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

  
11 trials found
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1ChiCTR2000036709
2020-10-012020-08-24Study on early warning of rapid progressive interstitial lung disease in dermatomyositisStudy on early warning of rapid progressive interstitial lung disease in dermatomyositis DermatomyositisGroup 1:Glucocorticoid + cyclophosphamide + cyclosporin;Group 2:Glucocorticoid + cyclophosphamide + Tofacitinib;Zhongshan Hospital of Fudan UniversityNULLPending1860BothGroup 1:15;Group 2:15;N/AChina
2ChiCTR1900025087
2019-09-012019-08-10Cyclosporine A in the treatment of polymyositis /dermatomyositis associated interstitial pulmonary disease: a prospective, opened, multicenter, randomized, controlled clinical studyCyclosporine 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 Diseasetreatment group:CsA+glucocorticoid;control group:CTX+glucocorticoid;Guangdong Provincial People's HospitalNULLPendingBothtreatment group:75;control group:75;Phase 4China
3JPRN-UMIN000015469
2014/10/2018/10/2014Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung diseaseComparison 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 diseasearm1: 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 MedicineNULLComplete: follow-up complete18years-old75years-oldMale and Female50Not selectedJapan
4JPRN-UMIN000001866
2009/04/0110/04/2009Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositisContinuous 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 MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female10Not selectedJapan
5EUCTR2005-003956-37-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
6EUCTR2005-003956-37-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
7EUCTR2005-003956-37-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
8EUCTR2005-003956-37-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
9EUCTR2005-003956-37-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
10EUCTR2005-003956-37-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
11NCT00323960
(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