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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900025087 | 2019-09-01 | 2019-08-10 | Cyclosporine A in the treatment of polymyositis /dermatomyositis associated interstitial pulmonary disease: a prospective, opened, multicenter, randomized, controlled clinical study | Cyclosporine A in the Treatment of Polymyositis /Dermatomyositis With Interstitial Lung Disease (CTP /DMILD): a Prospective, Opened, Randomized, Multicenter, Controlled Trial | Polymyositis/Dermatomyositis associated Interstitial Lung Disease | treatment group:CsA+glucocorticoid;control group:CTX+glucocorticoid; | Guangdong Provincial People's Hospital | NULL | Pending | Both | treatment group:75;control group:75; | Phase 4 | China | ||
| 2 | JPRN-UMIN000015469 | 2014/10/20 | 18/10/2014 | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD | polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease | arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml. | Second Division, Department of Internal medicine, Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 3 | JPRN-UMIN000001866 | 2009/04/01 | 10/04/2009 | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis - Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis | Dermatomyositis or polymyositis with interstitial pneumonia | (1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily). (2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml. | Department of Neurology and Rheumatology, Shinshu University School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 10 | Not selected | Japan |
| 4 | EUCTR2005-003956-37-GB (EUCTR) | 18/06/2008 | 20/03/2008 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisolone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: prednisone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methotrexate Product Code: not available INN or Proposed INN: not availa | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 5 | EUCTR2005-003956-37-SE (EUCTR) | 23/02/2007 | 11/12/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Trade Name: treatment defined only by active substance Product Name: Prednisone Product Code: Not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: methylprednisolone Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: not available Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Cyclosporine A Product Code: not available INN or Proposed INN: not available Other descriptive name: not available Trade Name: treatment defined only by active substance Product Name: Methotrexate Product Code: not available | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 6 | EUCTR2005-003956-37-BE (EUCTR) | 13/11/2006 | 25/10/2006 | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Five year single blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate - PRINTO JDM Trial | Juvenile Dermatomyositis at onset | Product Name: Prednisolone INN or Proposed INN: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: Methylprednisolone sodium succinate Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Cyclosporine INN or Proposed INN: Cyclosporine A Product Name: Methotrexate INN or Proposed INN: Methotrexate Product Name: Methotrexate INN or Proposed INN: Methotrexate | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 7 | EUCTR2005-003956-37-DK (EUCTR) | 03/11/2006 | 15/09/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis: prednisone versus prednisone plus cyclosporine A versus prednisone plus methotrexate | Juvenile Dermatomyositis at onset | Product Name: Prednisone Product Name: methylprednisolone Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Cyclosporine Product Name: Metotrexate Product Name: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden | ||
| 8 | EUCTR2005-003956-37-NL (EUCTR) | 26/09/2006 | 01/06/2006 | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Five year single-blind, phase III effectiveness randomised actively controlled clinical trial in new onset juvenile dermatomyositis:prednisone versus prednisone plus cyclosporine A versus prednisone plus mehotrexate | Juvenile Dermatomyositis at onset | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | Istituto Giannina Gaslini | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 9 | EUCTR2005-003956-37-IT (EUCTR) | 02/05/2006 | 12/09/2006 | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMIZED ACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILE DERMATOMYOSITIS PREDNISONE VERSUS PREDNISONE PLUS CYCLOSPORINE A VERSUS PREDNISONE PLUS METHOTREXATE - ND | New Onset juvenile dermatomyositis MedDRA version: 6.1;Level: PT;Classification code 10012503 | INN or Proposed INN: Prednisone INN or Proposed INN: Methylprednisolone INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Ciclosporin INN or Proposed INN: Methotrexate INN or Proposed INN: Methotrexate | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 132 | Phase 3 | United Kingdom;Netherlands;Belgium;Italy;Sweden | ||
| 10 | NCT00323960 (ClinicalTrials.gov) | May 2006 | 9/5/2006 | Five-year Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis | Five-year Single-blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Dermatomyositis: Prednisone Versus Prednisone Plus Cyclosporine a Versus Prednisone Plus Methotrexate | Juvenile Dermatomyositis | Drug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTX | Istituto Giannina Gaslini | Pediatric Rheumatology International Trials Organization | Recruiting | 1 Year | 18 Years | Both | 120 | Phase 3 | Italy |