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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2010-024477-39-ES (EUCTR) | 22/08/2011 | 28/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Interferon Beta 1a pegilado Product Code: BIIB017 INN or Proposed INN: Interferón beta 1a Other descriptive name: Interferón beta 1a pegilado | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | United States;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand | |||
| 2 | EUCTR2009-012500-11-ES (EUCTR) | 24/06/2010 | 12/04/2010 | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Esclerosis Múltiple recidivante-remitente MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | ||
| 3 | EUCTR2009-015556-15-ES (EUCTR) | 24/05/2010 | 24/03/2010 | Estudio 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 | Estudio 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece |