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 | EUCTR2015-005431-41-RO (EUCTR) | 07/12/2016 | 22/06/2016 | A late stage clinical trial to investigate the efficacy and safety of SA237 monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of SA237 as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Sapelizumab (p-INN) Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | United States;Canada;Poland;Ukraine;Croatia;Turkey;Romania;Russian Federation;Bulgaria;Italy;Korea, Republic of | ||
| 2 | EUCTR2013-003752-21-ES (EUCTR) | 07/05/2015 | 11/03/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 17.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;United States;Hungary;Taiwan;Poland;Spain;Germany;Japan;Italy;United Kingdom | ||
| 3 | EUCTR2013-003752-21-HU (EUCTR) | 04/05/2015 | 25/02/2015 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 18.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: Fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;France;Taiwan;Hungary;Spain;Poland;Germany;United Kingdom;Japan;Italy | ||
| 4 | EUCTR2013-003752-21-IT (EUCTR) | 28/03/2014 | 06/02/2014 | A late stage clinical trial to investigate the efficacy and safety of SA237 in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder | A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of SA237 in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD) | Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD) MedDRA version: 16.1;Level: PT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SA237 INN or Proposed INN: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody Other descriptive name: fully humanized anti-human IL-6 receptor (IL-6R) neutralizing monoclonal antibody | Chugai Pharmaceutical Co. Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | France;Hungary;Taiwan;Spain;Poland;Germany;United Kingdom;Japan;Italy |