Disease details

臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241

12 trials found

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	JPRN-JapicCTI-205119	15/10/2019	20/01/2020	A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients	A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients	neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)	Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Chugai Pharmaceutical Co., Ltd.	F. Hoffmann-La Roche Ltd	complete	12	74	BOTH	30	NA	Japan
2	EUCTR2015-005431-41-PL (EUCTR)	16/10/2017	07/04/2016	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (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 Satralizumab (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 Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
3	EUCTR2015-005431-41-HR (EUCTR)	30/11/2016	15/12/2016	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (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 Satralizumab (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 Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	12	Phase 3	United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
4	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
5	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
6	EUCTR2013-003752-21-PL (EUCTR)	31/08/2014	04/07/2014	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (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 Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO 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 Name: Satralizumab (120mg/vial) Product Code: Satralizumab (RO5333787/Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satrazlizumab (RO5333787/ Enspryng /SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	France;United States;Hungary;Taiwan;Spain;Poland;Ukraine;Germany;Japan;Italy;United Kingdom
7	NCT02073279 (ClinicalTrials.gov)	August 5, 2014	25/2/2014	Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)	Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)	Drug: Satralizumab;Drug: Placebo	Hoffmann-La Roche	Chugai Pharmaceutical	Active, not recruiting	18 Years	74 Years	All	95	Phase 3	United States;Bulgaria;Canada;Croatia;Georgia;Italy;Korea, Republic of;Malaysia;Philippines;Poland;Puerto Rico;Romania;Taiwan;Turkey;Ukraine;Bosnia and Herzegovina;Singapore
8	EUCTR2013-003752-21-DE (EUCTR)	22/05/2014	20/12/2013	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (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 Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO 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 Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche 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
9	EUCTR2013-003752-21-GB (EUCTR)	19/05/2014	15/10/2013	A late stage clinical trial to investigate the efficacy and safety of Satralizumab (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 Satralizumab (SA237) in patients with neuromyelitis optica (NMO) and NMO 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 Name: Satralizumab (120 mg/vial) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787 Product Name: Satralizumab (120 mg/PFS with NSD) Product Code: Satralizumab (RO5333787/Enspryng/SA237) INN or Proposed INN: Satralizumab (r-INN) Other descriptive name: RO5333787	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	70	Phase 3	United States;France;Taiwan;Hungary;Spain;Poland;Germany;Japan;Italy;United Kingdom
10	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
11	JPRN-JapicCTI-132397	20/2/2014	26/12/2013	Efficacy and Safety Study as Add-on Therapy of SA237 to Treat NMO and NMOSD	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 (NMOSD)	Intervention name : SA237 INN of the intervention : satralizumab Dosage And administration of the intervention : subcutaneous administration of SA237 Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	Chugai Pharmaceutical Co., Ltd.	F. Hoffmann-La Roche Ltd	complete	12	74	BOTH	85	Phase 3	Japan, Asia except Japan, North America, Europe
12	NCT02028884 (ClinicalTrials.gov)	February 20, 2014	6/1/2014	Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	A Multicenter, Randomized, Addition to Baseline Treatment, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) in Patients With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)	Neuromyelitis Optica (NMO);NMO Spectrum Disorder (NMOSD)	Drug: Satralizumab;Drug: Placebo;Drug: Baseline Treatment	Hoffmann-La Roche	Chugai Pharmaceutical	Active, not recruiting	12 Years	74 Years	All	83	Phase 3	United States;France;Germany;Hungary;Italy;Japan;Poland;Spain;Taiwan;Ukraine;United Kingdom

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