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	EUCTR2013-005535-24-GB (EUCTR)	07/06/2016	03/12/2015	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)	Abatacept (CTLA4-Ig) for the treatment of relapsing, non-severe, granulomatosis with polyangiitis (Wegener's) - ABROGATE	Granulomatosis with polyangiitis (GPA; Wegener's granulomatosis) MedDRA version: 19.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866 MedDRA version: 19.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept INN or Proposed INN: Abatacept	Univeristy of South Florida	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 3	United States;France;Mexico;Canada;Spain;Ireland;Australia;Germany;Switzerland;Italy;United Kingdom;Sweden
2	EUCTR2013-005535-24-IE (EUCTR)	04/05/2016	11/02/2016	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE	Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 100000004866 MedDRA version: 20.1;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]		University of South Florida	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	66	Phase 3	United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden
3	NCT02108860 (ClinicalTrials.gov)	April 2015	27/3/2014	Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)	Granulomatosis With Polyangiitis (Wegener's);Granulomatosis With Polyangiitis;Wegener's Granulomatosis;ANCA-Associated Vasculitis	Drug: Abatacept;Drug: placebo	University of South Florida	The Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Recruiting	15 Years	N/A	All	66	Phase 3	United States;Canada;Germany;Ireland;United Kingdom
4	EUCTR2013-005535-24-DE (EUCTR)		18/08/2017	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)	Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE	Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000140455 MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Orencia Product Name: Abatacept (CTLA4-Ig)	University of South Florida	NULL	NA			Female: yes Male: yes	150	Phase 3	United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;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

EUCTR2013-005535-24-GB
(EUCTR)

07/06/2016

03/12/2015

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)

Abatacept (CTLA4-Ig) for the treatment of relapsing, non-severe, granulomatosis with polyangiitis (Wegener's) - ABROGATE

Granulomatosis with polyangiitis (GPA; Wegener's granulomatosis)
MedDRA version: 19.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866
MedDRA version: 19.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
Product Name: Abatacept
INN or Proposed INN: Abatacept

Univeristy of South Florida

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 3

United States;France;Mexico;Canada;Spain;Ireland;Australia;Germany;Switzerland;Italy;United Kingdom;Sweden

EUCTR2013-005535-24-IE
(EUCTR)

04/05/2016

11/02/2016

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE

Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s)
MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866
MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 100000004866
MedDRA version: 20.1;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

University of South Florida

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 3

United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden

NCT02108860
(ClinicalTrials.gov)

April 2015

27/3/2014

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's)

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE)

Granulomatosis With Polyangiitis (Wegener's);Granulomatosis With Polyangiitis;Wegener's Granulomatosis;ANCA-Associated Vasculitis

Drug: Abatacept;Drug: placebo

University of South Florida

The Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Recruiting

15 Years

N/A

All

Phase 3

United States;Canada;Germany;Ireland;United Kingdom

EUCTR2013-005535-24-DE
(EUCTR)

18/08/2017

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE)

Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE

Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s)
MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000140455
MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Trade Name: Orencia
Product Name: Abatacept (CTLA4-Ig)

University of South Florida

NULL

Female: yes
Male: yes

150

Phase 3

United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden