43. 顕微鏡的多発血管炎 Microscopic polyangiitis Clinical trials / Disease details


臨床試験数 : 87 薬物数 : 84 - (DrugBank : 20) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 88

  
9 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2012-001102-14-CZ
(EUCTR)
15/04/201503/01/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study ANCA vasculitis.
MedDRA version: 18.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;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: MabThera® 500MG
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate Mofetil
Product Name: Mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Trade Name: MabThera® 100MG
INN or Proposed INN: RITUXIMAB
Cambridge University Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden
2EUCTR2012-001102-14-IE
(EUCTR)
10/10/201414/08/2014RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study ANCA vasculitis.
MedDRA version: 18.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;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: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate
Product Name: Mycophenolate
INN or Proposed INN: Mycophenolic acid
University College Cork , IrelandNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden
3EUCTR2012-001102-14-IT
(EUCTR)
12/09/201418/12/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study ANCA vasculitis.
MedDRA version: 16.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;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: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate Mofetil
Product Name: Mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Cambridge University Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
4EUCTR2012-001102-14-ES
(EUCTR)
21/06/201316/05/2013RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study ANCA vasculitis.
MedDRA version: 16.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;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: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Cambridge University Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190New Zealand;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Sweden;Germany
5EUCTR2012-002062-13-DE
(EUCTR)
14/03/201313/09/2012A 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 polyangiitisA 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom
6EUCTR2012-002062-13-IT
(EUCTR)
28/01/201311/01/2013A 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 POLYANGIITISA 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
25Phase 2United States;Turkey;United Kingdom;Italy
7EUCTR2012-002062-13-GB
(EUCTR)
18/01/201323/08/2012A 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 polyangiitisA 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.NULLNot RecruitingFemale: yes
Male: yes
25Phase 2United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom
8NCT01613599
(ClinicalTrials.gov)
June 20, 20124/6/2012An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic PolyangiitisProspective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With RituximabGranulomatosis With Polyangiitis;Microscopic PolyangiitisDrug: RituximabGenentech, Inc.NULLCompleted18 YearsN/AAll100United States
9EUCTR2012-001102-14-GB
(EUCTR)
07/09/2012RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitisAn international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM: Rituximab vasculitis maintenance study ANCA vasculitis.
MedDRA version: 15.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;Classification code 10063344;Term: Microscopic polyangiitis;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: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Azathioprine
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Trade Name: Methotrexate
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Trade Name: Mycophenolate Mofetil
Product Name: Mycophenolate mofetil
INN or Proposed INN: Mycophenolate mofetil
Cambridge University Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Canada;Switzerland;Mexico;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden