50. 皮膚筋炎／多発性筋炎 Dermatomyositis Clinical trials / Disease details
臨床試験数 : 182 / 薬物数 : 229 - (DrugBank : 88) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 147
| 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-UMIN000018376 | 2015/07/22 | 22/07/2015 | Efficacy and safety of rituximab for patients with severe rheumatic disease | Efficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease | Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome) | 1) Induction Therapy rituximab 375mg/m2 (max500mg) 1-4 times/1-2 weeks 2) Maintenance Therapy rituximab 375mg/m2 (max500mg) 1 times/6-12 months | Yokohama City University Hospital Department of Pediatrics | NULL | Complete: follow-up complete | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 2 | 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 | ||||
| 3 | EUCTR2006-000078-65-GB (EUCTR) | 08/12/2008 | 07/12/2010 | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis | Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis | Trade Name: Mabthera Product Name: Mabthera | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 202 | Phase 2 | Czech Republic;United Kingdom;Sweden | ||
| 4 | EUCTR2006-000078-65-CZ (EUCTR) | 12/11/2007 | 18/10/2007 | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM) | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM)and Adult Polmyositis (PM) - Rituximab in myositis (RIM) | Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis. MedDRA version: 9.1;Level: LLT;Classification code 10036102;Term: Polymyositis | Trade Name: Mabthera Product Code: Mabthera | Karolinska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 202 | United Kingdom;Czech Republic;Sweden | |||
| 5 | EUCTR2006-000078-65-SE (EUCTR) | 17/01/2007 | 02/11/2006 | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis | Rituximab in the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) - Rituximab in myositis | Adult polymyositis or adult dermatomyositis or juvenile dermatomyositis MedDRA version: 8.1;Level: LLT;Classification code 10036102;Term: Polymyositis | Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: Rituximab | Karolinska University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 202 | United Kingdom;Czech Republic;Sweden | |||
| 6 | NCT00106184 (ClinicalTrials.gov) | March 2006 | 21/3/2005 | Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) | Rituximab Therapy in Refractory Adult and Juvenile Idiopathic Inflammatory Myopathy (IIM) | Myositis;Dermatomyositis;Polymyositis;Juvenile Dermatomyositis | Drug: Rituximab;Drug: Placebo | University of Pittsburgh | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Genentech, Inc.;Biogen | Completed | 5 Years | N/A | All | 200 | Phase 2 | United States;Canada;Czech Republic;Sweden;United Kingdom |