43. 顕微鏡的多発血管炎 Microscopic polyangiitis Clinical trials / Disease details
臨床試験数 : 88 / 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90
| 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 | JPRN-UMIN000024574 | 2018/07/02 | 01/05/2017 | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ | Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA) | TCZ group Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. IVCY group Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. | Tokyo women's medical universityInstitute of rheumatology | Hokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University Hospital | Recruiting | 20years-old | 85years-old | Male and Female | 48 | Phase 2 | Japan |
| 2 | JPRN-JMA-IIA00325 | 01/07/2018 | 23/01/2018 | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA) | Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. . Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.. | Masayoshi Harigai | NULL | Pending | >=20 YEARS | <80 YEARS | BOTH | 48 | Phase 2 | Japan |
| 3 | EUCTR2012-001102-14-CZ (EUCTR) | 15/04/2015 | 03/01/2013 | RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis | An 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 4 | EUCTR2012-001102-14-IE (EUCTR) | 10/10/2014 | 14/08/2014 | RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis | An 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 , Ireland | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Sweden | ||
| 5 | EUCTR2012-001102-14-IT (EUCTR) | 12/09/2014 | 18/12/2013 | RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis | An 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Spain;Ireland;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden | ||
| 6 | JPRN-UMIN000012409 | 2014/06/26 | 04/12/2013 | An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis | An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis - RITAZAREM | Granulomatosis With Polyangiitis (Wegener's) Microscopic Polyangiitis | Experimental: Rituximab Maintenance. Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper. Active Comparator: Azathioprine Maintenance. Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27. | University of Miyazaki Hospital | The European Vasculitis SocietyVasculitis Clinical Research Consortium | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 190 | Phase 3 | Japan,North America,South America,Australia,Europe |
| 7 | EUCTR2012-001102-14-ES (EUCTR) | 21/06/2013 | 16/05/2013 | RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis | An 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 Trust | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 3 | Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Germany;Netherlands;New Zealand;Sweden | ||
| 8 | EUCTR2011-004569-33-SE (EUCTR) | 03/04/2013 | 07/12/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United 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 | ||
| 9 | NCT01697267 (ClinicalTrials.gov) | April 2013 | 31/8/2012 | Rituximab Vasculitis Maintenance Study | An International, Open Label, Randomised Controlled Trial Comparing Rituximab With Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis | Biological: Rituximab;Drug: Azathioprine | Cambridge University Hospitals NHS Foundation Trust | Arthritis Research UK;Roche Pharma AG;Genentech, Inc.;University of Pennsylvania | Completed | 15 Years | N/A | All | 188 | Phase 3 | United States;Australia;Canada;Czechia;Ireland;Italy;Japan;New Zealand;Sweden;United Kingdom;Czech Republic |
| 10 | NCT01663623 (ClinicalTrials.gov) | March 20, 2013 | 9/8/2012 | Belimumab in Remission of VASculitis | A 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 | Vasculitis | Biological: Placebo;Biological: Belimumab 10 mg/kg;Drug: Azathioprine | Human Genome Sciences Inc., a GSK Company | GlaxoSmithKline | Completed | 18 Years | N/A | All | 106 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Ireland;Italy;Mexico;Norway;Peru;Poland;Romania;Russian Federation;Spain;Sweden;Switzerland;United Kingdom;Austria;Brazil;Czech Republic;Finland;India |
| 11 | EUCTR2011-004569-33-DE (EUCTR) | 11/03/2013 | 15/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United 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 | ||
| 12 | EUCTR2011-004569-33-IT (EUCTR) | 15/02/2013 | 14/01/2013 | Belimumab in Remission of Vasculitis | A 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 INC | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;India;Hungary;Czech Republic;Mexico;European Union;Canada;Poland;Belgium;Peru;Australia;Germany;Sweden | ||
| 13 | EUCTR2011-004569-33-CZ (EUCTR) | 14/02/2013 | 21/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United 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 | ||
| 14 | EUCTR2011-004569-33-HU (EUCTR) | 11/02/2013 | 18/12/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United 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 | ||
| 15 | EUCTR2011-004569-33-IE (EUCTR) | 25/01/2013 | 29/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United 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 | ||
| 16 | EUCTR2011-004569-33-BE (EUCTR) | 23/01/2013 | 21/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United 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 | ||
| 17 | EUCTR2011-004569-33-ES (EUCTR) | 23/01/2013 | 26/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United 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 | ||
| 18 | EUCTR2011-004569-33-GB (EUCTR) | 20/12/2012 | 08/11/2012 | Belimumab in Remission of Vasculitis | A 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) | NULL | Not 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): no | United 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 | ||
| 19 | NCT00748644 (ClinicalTrials.gov) | October 2008 | 5/9/2008 | Efficacy Study of Two Treatments in the Remission of Vasculitis | MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis | Wegener Granulomatosis;Microscopic Polyangiitis | Drug: Rituximab;Drug: Azathioprine | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | 75 Years | All | 117 | Phase 3 | France |
| 20 | NCT00647166 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) | Evaluation of a New Treatment Strategy for Patients With Microscopic Polyangiitis, Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome) Without Poor Prognosis Factors | MPA;PAN or EGPA With FFS=0;At Diagnosis or Within the First 15 Days Following Initiation of Corticosteroids | Drug: corticosteroid and azathioprine;Drug: corticosteroid and placebo | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 114 | Phase 3 | France |
| 21 | NCT00307671 (ClinicalTrials.gov) | July 2005 | 27/3/2006 | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years | Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Polyarteritis Nodosa | Drug: prednisone, methylprednisolone,cyclophosphamides;Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone;Drug: Mycophenolate mofetil,methotrexate | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 65 Years | N/A | Both | 108 | Phase 4 | France |
| 22 | NCT00104299 (ClinicalTrials.gov) | January 2005 | 24/2/2005 | Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis | Rituximab Therapy for the Induction of Remission and Tolerance in ANCA-Associated Vasculitis (ITN021AI) | Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis | Drug: Rituximab plus cyclophosphamide placebo (rituximab group);Drug: Cyclophosphamide plus rituximab placebo (control group);Drug: Azathioprine;Drug: Methylprednisolone (or other glucocorticoid);Drug: Prednisone | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN);Genentech, Inc. | Completed | 15 Years | N/A | All | 197 | Phase 2/Phase 3 | United States;Netherlands |
| 23 | NCT00307645 (ClinicalTrials.gov) | May 2003 | 27/3/2006 | IMPROVE: Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy in ANCA Associated Systemic Vasculitis | ANCA Associated Systemic Vasculitis Including Wegener’s;Granulomatosis and Microscopic Polyangiitis and;Renal Limited Vasculitis | Drug: Cyclophosphamide;Drug: Mycophenolate mofetil;Drug: Azathioprine;Drug: Prednisone (and methylprednisolone) | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | 18 Years | N/A | Both | 160 | Phase 3 | France;United Kingdom |
| 24 | NCT00753103 (ClinicalTrials.gov) | January 2003 | 15/9/2008 | Anti-Cytokine Therapy for Vasculitis | Phase II Pilot Cohort Study to Investigate the Safety and Efficacy of Infliximab as Additional Therapy in the Treatment if Anti-Neutrophil Cytoplasm Antibody Associated Vasculitis | Wegener's Granulomatosis;Renal Limited Vasculitis;Microscopic Polyangiitis | Biological: Infliximab;Drug: Cyclophosphamide;Drug: Prednisolone;Drug: Azathioprine;Procedure: Plasma exchange;Drug: Mycophenolate mofetil;Drug: Methylprednisolone | University Hospital Birmingham NHS Foundation Trust | NULL | Completed | 18 Years | N/A | Both | 37 | Phase 2 | United Kingdom |
| 25 | NCT00400075 (ClinicalTrials.gov) | July 1996 | 14/11/2006 | CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors | CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients | Polyarteritis Nodosa;Microscopic Polyangiitis | Drug: azathioprine;Drug: cyclophosphamide | Hospices Civils de Lyon | NULL | Active, not recruiting | 15 Years | 90 Years | Both | 124 | Phase 4 | Switzerland |
| 26 | EUCTR2012-001102-14-GB (EUCTR) | 07/09/2012 | RITAZAREM: A trial of rituximab versus azathioprine for maintenance of remission in ANCA vasculitis | An 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 Trust | NULL | Not 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): no | Spain;Ireland;Austria;Italy;United Kingdom;Czech Republic;Canada;Switzerland;Mexico;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden |