DDrare: Database of Drug Development for Rare Diseases

44. 多発血管炎性肉芽腫症
［臨床試験数：84，薬物数：88（DrugBank：22），標的遺伝子数：13，標的パスウェイ数：37］

Searched query = "Wegener granulomatosis", "Multiple vasculitis granulomatous disease", "Granulomatosis with polyangiitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0 mg Prednisone; 0 mg prednisone; 5 mg Prednisone; 5 mg prednisone; ABATACEPT; AZD7986; Abatacept; Abatacept (CTLA4-Ig); Alemtuzumab; Avacopan; Azathioprin-ratiopharm® 25 mg Filmtabletten; Azathioprine; Azathioprine 25 mg; Belimumab; Benralizumab; Biological: Benralizumab, Biological: Placebo to Mepolizumab; Biological: Mepolizumab, Biological: Placebo to Benralizumab; Blisibimod; CCX168; CYCLOPHOSPHAMIDE; Chimeric monoclonal antibody, IgG4 subtype; Corticosteroid; Corticosteroid and azathioprine; Cyclophosphamide; Cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids; Cyclophosphamidum; Cyclophosphamidum 500 mg; Endoxan; Endoxan® 500 mg; GALEN® tablet; Glucocorticoid (GC); Glucocorticoids; Glucocorticoids (GC); Glucocorticoids - Reduced Dose; Glucocorticoids - Standard Dose; Glucocorticoids [Reduced Dose]; Glucocorticoids [Standard Dose]; Gusperimus; Gusperimus + glucocorticoids; Hydroxychloroquine; IFX-1; INS1007; L04AC06; MEDI-563; MEPOLIZUMAB; MESNA; METOJECT 10 mg/ml, solution injectable en seringue pré-remplie; MabThera; MabThera®; Mepolizumab; Mesna; Metex 2,5 mg Tabletten; Methotrexate; Methotrexate 2.5 mg; Methotrexate 25 mg; NUCALA; Naltrexone; Naltrexone Hydrochloride; Nucala; Nucala 100 mg powder for solution for injection; Orencia; Other: No Plasma Exchange; PREDNISONE; Pednisone; Plaquenil - Hydroxychloroquine 200mg Film coated tablets; PredniSONE Tablets, USP; Prednisolone; Prednison acis® 20 mg; Prednison acis® 5 mg; Prednisone; Procedure: Plasma Exchange; RITUXIMAB; RO0452294/V01; RO0452294/V02; Recombinant humanized monoclonal antibody specific for human IL-5; Remission induction therapy; Reslizumab; Rituximab; Rituximab (Arm A); Rituximab (Arm B); SB-240563; SB-240563 (mepolizumab); Sulfamethoxazole; Trimethoprim; Trimethoprim Sulfamethoxazole; Vitamin D; Yellow Fever Vaccine; Yellow Fever vaccine (17D)

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	EUCTR2012-002062-13-DE (EUCTR)	14/03/2013	13/09/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera ® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
2	EUCTR2012-002062-13-GB (EUCTR)	18/01/2013	23/08/2012	A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis	A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis	granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: MabThera ® Product Code: RO0452294/V01 INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® Product Code: RO0452294/V02 INN or Proposed INN: RITUXIMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	25	Phase 2	United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom

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

EUCTR2012-002062-13-DE
(EUCTR)

14/03/2013

13/09/2012

A phase IIa, international, multicenter, open-label, uncontrolled study to evaluate the safety and pharmacokinetics of 4 x 375 mg/m2 Intravenous rituximab in pediatric patients with severe granulomatosis with polyangiitis (Wegener’s) or microscopic polyangiitis

A Phase IIa, International, Multicenter, Open-Label, UncontrolledStudy to Evaluate the Safety and Pharmacokinetics of4× 375 mg/m2 Intravenous Rituximab in Pediatric Patients withSevere Granulomatosis with Polyangiitis (Wegener’s) orMicroscopic Polyangiitis

granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis
MedDRA version: 19.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 19.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Trade Name: MabThera ®
Product Code: RO0452294/V01
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
Product Code: RO0452294/V02
INN or Proposed INN: RITUXIMAB

F. Hoffmann-La Roche Ltd.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom

EUCTR2012-002062-13-GB
(EUCTR)

18/01/2013