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
| 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 | NCT04316494 (ClinicalTrials.gov) | December 17, 2020 | 25/2/2020 | Hydroxychloroquine in ANCA Vasculitis Evaluation | Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial | ANCA Associated Vasculitis;Microscopic Polyangiitis;Churg-Strauss Syndrome;Wegener Granulomatosis | Drug: Hydroxychloroquine;Drug: Placebo | Guy's and St Thomas' NHS Foundation Trust | Medical Research Council | Recruiting | 18 Years | N/A | All | 76 | Phase 4 | United Kingdom |
| 2 | NCT03920722 (ClinicalTrials.gov) | October 24, 2020 | 18/2/2019 | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | Efficacy and Safety of Rituximab in the Treatment of Good Prognosis Microscopic Polyangiitis | Microscopic Polyangiitis (MPA) | Drug: Rituximab;Drug: placebo | Assistance Publique - Hôpitaux de Paris | French Vasculitis Study Group | Recruiting | 18 Years | N/A | All | 106 | Phase 3 | France |
| 3 | NCT04280601 (ClinicalTrials.gov) | August 1, 2020 | 18/2/2020 | PRagmatic Analysis of Vitamin D in ANCA-Associated Vasculitis | A Local Interventional Study in a Cohort of Patients With GPA, MPA and EGPA (PART 2 of Vitamin D Status in ANCA-associated Vasculitis: Analysis of RDCRN-VCRC and Local Clinic Cohorts of Patients With GPA, MPA and EGPA) | ANCA-associated Vasculitis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Eosinophilic Granulomatosis With Polyangiitis | Dietary Supplement: vitamin D | Christian Pagnoux | NULL | Active, not recruiting | 18 Years | N/A | All | 100 | N/A | Canada |
| 4 | EUCTR2018-001268-40-GB (EUCTR) | 23/01/2020 | 13/09/2019 | Hydroxychloroquine in ANCA vasculitis | Hydroxychloroquine in ANCA Vasculitis Evaluation - A Multicentre, Randomised, Double-blind, Placebo-controlled Trial - HAVEN | The term ANCA-associated vasculitis (AAV) describes a subset of primary small vessel vasculitides characterized by the presence of anti-neutrophil cytoplasmic antibodies (ANCA): Granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). AAV are serious multisystem autoimmune disorders that can affect any organ in the body and commonly involve the ear-nose-throat, lungs, kidneys, eyes and joints MedDRA version: 20.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Plaquenil - Hydroxychloroquine 200mg Film coated tablets | Guy's and St. Thomas' NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 76 | Phase 4 | United Kingdom | ||
| 5 | EUCTR2018-000768-27-DK (EUCTR) | 05/08/2019 | 20/03/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2018-000768-27-GB (EUCTR) | 17/04/2019 | 27/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - InflaRx GmbH_IFX-1-P2.5 | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: PredniSONE Tablets, USP INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 81 | Phase 2 | Spain;Ireland;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 7 | EUCTR2018-000768-27-BE (EUCTR) | 04/04/2019 | 01/05/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Spain;Belgium;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 8 | NCT03895801 (ClinicalTrials.gov) | April 3, 2019 | 8/3/2019 | Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. | A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) | Granulomatosis With Polyangiitis (GPA);Microscopic Polyangiitis (MPA) | Drug: IFX-1;Drug: Placebo-IFX-1;Drug: Glucocorticoid (GC);Drug: Placebo-Glucocorticoid (Placebo-GC) | InflaRx GmbH | NULL | Completed | 18 Years | N/A | All | 57 | Phase 2 | Belgium;Czechia;France;Germany;Italy;Netherlands;Russian Federation;Spain;Sweden;Switzerland;United Kingdom;Denmark |
| 9 | EUCTR2018-000637-12-FR (EUCTR) | 29/03/2019 | 31/01/2019 | Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis | Efficacy and safety of rituximab in the treatment of good prognosis microscopic polyangiitis - RITUXGOPRO | Patients with newly diagnosed or relapsing MPA, without any poor prognosis marker (FFS=0). Stratification will be made according to peripheral nerve involvement. MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RIXATHON 500mg | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 106 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 10 | EUCTR2018-000768-27-DE (EUCTR) | 11/03/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 11 | EUCTR2018-000768-27-NL (EUCTR) | 10/03/2019 | 20/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | France;Czechia;Czech Republic;Spain;Belgium;Denmark;Russian Federation;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 12 | EUCTR2018-000768-27-IT (EUCTR) | 27/02/2019 | 24/05/2021 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) - Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients wit | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) Product Code: [Glucocorticoids (GC)] INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Product Name: IFX-1 Product Code: [IFX-1] INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | Czechia;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 13 | EUCTR2018-000768-27-SE (EUCTR) | 08/02/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Spain;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Czechia;Sweden | ||
| 14 | NCT03482479 (ClinicalTrials.gov) | February 4, 2019 | 22/3/2018 | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Low Dose Naltrexone to Improve Physical Health in Patients With Vasculitis | Eosinophilic Granulomatosis With Polyangiitis (EGPA);Churg-Strauss Syndrome (CSS);Giant Cell Arteritis;Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Polyarteritis Nodosa;Takayasu Arteritis | Drug: Naltrexone Hydrochloride;Other: Placebo Comparator | University of Pennsylvania | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 15 | EUCTR2018-000768-27-ES (EUCTR) | 17/01/2019 | 18/01/2019 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 20.0;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: not yet available Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE Trade Name: GALEN® tablet Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 81 | Phase 2 | France;Czech Republic;Belgium;Spain;Ireland;Denmark;Russian Federation;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 16 | EUCTR2018-000768-27-CZ (EUCTR) | 10/01/2019 | 19/12/2018 | Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases. | A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA) | Active Granulomatosis with Polyangiitis (Wegener’s) (GPA) and Microscopic Polyangiitis (MPA) MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IFX-1 INN or Proposed INN: Vilobelimab Other descriptive name: chimeric monoclonal antibody, IgG4 subtype Trade Name: PredniSONE Tablets, USP Product Name: Glucocorticoids (GC) INN or Proposed INN: PREDNISONE | InflaRx GmbH | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | Sweden;Italy;United Kingdom;Germany;Netherlands;Russian Federation;Denmark;Belgium;Spain;Czech Republic;Czechia;France | ||
| 17 | NCT03712345 (ClinicalTrials.gov) | October 15, 2018 | 16/10/2018 | Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) | Granulomatosis With Polyangiitis (GPA);Microscopic Polyangiitis (MPA) | Drug: IFX-1;Drug: Placebo | InflaRx GmbH | Iqvia Pty Ltd | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States;Canada |
| 18 | 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 |
| 19 | 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 |
| 20 | EUCTR2016-001121-14-NO (EUCTR) | 06/10/2017 | 07/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Norway;New Zealand;Sweden | ||
| 21 | EUCTR2016-001121-14-NL (EUCTR) | 15/06/2017 | 18/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 22 | EUCTR2016-001121-14-BE (EUCTR) | 08/05/2017 | 06/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 23 | EUCTR2016-001121-14-IT (EUCTR) | 04/05/2017 | 07/01/2021 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCAAssociated Vasculitis (AAV). | Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;Classification code 10050894;Term: Anti-neutrophil cytoplasmic antibody positive vasculitis;System Organ Class: 10021428 - Immune system disorders MedDRA version: 21.1;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Trade Name: Prednison acis¿ 5 mg Product Name: Prednisone INN or Proposed INN: PREDNISONE Trade Name: Prednison acis¿ 20 mg | CHEMOCENTRYX, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Czechia;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 24 | EUCTR2016-001121-14-HU (EUCTR) | 24/04/2017 | 23/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 25 | EUCTR2016-001121-14-DK (EUCTR) | 07/04/2017 | 01/02/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Denmark;Australia;Norway;Germany;Netherlands;New Zealand;Sweden | ||
| 26 | EUCTR2016-001121-14-GB (EUCTR) | 06/04/2017 | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;New Zealand;Sweden | ||
| 27 | EUCTR2016-001121-14-ES (EUCTR) | 21/03/2017 | 20/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 19.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 19.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Sweden;New Zealand;Germany;Netherlands;Norway;Denmark;Australia;Belgium;Canada;Czech Republic;Hungary;France;United Kingdom;Switzerland;Italy;Austria;Ireland;Spain;United States | ||
| 28 | EUCTR2016-001121-14-CZ (EUCTR) | 20/03/2017 | 12/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 29 | EUCTR2016-001121-14-AT (EUCTR) | 13/02/2017 | 10/01/2017 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 30 | EUCTR2016-001121-14-SE (EUCTR) | 13/02/2017 | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 31 | NCT02115997 (ClinicalTrials.gov) | July 6, 2015 | 14/4/2014 | A Study Evaluating the Safety and Efficacy of Rituximab in Combination With Glucocorticoids in Participants With Wegener's Granulomatosis or Microscopic Polyangitis | Wegener's Granulomatosis or Microscopic Polyangiitis | Drug: Methylprednisolone;Drug: Prednisone;Drug: Rituximab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 30 | Phase 4 | India | |
| 32 | EUCTR2015-001807-29-FR (EUCTR) | 09/06/2015 | 23/07/2015 | Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis | Pharmacokinetic study of rituximab induction regimen in ANCA-associated vasculitis : a predictive factor of clinical outcome? (MONITUX) - A multicentric study - MONITUX | Granulomatosis with polyangiitis Microscopic polyangiitis MedDRA version: 18.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 18.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Rituximab Product Name: Rituximab | CHU de Saint-Etienne | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 4 | France | ||
| 33 | 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 | ||
| 34 | NCT01598857 (ClinicalTrials.gov) | December 2014 | 11/5/2012 | BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis | A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Blisibimod;Drug: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | NULL |
| 35 | 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 | ||
| 36 | NCT02198248 (ClinicalTrials.gov) | October 2014 | 18/7/2014 | Low-dose Glucocorticoid Vasculitis Induction Study | Low-dose Glucocorticoids Plus Rituximab Versus High-dose Glucocorticoids Plus Rituximab for Remission Induction in ANCA-associated Vasculitis; a Multicentre, Open Label, Randomised Control Trial | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis;Microscopic Polyangiitis;Wegener Granulomatosis | Drug: Rituximab;Drug: Glucocorticoids | Chiba University | NULL | Active, not recruiting | 20 Years | N/A | All | 140 | Phase 4 | Japan |
| 37 | 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 | ||
| 38 | 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 |
| 39 | NCT02169219 (ClinicalTrials.gov) | June 2014 | 19/6/2014 | Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis | Short-Course Glucocorticoids and Rituximab in ANCA-Associated Vasculitis | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Glucocorticoids;Drug: Rituximab | Massachusetts General Hospital | Genentech, Inc. | Completed | 18 Years | 85 Years | All | 20 | Phase 4 | United States |
| 40 | JPRN-JapicCTI-132394 | 07/3/2014 | 25/12/2013 | Phase 3 study of GGS in patients with microscopic polyangiitis (MPA) | Randomized, placebo-controlled, double-blind, parallel-group clinical study of GGS in patients with microscopic polyangiitis (MPA) (Phase 3 study) | Microscopic polyangiitis (MPA) | Intervention name : Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS) INN of the intervention : - Dosage And administration of the intervention : Intravenous drip infusion Control intervention name : Placebo (physiological saline) INN of the control intervention : - Dosage And administration of the control intervention : Intravenous drip infusion | TEIJIN PHARMA LIMITED | NULL | complete | 20 | BOTH | 36 | Phase 3 | Japan | |
| 41 | JPRN-UMIN000012072 | 2013/12/01 | 01/12/2013 | A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis | Microscopic polyangiitis | Tocilizumab group | Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 20 | Phase 3 | Japan | |
| 42 | EUCTR2011-004569-33-PL (EUCTR) | 12/09/2013 | 01/07/2013 | Belimumab in Remission of Vasculitis | A 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) | 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 | ||
| 43 | JPRN-UMIN000011244 | 2013/09/01 | 01/09/2013 | A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis | Microscopic polyangiitis | Tocilizumab group Cyclophosphamide group | Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical Immunology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan | |
| 44 | JPRN-UMIN000011242 | 2013/09/01 | 01/09/2013 | Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis | Microscopic polyangiitis | tocilizumab monotherapy | Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical Immunology | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan | |
| 45 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 190 | New Zealand;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Mexico;Canada;Poland;Australia;Denmark;Netherlands;Sweden;Germany | |||
| 46 | NCT01750697 (ClinicalTrials.gov) | May 23, 2013 | 13/12/2012 | A Phase IIa Study of Intravenous Rituximab in Pediatric Participants With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | A Phase IIA, International, Multicenter, Open-label, Uncontrolled Study to Evaluate The Safety And Pharmacokinetics of 4 × 375 mg/m2 Intravenous Rituximab in Pediatric Patients With Severe Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | Granulomatosis With Polyangiitis | Drug: Rituximab | Hoffmann-La Roche | NULL | Completed | 2 Years | 17 Years | All | 25 | Phase 2 | United States;Canada;France;Germany;Italy;Serbia;Turkey;United Kingdom |
| 47 | 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 | ||
| 48 | 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 |
| 49 | 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 |
| 50 | EUCTR2012-002062-13-DE (EUCTR) | 14/03/2013 | 13/09/2012 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | Serbia;France;United States;Canada;Turkey;Germany;Italy;United Kingdom | ||
| 51 | 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 | ||
| 52 | 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 | ||
| 53 | 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 | ||
| 54 | 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 | ||
| 55 | EUCTR2012-002062-13-IT (EUCTR) | 28/01/2013 | 11/01/2013 | A 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 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Phase 2 | United States;Turkey;United Kingdom;Italy | ||
| 56 | 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 | ||
| 57 | 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 | ||
| 58 | 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 | ||
| 59 | EUCTR2012-002062-13-GB (EUCTR) | 18/01/2013 | 23/08/2012 | A 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 | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 25 | Phase 2 | United States;Serbia;France;Canada;Turkey;Germany;Italy;United Kingdom | ||
| 60 | 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 | ||
| 61 | NCT01731561 (ClinicalTrials.gov) | November 16, 2012 | 12/10/2012 | Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis | MAINtenance of Remission Using RITuximab in Systemic ANCA-associated Vasculitis II | Granulomatosis With Polyangiitis;Microscopic Polyangiitis;Renal Limited Forms | Drug: Rituximab (Arm B);Drug: Rituximab (Arm A) | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | All | 166 | Phase 3 | France |
| 62 | NCT01613599 (ClinicalTrials.gov) | June 20, 2012 | 4/6/2012 | An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis | Prospective, Observational Safety Study of Patients With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis Treated With Rituximab | Granulomatosis With Polyangiitis;Microscopic Polyangiitis | Drug: Rituximab | Genentech, Inc. | NULL | Completed | 18 Years | N/A | All | 100 | United States | |
| 63 | NCT01405807 (ClinicalTrials.gov) | February 2011 | 27/7/2011 | Alemtuzumab for ANCA Associated Refractory Vasculitis | Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy | Vasculitis;Microscopic Polyangiitis;Granulomatosis With Polyangiitis;Wegener's | Drug: Alemtuzumab | Cambridge University Hospitals NHS Foundation Trust | NULL | Recruiting | 18 Years | 60 Years | Both | 24 | Phase 4 | United Kingdom |
| 64 | NCT03919825 (ClinicalTrials.gov) | May 2010 | 15/4/2019 | Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis (PEXIVAS) - Glucocorticoids | Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial [Glucocorticoids] | Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA) | Drug: Glucocorticoids - Standard Dose;Drug: Glucocorticoids - Reduced Dose | University of Pennsylvania | NULL | Completed | 15 Years | N/A | All | 704 | Phase 3 | NULL |
| 65 | NCT00987389 (ClinicalTrials.gov) | May 2010 | 23/9/2009 | Plasma Exchange and Glucocorticoids for Treatment of Anti-Neutrophil Cytoplasm Antibody (ANCA) - Associated Vasculitis | Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomized Controlled Trial | Granulomatosis With Polyangiitis (Wegener's) (GPA);Microscopic Polyangiitis (MPA) | Procedure: Plasma Exchange;Other: No Plasma Exchange;Drug: Glucocorticoids [Standard Dose];Drug: Glucocorticoids [Reduced Dose] | University of Pennsylvania | Cambridge University Hospitals NHS Foundation Trust;University of Birmingham;National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Completed | 15 Years | N/A | All | 704 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Denmark;France;Greece;Italy;Japan;Mexico;New Zealand;Norway;Sweden;United Kingdom;Czech Republic |
| 66 | EUCTR2009-013220-24-IT (EUCTR) | 22/01/2010 | 10/12/2009 | Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVAS | Plasma exchange and glucocorticoid dosing in the treatment of ANCA-associated vasculitis: a multicentre randomized controlled tria - PEXIVAS | Acute renal severe to moderate failure with Wegener`s Granulomatosis or microscopic polyangiitis MedDRA version: 9.1;Level: HLGT;Classification code 10003816 MedDRA version: 9.1;Level: LLT;Classification code 10018378 | Trade Name: DELTACORTENE INN or Proposed INN: Prednisone Trade Name: DELTACORTENE INN or Proposed INN: Prednisone | AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 4 | Czech Republic;Poland;Spain;Denmark;United Kingdom;Italy;Sweden | ||
| 67 | 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 |
| 68 | NCT00751517 (ClinicalTrials.gov) | September 2008 | 11/9/2008 | Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides | Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial. | Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis;Polyarteritis Nodosa | Drug: Methotrexate;Drug: Cyclophosphamide | University of Parma | NULL | Active, not recruiting | 18 Years | 80 Years | Both | Phase 2 | Italy | |
| 69 | EUCTR2006-001663-33-IT (EUCTR) | 09/06/2008 | 28/05/2008 | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | ANCA-associated vasculitis (Microscopic Polyangiitis, Wegener's granulomatosis) MedDRA version: 9.1;Level: HLT;Classification code 10047113;Term: Vasculitides NEC | Trade Name: CELLCEPT INN or Proposed INN: Mycophenolic acid Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide | Vasculitis and Lupus Clinic | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Spain;Austria;Germany;United Kingdom;Italy;Sweden | |||
| 70 | EUCTR2006-001663-33-SE (EUCTR) | 13/05/2008 | 19/03/2008 | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis - MYCYC | Anti neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Wegener´s granulomatosis (WG) and microscopic polyangiitis (MPA) are primary systemic vasculitides associated with ANCA | Trade Name: Cellcept Product Name: Cellcept Product Code: Ro106-1443 INN or Proposed INN: Mycophenolate mofetil Trade Name: Sendoxan Product Name: Sendoxan Product Code: 5009111000001105 INN or Proposed INN: CYCLOPHOSPHAMIDE | Cambridge University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Czech Republic;Spain;Austria;Germany;Italy;United Kingdom;Sweden | ||
| 71 | 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 |
| 72 | EUCTR2005-003610-15-CZ (EUCTR) | 29/08/2006 | 23/02/2006 | An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS | An international, randomised, open label trial comparing a rituximab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, ‘generalised’ ANCA associated vasculitis. - RITUXVAS | The ANCA associated vasculitides (AASV), namely Wegener’s granulomatosis, microscopic polyangiitis, and renal limited vasculitis. | INN or Proposed INN: Rituximab | Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 3 | Czech Republic;United Kingdom;Sweden | ||
| 73 | 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 |
| 74 | 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 |
| 75 | NCT00103792 (ClinicalTrials.gov) | December 2004 | 14/2/2005 | Mycophenolate Mofetil for Treatment of Relapses of Wegener's Disease or Microscopic Polyangiitis (MPA) | Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-Life-Threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis | Wegener's Granulomatosis;Vasculitis | Drug: mycophenolate mofetil;Drug: cyclophosphamide | University Medical Centre Groningen | NULL | Recruiting | 18 Years | N/A | Both | 90 | Phase 3 | Netherlands |
| 76 | NCT00307593 (ClinicalTrials.gov) | May 2004 | 24/3/2006 | RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides | Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies | Wegener's Granulomatosis;Churg-Strauss Syndrome;Microscopic Polyangiitis | Drug: Infliximab;Drug: Rituximab | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 18 Years | N/A | Both | 20 | N/A | France |
| 77 | 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 |
| 78 | 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 |
| 79 | NCT00405860 (ClinicalTrials.gov) | December 2002 | 29/11/2006 | CellCept in p-ANCA Vasculitis | A Pilot Study of Mycophenolate Mofetil (MMF) in Patients With p-ANCA Microscopic Polyangiitis and Mild to Moderate Renal Dysfunction. | MPO-ANCA Vasculitis;Microscopic Polyangiitis | Drug: CellCept (mycophenolate mofetil) | Mayo Clinic | Roche Pharma AG | Completed | 18 Years | N/A | Both | 18 | Phase 1 | United States |
| 80 | NCT00307658 (ClinicalTrials.gov) | March 2001 | 27/3/2006 | Intravenous Immunoglobulin After Relapse in Vasculitis | Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener’s Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial | ANCA + Vasculitides Relapsing Either Under Corticosteroid;and Immunosuppressant Therapies or After One Year;Post Treatment. | Drug: Intravenous immunoglobulins (human immunoglobulins G) | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | 18 Years | N/A | Both | 40 | Phase 3 | France |
| 81 | NCT00430105 (ClinicalTrials.gov) | February 1998 | 31/1/2007 | Pulse Versus Continuous Cyclophosphamide for Induction of Remission in ANCA-Associated Vasculitides | Randomized Trial of Intravenous Pulse Versus Oral Continuous Cyclophosphamide for Induction of Remission in Systemic ANCA-Associated Vasculitides | ANCA Associated Systemic Vasculitis;Wegener's Granulomatosis;Microscopic Polyangiitis | Drug: cyclophosphamide | Cambridge University Hospitals NHS Foundation Trust | NULL | Completed | 18 Years | 80 Years | Both | 160 | Phase 2/Phase 3 | NULL |
| 82 | 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 |
| 83 | NCT01408836 (ClinicalTrials.gov) | March 1995 | 2/8/2011 | Plasma Exchange for Renal Vasculitis | Randomised Trial of Plasma Exchange or High Dose Methyl Prednisolone as Adjunctive Therapy for Severe Renal Vasculitis | Wegener's Granulomatosis;Microscopic Polyangiitis | Procedure: Plasma exchange;Drug: Intravenous methyl prednisolone;Drug: Methyl prednisolone | Cambridge University Hospitals NHS Foundation Trust | University Hospital Birmingham;Imperial College London;London North West Healthcare NHS Trust;University Hospitals, Leicester;Lund University Hospital;University Medical Centre Groningen;Fundacio Clinic;Helsinki University | Terminated | 18 Years | 80 Years | Both | 150 | Phase 2/Phase 3 | United Kingdom |
| 84 | 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 | |||
| 85 | EUCTR2016-001121-14-IE (EUCTR) | 21/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 86 | EUCTR2016-001121-14-DE (EUCTR) | 23/12/2016 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 21.1;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 21.1;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | |||
| 87 | EUCTR2016-001121-14-FR (EUCTR) | 22/06/2018 | A Clinical Trial to Evaluate the Safety and Efficacy of CCX168 (Avacopan), a new drug for the treatment of Vasculitis of a certain type, called ANCA-Associated Vasculitis (AAV). | A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine | Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis MedDRA version: 20.0;Level: PT;Classification code 10072579;Term: Granulomatosis with polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.0;Classification code 10063344;Term: Microscopic polyangiitis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 20.1;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] | Product Name: Avacopan Product Code: CCX168 INN or Proposed INN: Avacopan Other descriptive name: CCX168 Trade Name: Prednison acis® 5 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE Trade Name: Prednison acis® 20 mg INN or Proposed INN: Pednisone Other descriptive name: PREDNISONE | ChemoCentryx, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden |