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 | EUCTR2011-006262-40-GB (EUCTR) | 24/09/2013 | 03/07/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 2 | EUCTR2011-006262-40-NL (EUCTR) | 03/07/2013 | 10/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: PRD806998 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 3 | EUCTR2011-006262-40-CZ (EUCTR) | 18/06/2013 | 05/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 4 | EUCTR2011-006262-40-HU (EUCTR) | 06/06/2013 | 25/04/2013 | A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 INN or Proposed INN: Not available Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom | ||
| 5 | EUCTR2011-006262-40-IT (EUCTR) | 01/06/2013 | 08/04/2013 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® | Relapsing forms of multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: BIIB033 Product Code: BIIB033 Other descriptive name: Human anti-LINGO-1 monoclonal antibody Trade Name: Avonex Product Name: AVONEX INN or Proposed INN: Interferon beta-1a | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 396 | Phase 2 | United States;Serbia;Hungary;Czech Republic;Canada;Spain;Russian Federation;Netherlands;United Kingdom;Italy |