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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:	17 October 2023
Main ID:	JPRN-UMIN000032022
Date of registration:	01/04/2018
Prospective Registration:	Yes
Primary sponsor:	Hamamatsu University School of Medicine
Public title:	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
Scientific title:	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
Date of first enrolment:	2018/04/01
Target sample size:	66
Recruitment status:	Recruiting
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036488
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Hironao Hozumi
Address:	1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan 4313192
Telephone:	+81-53-435-2263
Email:	hozumi@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
Telephone:	+81-53-435-2263
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 requires systemic high dose corticosteroid, immunosuppressants, intravenous immunoglobulin therapy, plasma exchange, or biologic agents for a disease other than PM/DM/CADM-ILD at the registration (2) Patients with severe respiratory failure (PaO2 < 50 Torr) (3) Patients with contraindication of prednisolone or tacrolimus (4) Patients with a serious comorbidity (e.g. advanced malignancy, imminent aortic aneurysm, and Liver cirrhosis) (5) Patients with anti-MDA5 antibody (6) 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-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease

Intervention(s)

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.

Primary Outcome(s)

Progression free survival and progression free survival rate at 12 and 24 month

Secondary Outcome(s)

Disease control rate at 1 month Recurrence free survival and recurrence free survival rate at 12 and 24 month Incidence of adverse events Overall survival and overall survival rate at 12 and 24 month Non-elective hospitalization rate (all-cause, PM/DM/CADM-ILD related, and non-PM/DM/CADM-ILD related) Change in PM/DM/CADM-ILD related symptom, FVC, FEV1, KL-6, SP-D, anti-aminoacyl-tRNA synthetase antibody titer, Chest HRCT findings)

Secondary ID(s)

Source(s) of Monetary Support

Hamamatsu University School of Medicine

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 19/03/2018
Contact:

rinri@hama-med.ac.jp

Hamamatsu University School of Medicine

+81-53-435-2680

rinri@hama-med.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2028
URL:

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