DDrare: Database of Drug Development for Rare Diseases

Benlysta 400mg polvere per concentrato per soluzione per infusione (DrugBank: -)

告示番号	疾患名（ページ内リンク）	臨床試験数
43	顕微鏡的多発血管炎	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	EUCTR2011-004569-33-IT (EUCTR)	15/02/2013	14/01/2013	Belimumab in Remission of Vasculitis	A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis - BREVAS	Wegener's granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis MedDRA version: 15.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 15.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Benlysta 400mg polvere per concentrato per soluzione per infusione INN or Proposed INN: BELIMUMAB	HUMAN GENOME SCIENCES INC	NULL	Not Recruiting			Female: yes Male: yes	400	Phase 3	United States;Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;India;Hungary;Czech Republic;Mexico;European Union;Canada;Poland;Belgium;Peru;Australia;Germany;Sweden

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

EUCTR2011-004569-33-IT
(EUCTR)

15/02/2013

14/01/2013

Belimumab in Remission of Vasculitis

A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis - BREVAS

Wegener's granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
MedDRA version: 15.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Benlysta 400mg polvere per concentrato per soluzione per infusione
INN or Proposed INN: BELIMUMAB

HUMAN GENOME SCIENCES INC

NULL

Not Recruiting

Female: yes
Male: yes

400

Phase 3

United States;Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;India;Hungary;Czech Republic;Mexico;European Union;Canada;Poland;Belgium;Peru;Australia;Germany;Sweden