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

  
7 trials found
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PhaseCountries
1EUCTR2020-004505-32-IT
(EUCTR)
24/09/202112/10/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mgSC monthly vs. First Line DMT - physician’s choice in the treatment of newly diagnosed RMS (STHENOS) - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE 28 SIRINGHE PRERIEMPITE
Product Name: COPAXONE
Product Code: [-]
INN or Proposed INN: glatiramer acetato
Trade Name: Rebif
Product Name: Rebif
Product Code: [-]
INN or Proposed INN: interferone beta-1a
Trade Name: Rebif
Product Name: rebif
Product Code: [-]
INN or Proposed INN: interferone beta-1a
Trade Name: plegridy
Product Name: plegridy
Product Code: [-]
INN or Proposed INN: peginterferone beta 1a
Trade Name: Avonex
Product Name: Avonex
Product Code: [-]
INN or Proposed INN: Interferone beta 1a
Trade Name: Extavia
Product Name: Extavia
Product Code: [-]
INN or Proposed INN: interferone beta-1b
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN
NOVARTIS PHARMA AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Spain;Germany;Italy
2EUCTR2016-004819-12-IT
(EUCTR)
10/01/201820/01/2022Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patientsDiscontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders Relapsing-Remitting multiple sclerosis (RR-MS),
MedDRA version: 21.1;Level: PT;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: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML
Product Name: Interferone Beta-1B
Product Code: [032166011]
INN or Proposed INN: INTERFERONE BETA 1B
Other descriptive name: Interferon Beta-1B
Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE
Product Name: Inteferone Beta-1A
Product Code: [033283045]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta 1-A
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
Product Name: Glatiramer acetato
Product Code: [035418060]
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: Glatiramer acetate
Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE
Product Name: Interferon Beta-1a
Product Code: [034091165]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta-1a
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4Italy
3EUCTR2015-000922-12-IT
(EUCTR)
05/11/201528/02/2018A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;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: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INCNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
4EUCTR2009-015556-15-ES
(EUCTR)
24/05/201024/03/2010Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSEstudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: TYSABRI 300 mg concentrado para solución para perfusión
INN or Proposed INN: NATALIZUMAB
Other descriptive name: NATALIZUMAB
Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: GLATIRAMER ACETATE
Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
5EUCTR2006-003697-10-ES
(EUCTR)
29/08/200728/02/2007A Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/AA Randomized, Multicenter, Placebo-Controlled and Active Reference (Glatiramer Acetate) Comparison Study to Evaluate the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple SclerosisEstudio aleatorizado, multicéntrico, controlado con placebo y de comparación con un fármaco activo de referencia (glatiramer acetato) para evaluar la eficacia y la seguridad de BG00012 en pacientes con esclerosis múltiple recidivante-remitente - N/A Relapsing-Remitting Multiple SclerosisEsclerosis Múltiple recidivante-remitente
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: BG00012
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Copaxone
Product Name: Copaxone
Other descriptive name: glatiramer acetate
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1232Phase 3Estonia;Czech Republic;Greece;Belgium;Spain;Ireland;Bulgaria;Germany;Latvia
6EUCTR2006-002037-20-ES
(EUCTR)
06/09/200607/07/2006 A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1;Level: PT;Classification code 10028245
Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetato
Trade Name: Copaxone 20 mg/ml solución para inyección en jeringa precargada
Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: Copaxone
Teva Pharmaceutical Industries, Ltd.NULLNot Recruiting Female: yes
Male: yes
980 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Czech Republic;Hungary;Finland;Belgium;Spain;Lithuania;Germany;Latvia;Italy;United Kingdom
7EUCTR2006-002037-20-IT
(EUCTR)
12/07/200630/08/2006A Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTEA Multinational, Multicenter, Randomized, Parallel-Group, Double-Blind, Study, to Compare the Efficacy, Tolerability and Safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml Administered Once Daily by Subcutaneous Injection in Subjects with Relapsing Remitting R-R Multiple Sclerosis MS . - FORTE Patients with Relapsing - Remitting Multiple Sclerosis.
MedDRA version: 6.1;Level: PT;Classification code 10028245
Product Name: 40 mg Glatiramer acetato
Product Code: 40 mg GA
INN or Proposed INN: Glatiramer acetate
Trade Name: COPAXONE*SC 28SIR 20MG/ML
INN or Proposed INN: Glatiramer acetate
Teva Pharmaceuticals Industries Ltd.NULLNot RecruitingFemale: yes
Male: yes
980Hungary;Germany;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Italy;Latvia;Lithuania