43. Microscopic polyangiitis Clinical trials / Disease details


Clinical trials : 87 Drugs : 84 - (DrugBank : 20) / Drug target genes : 15 - Drug target pathways : 88

  
10 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2011-004569-33-PL
(EUCTR)
12/09/201301/07/2013Belimumab in Remission of VasculitisA Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluatethe Efficacy and Safety of Belimumab (HGS1006) in Combination withAzathioprine for the Maintenance of Remission in Wegener'sGranulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
2EUCTR2011-004569-33-SE
(EUCTR)
03/04/201307/12/2012Belimumab in Remission of VasculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Australia;Peru;Germany;Sweden
3EUCTR2011-004569-33-DE
(EUCTR)
11/03/201315/11/2012Belimumab in Remission of VasculitisA Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
4EUCTR2011-004569-33-IT
(EUCTR)
15/02/201314/01/2013Belimumab in Remission of VasculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener's granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
MedDRA version: 15.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 15.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400mg polvere per concentrato per soluzione per infusione
INN or Proposed INN: BELIMUMAB
HUMAN GENOME SCIENCES INCNULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;India;Hungary;Czech Republic;Mexico;European Union;Canada;Poland;Belgium;Peru;Australia;Germany;Sweden
5EUCTR2011-004569-33-CZ
(EUCTR)
14/02/201321/11/2012Belimumab in Remission of VasculitisA Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
6EUCTR2011-004569-33-HU
(EUCTR)
11/02/201318/12/2012Belimumab in Remission of VasculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Ireland;Austria;Russian Federation;United Kingdom;Italy;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Australia;Peru;Germany;Sweden
7EUCTR2011-004569-33-IE
(EUCTR)
25/01/201329/11/2012Belimumab in Remission of VasculitisA Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
8EUCTR2011-004569-33-ES
(EUCTR)
23/01/201326/11/2012Belimumab in Remission of VasculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener's Granulomatosis and Microscopic Polyangiitis. - BREVAS Wegener's granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 14.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 14.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
400Phase 3United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
9EUCTR2011-004569-33-BE
(EUCTR)
23/01/201321/11/2012Belimumab in Remission of VasculitisA Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG)Microscopic polyangiitis (MPA)Vasculitis
MedDRA version: 18.0;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 18.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;Switzerland;United Kingdom;India;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Peru;Australia;Germany;Sweden
10EUCTR2011-004569-33-GB
(EUCTR)
20/12/201208/11/2012Belimumab in Remission of VasculitisA Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Combination with Azathioprine for the Maintenance of Remission in Wegener’s Granulomatosis and Microscopic Polyangiitis - BREVAS Wegener’s granulomatosis (WG) Microscopic polyangiitis (MPA) Vasculitis
MedDRA version: 16.1;Level: LLT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders
MedDRA version: 16.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Finland;Spain;Ireland;Austria;Russian Federation;Italy;United Kingdom;Switzerland;India;France;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Australia;Peru;Germany;Sweden