50. 皮膚筋炎/多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151
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 |
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1 | ChiCTR2200059159 | 2022-04-26 | 2022-04-26 | Efficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled study | Efficacy and safety of triple therapy based on prognostic risk stratification in patients with anti-MDA5 antibody-positive dermatomyositis: a multicenter, prospective, randomized controlled study | anti-MDA5 antibody-positive dermatomyositis | experimental group:High-dose glucocorticoid + cyclophosphamide + calcineurin inhibitor;control group:High-dose glucocorticoid + cyclophosphamide or calcineurin inhibitor; | First Affiliated Hospital of Nanjing Medical University | NULL | Pending | 18 | 100 | Both | experimental group:60;control group:60; | Phase 4 | China |
2 | ChiCTR2000036709 | 2020-10-01 | 2020-08-24 | Study on early warning of rapid progressive interstitial lung disease in dermatomyositis | Study on early warning of rapid progressive interstitial lung disease in dermatomyositis | Dermatomyositis | Group 1:Glucocorticoid + cyclophosphamide + cyclosporin;Group 2:Glucocorticoid + cyclophosphamide + Tofacitinib; | Zhongshan Hospital of Fudan University | NULL | Pending | 18 | 60 | Both | Group 1:15;Group 2:15; | N/A | China |
3 | EUCTR2012-003633-42-GB (EUCTR) | 18/10/2013 | 22/08/2013 | A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases | A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD | A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
4 | JPRN-UMIN000031931 | 2010/12/01 | 27/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe dermatomyositis - Autologous hematopoietic stem cell transplantation for severe dermatomyositis | Dermatomyositis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 10 | Phase 2 | Japan |