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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 16 July 2019
Main ID:  JPRN-UMIN000032193
Date of registration: 13/04/2018
Prospective Registration: No
Primary sponsor: Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine
Public title: 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
Scientific title: 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
Date of first enrolment: 2018/04/11
Target sample size: 40
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036705
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name:     Tomoyuki Fujisawa
Address:  1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan Japan
Telephone: 053-435-2263
Email: fujisawa@hama-med.ac.jp
Affiliation:  Hamamatsu University School of Medicine Second Division, Department of Internal Medicine
Name:     Takafumi Suda
Address:  1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan Japan
Telephone: 053-435-2263
Email: suda@hama-med.ac.jp
Affiliation:  Hamamatsu University School of Medicine Second Division, Department of Internal Medicine
Key inclusion & exclusion criteria
Inclusion criteria:
Exclusion criteria: Patients who meet the following criteria are excluded from this study:
(1) Patients who require systemic high dose corticosteroid, immunosuppressants, intravenous immunoglobulin therapy, plasma exchange, or biologic agents for a disease other than DM/CADM-ILD at the registration
(2) Patients with contraindication of prednisolone or tacrolimus
(3) Patients with a serious comorbidity (e.g. advanced malignancy, imminent aortic aneurysm, and Liver cirrhosis)
(4) Patients who are judged unqualified for this study by attending physician


Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease
Intervention(s)
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.
Primary Outcome(s)
Progression free survival and progression free survival rate at 12 month in patients with anti-MDA5 antibody-positive DM/CADM-ILD without poor prognostic factors
Secondary Outcome(s)
"The patients without poor prognostic factor"
Overall survival and overall survival rate at 12 month
Change in FVC, FEV1, DLCO, PaO2, SPO2, KL-6, SP-D, anti-MDA5 antibody titer, Chest HRCT findings
Incidence of adverse events

"The patients with poor prognostic factor"
Overall survival and overall survival rate at 12 month.
Secondary ID(s)
Source(s) of Monetary Support
Hamamatsu University School of Medicine
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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