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

  
13 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000032193
2018/04/1113/04/2018Efficacy 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 trialEfficacy 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 diseasePatients 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 MedicineNULLRecruiting20years-old80years-oldMale and Female40Not selectedJapan
2JPRN-UMIN000032022
2018/04/0101/04/2018Efficacy 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 trialEfficacy 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 diseaseArm 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 MedicineNULLRecruiting20years-old80years-oldMale and Female66Not selectedJapan
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
4ChiCTR-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
5JPRN-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
6EUCTR2005-003956-37-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
7EUCTR2007-004410-13-CZ
(EUCTR)
12/03/200825/10/2007A 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. - PROMETHEUSA 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 PragueNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Czech Republic;Sweden
8EUCTR2005-003956-37-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
9EUCTR2005-003956-37-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
10EUCTR2005-003956-37-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
11EUCTR2005-003956-37-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
12EUCTR2005-003956-37-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
13NCT00004357
(ClinicalTrials.gov)
September 199718/10/1999Absorption of Corticosteroids in Children With Juvenile DermatomyositisPhase II Study of Prednisolone/Methylprednisolone Absorption in Children With Juvenile DermatomyositisVasculitis, Hypersensitivity;Connective Tissue Diseases;Dermatomyositis;VasculitisDrug: Methylprednisolone;Drug: PrednisoloneNorthwestern UniversityAnn & Robert H Lurie Children's Hospital of ChicagoCompleted4 Years21 YearsBoth6Phase 2United States