DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
13	多発性硬化症／視神経脊髄炎	1

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-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	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 3	United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of

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

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

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of