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.
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
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
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
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
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
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
Canada4 sites
Burnaby Hospital Vancouver
Burnaby
Clinique Neuro-Outaouais
Gatineau
Recherche Sepmus, Inc.
Greenfield Park
The Ottawa Hospital - General Campus
Ottawa
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
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
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
Tunisia3 sites
Hôpital Fattouma Bourghiba
Monastir
Hôpital Habib Bourguiba - Service de Neurologie
Sfax
Hopital Militaire de Tunis
Tunis
Belgium2 sites
Limburgs Universitair Centrum
Hasselt
University Hospital of Liege
Seraing
Croatia2 sites
Clinical Hospital Centar Split
Split
General Hospital Varazdin
Varaždin
Georgia2 sites
Ltd. Pineo Medical Ecosystem
Tbilisi
S. Khechinashvili University Clinic
Tbilisi
Lebanon2 sites
American University of Beirut Medical Center
Beirut
Bellevue Medical Center
Beirut
Norway2 sites
Department of Neurology, Haukeland University
Haukeland
St Olavs Hospital - PARENT
Trondheim
Serbia2 sites
Clinical Center of Serbia
Belgrade
Clinical Center Nis - Clinic of Neurology
Niš
South Korea2 sites
National Cancer Center
Goyang-si
Severance Hospital, Yonsei University
Seoul
Spain2 sites
Hospital Universitario Reina Sofia
Córdoba
Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia
Santa Cruz de Tenerife
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
United Kingdom2 sites
Nottingham University Hospital - Division of Clinical Neurology
Nottingham
Royal Hallamshire Hospital - Dept of Neurology
Sheffield
Austria1 site
Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie
Linz
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic
Kaunas
Portugal1 site
Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia
Lisbon
Switzerland1 site
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
Lausanne
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).
- Conditions
- Multiple Sclerosis (MS)
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
- First posted23 May 2019
- Study start15 Aug 2019
- Primary completion27 Feb 2021
- Study completion13 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03961204
- Acronym / sponsor ID
- MS700568_0026
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple Sclerosis, Cladribine, High Disease Activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Other: Data CollectionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data CollectionNo study treatment was administered as part of this study | Other | Cohort A |
Primary outcome
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)
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.
10 secondary outcomes
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
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)
Clinical and Demographic Characteristic: Age, Disease Duration
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)
Number of Participants in Each Category of Clinical and Demographic Characteristics
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)
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
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)
Clinical Characteristic: Number of Relapses
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)
Number of Total T1-weighted (T1-W) Lesions
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Number of Total T2-weighted (T2-W) Lesions
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
T1-weighted (T1-W) Lesion Volume
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
T2-weighted (T2-W) Lesion Volume
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Total Brain Volume
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37012898Giovannoni 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.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- US Medical Information website, Medical ResourcesLink provided by the sponsor.
- Individual participant dataSharing planned: 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
Related trials for Multiple Sclerosis (MS)
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
99 sites in 29 countries: see every site and its status.
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.