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 | ChiCTR1900028143 | 2020-01-01 | 2019-12-13 | Effect of Tacrolimus on dermatomyositis/polymyositis | A Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis | dermatomyositis/polymyositis | Control group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide; | Department of Rheumatology and Immunology, Tianjin Medical University General Hospital | NULL | Pending | 18 | 70 | Both | Control group:20;Treatment group:20;Control group:20; | Phase 4 | China |
| 2 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus - Effect of grapefruit juice with Tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan |
| 6 | NCT02159651 (ClinicalTrials.gov) | April 1, 2014 | 6/6/2014 | A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia | Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Drug: tacrolimus | Astellas Pharma Inc | NULL | Completed | N/A | N/A | All | 179 | Japan | |
| 7 | JPRN-JMA-IIA00012 | 20/07/2007 | 05/07/2007 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controls | Interstitial pneumonitis associated with polymyositis/dermatomyositis | Intervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.. | IMPPACT study central office | Hokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and Dentistry | Completed | >=16 YEARS | <75 YEARS | BOTH | 20 | Phase 2-3 | Japan |
| 8 | NCT00504348 (ClinicalTrials.gov) | July 2007 | 19/7/2007 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical Controls | Interstitial Pneumonitis;Polymyositis;Dermatomyositis | Drug: Tacrolimus | Tokyo Medical and Dental University | Japan Medical Association;Astellas Pharma Inc | Completed | 16 Years | 74 Years | All | 25 | Phase 2/Phase 3 | Japan |