44. 多発血管炎性肉芽腫症 Wegener granulomatosis Clinical trials / Disease details
臨床試験数 : 92 / 薬物数 : 106 - (DrugBank : 27) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 78
| 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 | EUCTR2021-000679-35-FR (EUCTR) | 07/09/2021 | 25/06/2021 | SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” | SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” - SATELITE | Granulomatosis with Polyangiitis;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Trade Name: ORENCIA INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Mycophénolate mofétil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Azathioprine Other descriptive name: AZATHIOPRINE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | France | ||
| 2 | NCT04871191 (ClinicalTrials.gov) | September 2021 | 26/2/2021 | Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis | Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis | Granulomatosis With Polyangiitis;Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis | Drug: Rituximab;Drug: Tocilizumab;Drug: Abatacept | Assistance Publique - Hôpitaux de Paris | URC-CIC Paris Descartes Necker Cochin | Not yet recruiting | 18 Years | N/A | All | 42 | Phase 2 | France |
| 3 | EUCTR2013-005535-24-GB (EUCTR) | 07/06/2016 | 03/12/2015 | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) | Abatacept (CTLA4-Ig) for the treatment of relapsing, non-severe, granulomatosis with polyangiitis (Wegener's) - ABROGATE | Granulomatosis with polyangiitis (GPA; Wegener's granulomatosis) MedDRA version: 19.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866 MedDRA version: 19.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;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: Orencia Product Name: Abatacept INN or Proposed INN: Abatacept | Univeristy of South Florida | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;France;Mexico;Canada;Spain;Ireland;Australia;Germany;Switzerland;Italy;United Kingdom;Sweden | ||
| 4 | EUCTR2013-005535-24-IE (EUCTR) | 04/05/2016 | 11/02/2016 | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE | Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000004866 MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;System Organ Class: 100000004866 MedDRA version: 20.1;Level: PT;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: Orencia Product Name: Abatacept (CTLA4-Ig) INN or Proposed INN: ABATACEPT | University of South Florida | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Phase 3 | United States;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Mexico;Canada;Belgium;Australia;Germany;Sweden | ||
| 5 | NCT02108860 (ClinicalTrials.gov) | April 2015 | 27/3/2014 | Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) (ABROGATE) | Granulomatosis With Polyangiitis (Wegener's);Granulomatosis With Polyangiitis;Wegener's Granulomatosis;ANCA-Associated Vasculitis | Drug: Abatacept;Drug: placebo | University of South Florida | The Cleveland Clinic;Bristol-Myers Squibb;University of Pennsylvania;National Institutes of Health (NIH);National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Recruiting | 15 Years | N/A | All | 66 | Phase 3 | United States;Canada;Germany;Ireland;United Kingdom |
| 6 | EUCTR2013-005535-24-DE (EUCTR) | 18/08/2017 | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) | Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) (ABROGATE) - ABROGATE | Relapsing, Non Severe, Granulomatosis with Polyangiitis (Wegener’s) MedDRA version: 20.0;Level: LLT;Classification code 10047889;Term: Wegeners granulomatosis;System Organ Class: 100000140455 MedDRA version: 20.0;Classification code 10047888;Term: Wegener's granulomatosis;Level: PT;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: Orencia Product Name: Abatacept (CTLA4-Ig) | University of South Florida | NULL | NA | Female: yes Male: yes | 150 | Phase 3 | United States;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Australia;Germany;Sweden |