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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000069-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data Collection | Other | No study treatment was administered as part of this study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MS Center of Atlanta | Atlanta | Georgia | 30327 | United States | ||
| Rush University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37012898 | Result | 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. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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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
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
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.
A total of 662 subjects were enrolled in this trial at different sites in United States and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 3, 2020 | Feb 22, 2022 |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Maryland, Baltimore - Maryland Center for MS | Baltimore | Maryland | 21201 | United States |
| Empire Neurology, PC - Empire Neurology PC | Latham | New York | 12110 | United States |
| Sanford Neuro Health Center - Neurology | Fargo | North Dakota | 58103 | United States |
| OMRF | Oklahoma City | Oklahoma | 73104 | United States |
| Rowan University School of Osteopathic Medicine - Department of Medicine | Philadelphia | Pennsylvania | 19106 | 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 | Naples | 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 |
| US Medical Information website, Medical Resources | View source |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of investigational medicinal product (IMP) (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP].
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of investigational medicinal product (IMP) (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participant | 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) |
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| Secondary | 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". | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. | Posted | Number | 95% Confidence Interval | percentage of participant | 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) |
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| Secondary | 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. | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | years | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Count of Participants | Participants | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | score on a scale | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | FAS included all participants participating in CLASSIC study [randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP]. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | Relapses | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | lesions | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | lesions | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | cubic centimeter (cm^3) | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | cubic centimeter (cm^3) | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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| Secondary | 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. | The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" refers to number of participants evaluable for specified categories. | Posted | Mean | Standard Deviation | cubic centimeter (cm^3) | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) |
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Up to study visit 2 (Up to approximately 6 months and Retrospective AEs data collection based on chart review of participants from end of parent studies; NCT00213135, NCT00641537 and NCT00725985)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A | 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. | 0 | 662 | 1 | 662 | 8 | 662 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 23.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 23.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 23.1 | Non-systematic Assessment |
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| Autoimmune thyroid disorder | Endocrine disorders | MedDRA version 23.1 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA version 23.1 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA version 23.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt, Germany | +49 6151-72-5200 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 10, 2020 | Feb 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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