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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032022
Receipt No. R000036488
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
Date of disclosure of the study information 2018/04/01
Last modified on 2019/06/12

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Basic information
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
Acronym Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD
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
Scientific Title:Acronym Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD
Region
Japan

Condition
Condition anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety between corticosteroid monotherapy and combination therapy of corticosteroid and tacrolimus for anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival and progression free survival rate at 12 and 24 month
Key secondary outcomes Disease control rate at 1 and 3 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, DLCO, PaO2, SPO2, KL-6, SP-D, anti-aminoacyl-tRNA synthetase antibody titer, Chest HRCT findings)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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).
Interventions/Control_2 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.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria PM/DM/CADM-ILD patients who are positive for any of serum anti-aminoacyl tRNA-synthetase antibodies including anti-Jo-1 antibody and have not previously received treatment for PM/DM/CADM-ILD are included in this study.

Bohan and Peter criteria with slight modification:
1) systemic muscle weakness or myalgia, 2) increased serum muscle enzyme levels, 3) electromyographic (EMG) evidence of myopathic changes or muscular signal abnormalities on MRI, 4) typical histologic findings in muscle biopsies, and/or 5) characteristic dermatologic manifestations of DM.
The diagnosis is considered definite, probable, or possible according to the number of criteria fulfilled (at least 4, 3, or 2, respectively, including the dermatologic manifestations for diagnosis of DM), and patients with definite or probable PM/DM are included in the study.

Sontheimer criteria with slight modification:
CADM is diagnosed when a patient had 1) a skin rash characteristic of DM 2) without clinical evidence of muscle disease and 3) with little or no increase in the serum creatine kinase (CK) level during the observation period.

ILD:
ILD is diagnosed on the basis of the presence of high resolution computed tomography (HRCT) abnormalities in combination with one or more of the following; 1) progressive on HRCT, 2) dyspnea on exertion (modified MRC score 1 or more), 3) PaO2 < 80 Torr, 4) %FVC < 80% or %DLCO < 80%.
Key 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
Target sample size 66

Research contact person
Name of lead principal investigator
1st name Takafumi
Middle name
Last name Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code 4313192
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL +81-53-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name Hironao
Middle name
Last name Hozumi
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code 4313192
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL +81-53-435-2263
Homepage URL
Email hozumi@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
Tel +81-53-435-2680
Email rinri@hama-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 磐田市立総合病院 (静岡県)
国立病院機構天竜病院 (静岡県)
JA静岡厚生連 遠州病院 (静岡県)
静岡県立総合病院 (静岡県)
静岡済生会総合病院 (静岡県)
静岡市立静岡病院 (静岡県)
静岡市立清水病院 (静岡県)
静岡赤十字病院 (静岡県)
聖隷浜松病院 (静岡県)
聖隷三方原病院 (静岡県)
浜松労災病院 (静岡県)
浜松医療センター (静岡県)
藤枝市立総合病院 (静岡県)

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 19 Day
Date of IRB
2018 Year 03 Month 19 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 30 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036488

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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