiple Sclerosis (MS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Cohort A

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.

Group Type: OTHER

Data Collection

Intervention Type: OTHER

No study treatment was administered as part of this study

Interventions

Data Collection

No study treatment was administered as part of this study

Intervention Type: OTHER

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: collaborator

EMD Serono Research & Development Institute, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

MS Center of Atlanta

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Maryland, Baltimore - Maryland Center for MS

Baltimore, Maryland, United States

Empire Neurology, PC - Empire Neurology PC

Latham, New York, United States

Sanford Neuro Health Center - Neurology

Fargo, North Dakota, United States

OMRF

Oklahoma City, Oklahoma, United States

Rowan University School of Osteopathic Medicine - Department of Medicine

Philadelphia, Pennsylvania, 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 Králové, , Czechia

Fakultni nemocnice Olomouc - Neurologicka klinika

Olomouc, , Czechia

Fakultni nemocnice Ostrava - Dept of Neurology

Ostrava-Poruba, , Czechia

Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol

Prague, , Czechia

Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze

Prague, , 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

Nîmes, , France

CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique

Rennes, , France

Ltd. Pineo Medical Ecosystem

Tbilisi, , Georgia

S. Khechinashvili University Clinic

Tbilisi, , Georgia

Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie

Düsseldorf, , 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

Milan, , 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

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

Poznan, , Poland

Instytut Psychiatrii i Neurologii

Warsaw, , Poland

Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia

Lisbon, , Portugal

SC Sana Monitoring SRL.

Bucaresti, , Romania

Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I

Târgu Mureş, , Romania

Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II

Timișoara, , Romania

SAIH "Kemerovo Regional Clinical Hospital" - PARENT

Kemerovo, , Russia

BMI "Kursk Regional Clinical Hospital"

Kursk, , Russia

NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko

Moscow, , Russia

SBIH of Moscow "City Clinical Hospital # 24" - Branch 1

Moscow, , Russia

SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi

Moscow, , Russia

Medis

Nizhny Novgorod, , Russia

RSHI"State Novosibirsk Regional Clinical Hospital"

Novosibirsk, , Russia

SEIHPE "Rostov State Medical University of MoH of RF"

Rostov-on-Don, , Russia

LLC " International Clinic MEDEM"

Saint Petersburg, , Russia

Pavlov First Saint Petersburg State Medical University - PARENT

Saint Petersburg, , Russia

Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery

Saint Petersburg, , Russia

SBIH "Leningrad Regional Clinical Hospital"

Saint Petersburg, , Russia

SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin

Samara, , Russia

SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF

Saratov, , Russia

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, , Russia

Siberian State Medical University

Tomsk, , Russia

Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology

Tyumen, , Russia

SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology

Yaroslavl, , Russia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Center Nis - Clinic of Neurology

Niš, , Serbia

National Cancer Center

Goyang-si, , South Korea

Severance Hospital, Yonsei University

Seoul, , South Korea

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia

Santa Cruz de Tenerife, , Spain

Sahlgrenska Sjukhuset

Gothenburg, , 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

Countries

United States; Australia; Austria; Belgium; Bulgaria; Canada; Croatia; Czechia; Estonia; Finland; France; Georgia; Germany; Italy; Lebanon; Lithuania; Norway; Poland; Portugal; Romania; Russia; Serbia; South Korea; Spain; Sweden; Switzerland; Tunisia; Ukraine; United Kingdom

References

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.

Reference Type: RESULT

PMID: 37012898 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0026

Trial Awareness and Transparency website

https://medical.emdserono.com/en_US/home.html

US Medical Information website, Medical Resources

Other Identifiers

2019-000069-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS700568_0026

Identifier Type: -

Identifier Source: org_study_id