Abatacept (CTLA4-Ig) ( DrugBank: Abatacept )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
44多発血管炎性肉芽腫症4

44. 多発血管炎性肉芽腫症


臨床試験数 : 92 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78
No.TrialIDDate_
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PhaseCountries
1EUCTR2013-005535-24-GB
(EUCTR)
07/06/201603/12/2015Abatacept (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 FloridaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Mexico;Canada;Spain;Ireland;Australia;Germany;Switzerland;Italy;United Kingdom;Sweden
2EUCTR2013-005535-24-IE
(EUCTR)
04/05/201611/02/2016Abatacept (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]
Trade Name: Orencia
Product Name: Abatacept (CTLA4-Ig)
INN or Proposed INN: ABATACEPT
University of South FloridaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 3United States;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Belgium;Australia;Germany;Sweden
3NCT02108860
(ClinicalTrials.gov)
April 201527/3/2014Abatacept 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 VasculitisDrug: Abatacept;Drug: placeboUniversity of South FloridaThe Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Recruiting15 YearsN/AAll66Phase 3United States;Canada;Germany;Ireland;United Kingdom
4EUCTR2013-005535-24-DE
(EUCTR)
18/08/2017Abatacept (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 FloridaNULLNAFemale: yes
Male: yes
150Phase 3United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden