DDrare: Database of Drug Development for Rare Diseases

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-IT (EUCTR)	28/01/2013	11/01/2013	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, 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	granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1;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 ® INN or Proposed INN: RITUXIMAB Trade Name: MabThera ® INN or Proposed INN: RITUXIMAB	F. HOFFMANN - LA ROCHE LTD.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	25	Phase 2A	United States;Turkey;United Kingdom;Italy
3	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
4	NCT01613599 (ClinicalTrials.gov)	June 20, 2012	4/6/2012	An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis	Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab	Granulomatosis With Polyangiitis;Microscopic Polyangiitis	Drug: Rituximab	Genentech, Inc.	NULL	Completed	18 Years	N/A	All	100		United States

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-IT
(EUCTR)

28/01/2013

11/01/2013

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

granulomatosis with polyangiitis (Wegener's) and microscopic polyangiitis
MedDRA version: 14.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1;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 ®
INN or Proposed INN: RITUXIMAB
Trade Name: MabThera ®
INN or Proposed INN: RITUXIMAB

F. HOFFMANN - LA ROCHE LTD.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 2A

United States;Turkey;United Kingdom;Italy

EUCTR2012-002062-13-GB
(EUCTR)

18/01/2013

23/08/2012

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

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

NCT01613599
(ClinicalTrials.gov)

June 20, 2012

4/6/2012

An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis

Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab

Granulomatosis With Polyangiitis;Microscopic Polyangiitis

Drug: Rituximab

Genentech, Inc.

NULL

Completed

18 Years

N/A

All

100

United States