13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1EUCTR2020-003995-42-IT
(EUCTR)
13/05/202104/06/2021Extension to the MAGNIFY MS trial on Mavenclad®A 2-year extension study to evaluate long-term effectiveness of Mavenclad® in participants who have completed Trial MS700568_0022 (MAGNIFY MS) - Magnify MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
261Phase 4Hungary;Czech Republic;Canada;Finland;Poland;Australia;Israel;Germany;Italy
2EUCTR2020-003874-30-IT
(EUCTR)
08/01/202124/05/2021Cognition and HRQoL in adults with highly-active RMS in Year 3 and 4 after initial Mavenclad® doseA 2-year follow-up study to assess cognition and health-related quality of life in participants with highly-active relapsing multiple sclerosis, having participated in the CLARIFY MS trial - CLARIFY MS Extension Highly-active relapsing multiple sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD - 10 MG - COMPRESSA - USO ORALE - BLISTER (AL/AL) - 6 COMPRESSE
Product Name: Cladribine tablets
Product Code: [Not Applicable]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 4France;Czechia;Hungary;Slovakia;Spain;Poland;Denmark;Austria;Netherlands;Italy
3EUCTR2019-000069-19-IT
(EUCTR)
11/10/201901/09/2021Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical TrialsEvaluating the Long-Term Outcomes and Durability of Effect Following Treatment with Cladribine Tablets for Multiple Sclerosis: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials - CLASSIC-MS Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MAVENCLAD
Product Name: Cladribina
Product Code: [Not applicable]
MERCK KGAANULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Tunisia;Latvia;Korea, Republic of;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
4EUCTR2017-002631-42-IT
(EUCTR)
16/07/201817/06/2021A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis - . Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Mavenclad
Product Code: [-]
INN or Proposed INN: CLADRIBINA
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 4Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
5EUCTR2017-002632-17-IT
(EUCTR)
03/05/201822/01/2021A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® - . Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Mavenclad
Product Code: [.]
INN or Proposed INN: CLADRIBINA
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Czechia;Slovakia;Greece;Finland;Spain;Ireland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
6EUCTR2009-017978-21-ES
(EUCTR)
13/07/201117/11/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina.
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
7EUCTR2008-003706-33-ES
(EUCTR)
29/01/200909/12/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM).
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
8EUCTR2007-000381-20-IT
(EUCTR)
29/05/200820/03/2008naVEDI ITALIANO - CLARITY EXTENTION SCLEROSI MULTIPLA A RICADUTE E REMISSIONI
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CLADRIBINA
Product Code: NA
INN or Proposed INN: Cladribine
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Estonia;Greece;Finland;Lithuania;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Bulgaria;Netherlands;Germany
9EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: not applicable
Product Name: Interferon beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy