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

  
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR-TRC-13003178
2013-05-012013-01-03Study of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical studyStudy of Treatment Approaches in Myositis (STRAIM): a prospective, multicenter, randomized and open label clinical study Polymyositis/Dermatomyositisgroup1-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 hospitalNULLRecruiting1870Bothgroup1-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
2EUCTR2005-003956-37-GB
(EUCTR)
18/06/200820/03/2008Five 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 methotrexateFive 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 onsetTrade 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 GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
3NCT00651040
(ClinicalTrials.gov)
May 200831/3/2008Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With PM and DMA 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.Polymyositis;DermatomyositisDrug: Prednisone;Drug: MethotrexateInstitute of Rheumatology, PragueKarolinska InstitutetCompleted18 Years80 YearsAll31Phase 3Czech Republic
4EUCTR2005-003956-37-SE
(EUCTR)
23/02/200711/12/2006Five 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 methotrexateFive 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 onsetTrade 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 GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
5EUCTR2005-003956-37-BE
(EUCTR)
13/11/200625/10/2006Five 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 TrialFive 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 onsetProduct 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 GentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
6EUCTR2005-003956-37-DK
(EUCTR)
03/11/200615/09/2006Five 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 methotrexateFive 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 onsetProduct Name: Prednisone
Product Name: methylprednisolone
Product Name: Cyclosporine
Product Name: Cyclosporine
Product Name: Cyclosporine
Product Name: Metotrexate
Product Name: Methotrexate
Istituto Giannina GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3Belgium;Denmark;Netherlands;United Kingdom;Italy;Sweden
7EUCTR2005-003956-37-NL
(EUCTR)
26/09/200601/06/2006Five 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 mehotrexateFive 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 onsetINN 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 GasliniNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
8EUCTR2005-003956-37-IT
(EUCTR)
02/05/200612/09/2006FIVE-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 - NDFIVE-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 GASLININULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United Kingdom;Netherlands;Belgium;Italy;Sweden
9NCT00323960
(ClinicalTrials.gov)
May 20069/5/2006Five-year Actively Controlled Clinical Trial in New Onset Juvenile DermatomyositisFive-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 MethotrexateJuvenile DermatomyositisDrug: 3 MPDN pulse + PDN;Drug: 3 MPDN pulse + PDN + CSA;Drug: 3 MPDN pulse + PDN + MTXIstituto Giannina GasliniPediatric Rheumatology International Trials OrganizationRecruiting1 Year18 YearsBoth120Phase 3Italy
10NCT00035958
(ClinicalTrials.gov)
August 20027/5/2002Understanding the Pathogenesis and Treatment of Childhood Onset DermatomyositisToward Improved Understanding of Pathogenesis and Treatment of Childhood Onset DermatomyositisDermatomyositisDrug: Prednisone;Drug: Methotrexate;Drug: EtanerceptChildren's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS);Immunex CorporationTerminated4 Years16 YearsBoth75Phase 2/Phase 3United States