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 | 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 |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | |
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 |
| 19 | 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 | ||
| 20 | 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 |
| 21 | 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 |
| 22 | 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 | |||
| 23 | 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 |
| 24 | 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 |
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | |
| 30 | 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 |
| 31 | 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 | ||
| 32 | 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 |
| 33 | 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 |
| 34 | 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 | |||
| 35 | 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 | |||
| 36 | 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 | |||
| 37 | 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 |