44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000024574 | 2018/07/02 | 01/05/2017 | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ | Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA) | TCZ group Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. IVCY group Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. | Tokyo women's medical universityInstitute of rheumatology | Hokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University Hospital | Recruiting | 20years-old | 85years-old | Male and Female | 48 | Phase 2 | Japan |
| 2 | JPRN-JMA-IIA00325 | 01/07/2018 | 23/01/2018 | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis | Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA) | Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. . Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.. | Masayoshi Harigai | NULL | Pending | >=20 YEARS | <80 YEARS | BOTH | 48 | Phase 2 | Japan |
| 3 | 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 | Not Recruiting | 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 | Hungary;United States;United Kingdom;Switzerland;Spain;New Zealand;Canada;Austria;Czech Republic;Netherlands;Sweden;Belgium;Norway;Ireland;Denmark;Italy;Australia;France;Germany | ||
| 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 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 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 | NCT02807103 (ClinicalTrials.gov) | December 5, 2016 | 20/5/2016 | Rituximab in Eosinophilic Granulomatosis With Polyangiitis | Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, Randomized, Controlled, Double-blind Study | Eosinophilic Granulomatosis With Polyangiitis (EGPA) | Drug: Rituximab;Drug: Placebo-rituximab;Drug: Cyclophosphamide;Drug: Placebo-cyclophosphamide | Assistance Publique - Hôpitaux de Paris | French Vasculitis Study Group | Completed | 18 Years | N/A | All | 107 | Phase 3 | France |
| 15 | EUCTR2016-000275-25-FR (EUCTR) | 21/03/2016 | 13/04/2016 | Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS | Evaluation of Rituximab-based Regimen Compared to Conventional Therapeutic Strategy For Remission Induction In Patients With Newly-Diagnosed or Relapsing Eosinophilic Granulomatosis With Polyangiitis. Prospective, randomized, controlled, double-blind study. - REOVAS | Patients with a diagnosis of EGPA with newly-diagnosed disease or with a relapsing disease at the time of screening MedDRA version: 19.0;Level: PT;Classification code 10048594;Term: Allergic granulomatous angiitis;System Organ Class: 10021428 - Immune system disorders | Trade Name: RITUXIMAB Product Name: RITUXIMAB INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Trade Name: CYCLOPHOSPHAMIDE Product Name: CYCLOPHOSPHAMIDE INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: MESNA Product Name: MESNA INN or Proposed INN: mesna Other descriptive name: MESNA | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France | ||
| 16 | EUCTR2011-001219-30-DE (EUCTR) | 17/01/2012 | 20/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 17 | EUCTR2011-001219-30-GB (EUCTR) | 08/11/2011 | 12/07/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 18 | NCT01446211 (ClinicalTrials.gov) | November 2011 | 20/9/2011 | Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis) | Wegeners Granulomatosis | Drug: Gusperimus + glucocorticoids;Drug: cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids | Nordic Pharma SAS | NULL | Terminated | 18 Years | 75 Years | Both | 4 | Phase 3 | Czech Republic |
| 19 | EUCTR2011-001219-30-ES (EUCTR) | 14/10/2011 | 04/07/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener?s Granulomatosis) - SPARROW study ? SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener?s granulomatosis) | Relapse of Wegener?s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | United Kingdom;Slovakia;Russian Federation;Germany;Czech Republic;Netherlands;France;Spain;Italy;United States;Sweden | |||
| 20 | EUCTR2011-001219-30-SK (EUCTR) | 28/09/2011 | 05/10/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 14.0;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma SAS | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 21 | EUCTR2011-001219-30-SE (EUCTR) | 31/08/2011 | 21/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 22 | EUCTR2011-001219-30-CZ (EUCTR) | 18/08/2011 | 20/06/2011 | Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener’s Granulomatosis | Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus versus Conventional Therapy in Relapse of Granulomatosis with Polyangiitis (Wegener’s Granulomatosis) - SPARROW study – SPAnidin in Relapsing gRanulomatosis with pOlyangiitis (Wegener’s granulomatosis) | Relapse of Wegener’s Granulomatosis MedDRA version: 13.1;Level: PT;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 10047065 - Vascular disorders MedDRA version: 13.1;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Gusperimus INN or Proposed INN: gusperimus Trade Name: Endoxan® 500 mg Product Name: Cyclophosphamidum 500 mg INN or Proposed INN: cyclophosphamide Trade Name: Azathioprin-ratiopharm® 25 mg Filmtabletten Product Name: Azathioprine 25 mg INN or Proposed INN: azathioprine Trade Name: Metex 2,5 mg Tabletten Product Name: Methotrexate 2.5 mg INN or Proposed INN: methotrexate Trade Name: METOJECT 10 mg/ml, solution injectable en seringue pré-remplie Product Name: Methotrexate 25 mg INN or Proposed INN: methotrexate | Nordic Pharma France | NULL | Not Recruiting | Female: yes Male: yes | 216 | France;United States;Czech Republic;Slovakia;Spain;Russian Federation;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 |