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Multiple Sclerosis (MS)Phase 4NCT03961204

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

A Phase 4 study testing Data Collection in people with Multiple Sclerosis (MS), run by EMD Serono Research & Development Institute, Inc. at 99 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis (MS)
What is being tested?
Data Collection
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
662 participants
Where
99 sitesin 29 countries
Study dates
15 Aug 2019to 13 May 2021
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

99 sites in 29 countries.

99 sites in 29 countries

Russia18 sites

  • SAIH "Kemerovo Regional Clinical Hospital" - PARENT

    Kemerovo

  • BMI "Kursk Regional Clinical Hospital"

    Kursk

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

    Moscow

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

    Moscow

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

    Moscow

  • Medis

    Nizhny Novgorod

  • RSHI"State Novosibirsk Regional Clinical Hospital"

    Novosibirsk

  • SEIHPE "Rostov State Medical University of MoH of RF"

    Rostov-on-Don

  • LLC " International Clinic MEDEM"

    Saint Petersburg

  • Pavlov First Saint Petersburg State Medical University - PARENT

    Saint Petersburg

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

    Saint Petersburg

  • SBIH "Leningrad Regional Clinical Hospital"

    Saint Petersburg

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

    Samara

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

    Saratov

  • RSBIH "Smolensk Regional Clinical Hospital"

    Smolensk

  • Siberian State Medical University

    Tomsk

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

    Tyumen

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

    Yaroslavl

Other trials in Russia

Italy12 sites

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia

    Bari

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

    Catania

  • Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla

    Chieti

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

    Gallarate

  • Azienda Ospadaliero Universitaria San Martino - PARENT

    Genova

  • Ospedale San Raffaele - U.O. di Neurologia

    Milan

  • Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica

    Naples

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

    Orbassano

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

    Pavia

  • Azienda Ospedaliera San Camillo Forlanini

    Roma

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

    Roma

  • Ospedale Sant'Andrea di Roma - MS Center

    Rome

Other trials in Italy

United States7 sites

  • MS Center of Atlanta

    Atlanta, Georgia, 30327

  • University of Maryland, Baltimore - Maryland Center for MS

    Baltimore, Maryland, 21201

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Sanford Neuro Health Center - Neurology

    Fargo, North Dakota, 58103

  • Empire Neurology, PC - Empire Neurology PC

    Latham, New York, 12110

  • OMRF

    Oklahoma City, Oklahoma, 73104

  • Rowan University School of Osteopathic Medicine - Department of Medicine

    Philadelphia, Pennsylvania, 19106

Other trials in United States

Czechia6 sites

  • Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni

    Hradec Králové

  • Fakultni nemocnice Olomouc - Neurologicka klinika

    Olomouc

  • Fakultni nemocnice Ostrava - Dept of Neurology

    Ostrava-Poruba

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

    Prague

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

    Prague

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

    Teplice

Other trials in Czechia

Bulgaria5 sites

  • Military Medical Academy - MHAT - Pleven

    Pleven

  • MHAT - Shumen, AD

    Shumen

  • MHAT - "National Heart Hospital" EAD - Multiple Clinics

    Sofia

  • University Hospital "Saint Naum"

    Sofia

  • Multiprofile Hospital for Active Treatment - Stara Zagora

    Stara Zagora

Other trials in Bulgaria

Poland5 sites

  • Szpital im. Mikołaja Kopernika - Neurology

    Gdansk

  • Uniwersyteckie Centrum Kliniczne - Dept of Neurology

    Gdansk

  • Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny

    Lublin

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

    Poznan

  • Instytut Psychiatrii i Neurologii

    Warsaw

Other trials in Poland

Canada4 sites

  • Burnaby Hospital Vancouver

    Burnaby

  • Clinique Neuro-Outaouais

    Gatineau

  • Recherche Sepmus, Inc.

    Greenfield Park

  • The Ottawa Hospital - General Campus

    Ottawa

Other trials in Canada

Germany4 sites

  • Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie

    Düsseldorf

  • Diakoniekrankenhaus Henriettenstiftung GgmBH

    Hanover

  • Klinik Und Poliklinik Fur Neurologie

    Regensburg

  • Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie

    Rostock

Other trials in Germany

France3 sites

  • Hopital Roger Salengro - CHU Lille - service de neurologie D

    Lille

  • CHU de Nîmes - Hôpital Carémeau - Service de Neurologie

    Nîmes

  • CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique

    Rennes

Other trials in France

Romania3 sites

  • SC Sana Monitoring SRL.

    Bucaresti

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

    Târgu Mureş

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

    Timișoara

Other trials in Romania

Tunisia3 sites

  • Hôpital Fattouma Bourghiba

    Monastir

  • Hôpital Habib Bourguiba - Service de Neurologie

    Sfax

  • Hopital Militaire de Tunis

    Tunis

Other trials in Tunisia

Belgium2 sites

  • Limburgs Universitair Centrum

    Hasselt

  • University Hospital of Liege

    Seraing

Other trials in Belgium

Croatia2 sites

  • Clinical Hospital Centar Split

    Split

  • General Hospital Varazdin

    Varaždin

Other trials in Croatia

Estonia2 sites

  • Astra Team Clinic

    Tallinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

Georgia2 sites

  • Ltd. Pineo Medical Ecosystem

    Tbilisi

  • S. Khechinashvili University Clinic

    Tbilisi

Other trials in Georgia

Lebanon2 sites

  • American University of Beirut Medical Center

    Beirut

  • Bellevue Medical Center

    Beirut

Other trials in Lebanon

Norway2 sites

  • Department of Neurology, Haukeland University

    Haukeland

  • St Olavs Hospital - PARENT

    Trondheim

Other trials in Norway

Serbia2 sites

  • Clinical Center of Serbia

    Belgrade

  • Clinical Center Nis - Clinic of Neurology

    Niš

Other trials in Serbia

South Korea2 sites

  • National Cancer Center

    Goyang-si

  • Severance Hospital, Yonsei University

    Seoul

Other trials in South Korea

Spain2 sites

  • Hospital Universitario Reina Sofia

    Córdoba

  • Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia

    Santa Cruz de Tenerife

Other trials in Spain

Ukraine2 sites

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

    Kharkiv

  • Vinnitsa State Medical University - Neurology dept

    Vinnytsia

Other trials in Ukraine

United Kingdom2 sites

  • Nottingham University Hospital - Division of Clinical Neurology

    Nottingham

  • Royal Hallamshire Hospital - Dept of Neurology

    Sheffield

Other trials in United Kingdom

Australia1 site

  • University of Sydney

    Camperdown

Other trials in Australia

Austria1 site

  • Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie

    Linz

Other trials in Austria

Finland1 site

  • Neuro NEO Oy - NEO Research

    Turku

Other trials in Finland

Lithuania1 site

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

    Kaunas

Other trials in Lithuania

Portugal1 site

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

    Lisbon

Other trials in Portugal

Sweden1 site

  • Sahlgrenska Sjukhuset

    Gothenburg

Other trials in Sweden

Switzerland1 site

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

    Lausanne

Other trials in Switzerland

About this study

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)

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).

Being tested
Data Collection
Keywords
Multiple Sclerosis, Cladribine, High Disease Activity
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data CollectionOther

    No study treatment was administered as part of this study

Study groups in NCT03961204
Study groupRoleWhat they receive
Cohort AOtherThe 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.
Receives: Other: Data Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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".

    Measured: 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)

  2. 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.

    Measured: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  3. 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.

    Measured: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  4. 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.

    Measured: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  5. 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.

    Measured: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  6. 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.

    Measured: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  7. 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.

    Measured: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  8. 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.

    Measured: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  9. 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.

    Measured: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  10. 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.

    Measured: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start15 Aug 2019
  3. Primary completion27 Feb 2021
  4. Study completion13 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
662 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961204
Sponsor's protocol ID
MS700568_0026
Other IDs
2019-000069-19, 2019
Status last verified
Oct 2023
First submitted
22 May 2019
Last updated
31 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • 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.

    PubMed 37012898

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Data Collection in people with Multiple Sclerosis (MS), run by EMD Serono Research & Development Institute, Inc. at 99 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in Russia, Italy, United States, Czechia, Bulgaria and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961204, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.

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