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 | JPRN-UMIN000032193 | 2018/04/11 | 13/04/2018 | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD | anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease | Patients without poor prognostic factors: combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months). Tacrolimus 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. For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months. | Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 2 | JPRN-UMIN000032022 | 2018/04/01 | 01/04/2018 | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD | anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease | Arm 1: corticosteroid (prednisolone) monotherapy for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Tacrolimus 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. | Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 66 | Not selected | Japan |
| 3 | 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 |
| 4 | ChiCTR-TRC-13003178 | 2013-05-01 | 2013-01-03 | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study | Polymyositis/Dermatomyositis | group1-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg / d, then reduce 2.5mg every two weeks to 5mg/d, maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group1-predinsone+MTX group:MTX 10-20mgQw×24w; MTX 7.5-10mgQw×48w, the usage of prednisone is the same as in the control group.;group1-predinsone+LEF group:LEF 20mg/d×24w; LEF 10mg/d×48w, the usage of prednisone is the same as in the control group.;group2-predinsone group(control group):Prednisone 1mg/kg/d (or eaqual dose prednisolone/ methylprednisolone)×6-8 weeks, biweekly reduction 5 mg to 30mg/d, then reduce 2.5mg every two weeks to 5mg/d,maintenance therapy to 72 weeks; seriously ill patient can consider the impact of initial methyl prednisolone 0.5-1.0g/d treatment×3days.;group2-predinsone+CTX group:CTX iv 0.8-1.0g/4w×24w; CTX iv 0.8-1.0g/12w×48w, the usage of prednisone is the same as in the control group.;group2-predinsone+MTX group:MMF 1.5-2.0g /d×24w; MMF 0.75-1g/d×48w, the usage of prednisone is the same as in the control group.; | Department of rheumatology, China-Japan Friendship hospital | NULL | Recruiting | 18 | 70 | Both | group1-predinsone group(control group):94;group1-predinsone+MTX group:94;group1-predinsone+LEF group:94;group2-predinsone group(control group):94;group2-predinsone+CTX group:94;group2-predinsone+MTX group:94; | China | |
| 5 | 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 |
| 6 | 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 | ||
| 7 | EUCTR2007-004410-13-CZ (EUCTR) | 12/03/2008 | 25/10/2007 | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | A PROSPECTIVE, RANDOMISED, ASSESSOR-BLIND, MULTICENTER STUDY OF EFFICACY AND SAFETY OF COMBINED TREATMENT OF METHOTREXATE + GLUCOCORTICOIDS VERSUS GLUCOCORTICOIDS ALONE IN PATIENTS WITH POLYMYOSITIS AND DERMATOMYOSITIS. - PROMETHEUS | active polymyositis, dermatomyositis MedDRA version: 9.1;Level: LLT;Classification code 10012503;Term: Dermatomyositis MedDRA version: 9.1;Classification code 10036102;Term: Polymyositis | Trade Name: Methotrexat Lachema 2,5mg Product Name: Methotrexat Lachema 2,5mg tbl. Product Code: 44/154/85-C INN or Proposed INN: METHOTREXATE Other descriptive name: methotrexate Trade Name: Prednison 5, 20 Léciva por. tablet nob. Product Name: Prednison 5, 20 Léciva por. tablet nob. Product Code: 56/104/75-C INN or Proposed INN: PREDNISON 5, 20 Léciva por. tablet nob Trade Name: Methotrexat Lachema 5 inj. sol Product Name: Methotrexate Lachema 5inj. sol Product Code: 44/196/81-C INN or Proposed INN: methotrexate Trade Name: Solu-medrol inj. PSO LQF 40mg Product Name: Solu-medrol inj. PSO lqf 40mg INN or Proposed INN: methylprednisoloni natrii succinas | Institute od Rheumatology Prague | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Czech Republic;Sweden | |||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | NCT00004357 (ClinicalTrials.gov) | September 1997 | 18/10/1999 | Absorption of Corticosteroids in Children With Juvenile Dermatomyositis | Phase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile Dermatomyositis | Vasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;Vasculitis | Drug: Methylprednisolone;Drug: Prednisolone | Northwestern University | Ann & Robert H Lurie Children's Hospital of Chicago | Completed | 4 Years | 21 Years | Both | 6 | Phase 2 | United States |