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

NCT03961204 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: MS700568_00262019-000069-19
• Study Type: interventional
• Target: 662
• Locations: 26 countries
• Sites: 94

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)

Keywords

Multiple Sclerosis; Cladribine; High Disease Activity

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (10)

• 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)

• 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)

• 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 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)

• 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)

Study Arms (1)

Cohort A

OTHER

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.

Other: Data Collection

Interventions

Data Collection OTHER

No study treatment was administered as part of this study

Cohort A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono Research & Development Institute, Inc.: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (99)

MS Center of Atlanta

Atlanta, Georgia, 30327, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Maryland, Baltimore - Maryland Center for MS

Baltimore, Maryland, 21201, United States

Location

Empire Neurology, PC - Empire Neurology PC

Latham, New York, 12110, United States

Location

Sanford Neuro Health Center - Neurology

Fargo, North Dakota, 58103, United States

Location

OMRF

Oklahoma City, Oklahoma, 73104, United States

Location

Rowan University School of Osteopathic Medicine - Department of Medicine

Philadelphia, Pennsylvania, 19106, United States

Location

University of Sydney

Camperdown, Australia

Location

Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie

Linz, Austria

Location

Limburgs Universitair Centrum

Hasselt, Belgium

Location

University Hospital of Liege

Seraing, Belgium

Location

Military Medical Academy - MHAT - Pleven

Pleven, Bulgaria

Location

MHAT - Shumen, AD

Shumen, Bulgaria

Location

MHAT - "National Heart Hospital" EAD - Multiple Clinics

Sofia, Bulgaria

Location

University Hospital "Saint Naum"

Sofia, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Stara Zagora

Stara Zagora, Bulgaria

Location

Burnaby Hospital Vancouver

Burnaby, Canada

Location

Clinique Neuro-Outaouais

Gatineau, Canada

Location

Recherche Sepmus, Inc.

Greenfield Park, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Canada

Location

Clinical Hospital Centar Split

Split, Croatia

Location

General Hospital Varazdin

Varaždin, Croatia

Location

Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni

Hradec Králové, Czechia

Location

Fakultni nemocnice Olomouc - Neurologicka klinika

Olomouc, Czechia

Location

Fakultni nemocnice Ostrava - Dept of Neurology

Ostrava-Poruba, Czechia

Location

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

Prague, Czechia

Location

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

Prague, Czechia

Location

Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni

Teplice, Czechia

Location

Astra Team Clinic

Tallinn, Estonia

Location

Tartu University Hospital

Tartu, Estonia

Location

Neuro NEO Oy - NEO Research

Turku, Finland

Location

Hopital Roger Salengro - CHU Lille - service de neurologie D

Lille, France

Location

CHU de Nîmes - Hôpital Carémeau - Service de Neurologie

Nîmes, France

Location

CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique

Rennes, France

Location

Ltd. Pineo Medical Ecosystem

Tbilisi, Georgia

Location

S. Khechinashvili University Clinic

Tbilisi, Georgia

Location

Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie

Düsseldorf, Germany

Location

Diakoniekrankenhaus Henriettenstiftung GgmBH

Hanover, Germany

Location

Klinik Und Poliklinik Fur Neurologie

Regensburg, Germany

Location

Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie

Rostock, Germany

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia

Bari, Italy

Location

A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I

Catania, Italy

Location

Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla

Chieti, Italy

Location

Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

Gallarate, Italy

Location

Azienda Ospadaliero Universitaria San Martino - PARENT

Genova, Italy

Location

Ospedale San Raffaele - U.O. di Neurologia

Milan, Italy

Location

Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica

Napoli, Italy

Location

Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla

Orbassano, Italy

Location

Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U

Pavia, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla

Roma, Italy

Location

Ospedale Sant'Andrea di Roma - MS Center

Rome, Italy

Location

American University of Beirut Medical Center

Beirut, Lebanon

Location

Bellevue Medical Center

Beirut, Lebanon

Location

Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic

Kaunas, Lithuania

Location

Department of Neurology, Haukeland University

Haukeland, Norway

Location

St Olavs Hospital - PARENT

Trondheim, Norway

Location

Szpital im. Mikołaja Kopernika - Neurology

Gdansk, Poland

Location

Uniwersyteckie Centrum Kliniczne - Dept of Neurology

Gdansk, Poland

Location

Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

Lublin, Poland

Location

Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology

Poznan, Poland

Location

Instytut Psychiatrii i Neurologii

Warsaw, Poland

Location

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

Lisbon, Portugal

Location

SC Sana Monitoring SRL.

Bucaresti, Romania

Location

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

Târgu Mureş, Romania

Location

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

Timișoara, Romania

Location

SAIH "Kemerovo Regional Clinical Hospital" - PARENT

Kemerovo, Russia

Location

BMI "Kursk Regional Clinical Hospital"

Kursk, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

Medis

Nizhny Novgorod, Russia

Location

RSHI"State Novosibirsk Regional Clinical Hospital"

Novosibirsk, Russia

Location

SEIHPE "Rostov State Medical University of MoH of RF"

Rostov-on-Don, Russia

Location

LLC " International Clinic MEDEM"

Saint Petersburg, Russia

Location

Pavlov First Saint Petersburg State Medical University - PARENT

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

SBIH "Leningrad Regional Clinical Hospital"

Saint Petersburg, Russia

Location

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

Samara, Russia

Location

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

Saratov, Russia

Location

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, Russia

Location

Siberian State Medical University

Tomsk, Russia

Location

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

Tyumen, Russia

Location

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

Yaroslavl, Russia

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Center Nis - Clinic of Neurology

Niš, Serbia

Location

National Cancer Center

Goyang-si, South Korea

Location

Severance Hospital, Yonsei University

Seoul, South Korea

Location

Hospital Universitario Reina Sofia

Córdoba, Spain

Location

Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia

Santa Cruz de Tenerife, Spain

Location

Sahlgrenska Sjukhuset

Gothenburg, Sweden

Location

(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques

Lausanne, Switzerland

Location

Hôpital Fattouma Bourghiba

Monastir, Tunisia

Location

Hôpital Habib Bourguiba - Service de Neurologie

Sfax, Tunisia

Location

Hopital Militaire de Tunis

Tunis, Tunisia

Location

SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis

Kharkiv, Ukraine

Location

Vinnitsa State Medical University - Neurology dept

Vinnytsia, Ukraine

Location

Nottingham University Hospital - Division of Clinical Neurology

Nottingham, United Kingdom

Location

Royal Hallamshire Hospital - Dept of Neurology

Sheffield, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37012898 RESULT

Related Links

• Trial Awareness and Transparency website
• US Medical Information website, Medical Resources

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt, Germany

service@emdgroup.com

+49 6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2019
• First Posted: May 23, 2019
• Study Start: August 15, 2019
• Primary Completion: February 27, 2021
• Study Completion: May 13, 2021
• Last Updated: October 31, 2023
• Results First Posted: May 5, 2022

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• 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
• 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.

Locations

CH (1); GB (2); CR (2); KR (2); SE (1); FI (1); BU (5); PL (5); CZ (6); GE (2); DE (4); BE (2); RU (18); AU (1); TU (3); CA (4); NO (2); ES (2); UA (2); LE (2); US (7); IT (12); PT (1); FR (3); LI (1); RO (3)