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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032193
Receipt No. R000036705
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
Date of disclosure of the study information 2018/04/13
Last modified on 2019/06/12

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Basic information
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
Acronym Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD
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
Scientific Title:Acronym Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD
Region
Japan

Condition
Condition anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-MDA5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease (ILD) without poor prognostic factors.

To investigate the clinical course and prognosis for patients with anti-MDA5 antibody-positive DM/CADM-ILD with poor prognostic factors.

When patients have any or some of the following factors, they were defined as "with poor prognostic factor". When patients have none of the following factors, they were defined as "without poor prognostic factor".
1, Rapidly progressive interstitial lung disease
2, Serum ferritin level is more than 800 ng/ml
3, PaO2 < 65 Torr at room air
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 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
Key secondary outcomes "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.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
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 Patients with DM/CADM-ILD who are positive for serum anti-MDA5 antibodies and have not previously received treatment for DM/CADM-ILD.
Key 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
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL 053-435-2263
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Fujisawa
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1 Handayama Higashi-ku, Hamamatsu, 431-3192 Japan
TEL 053-435-2263
Homepage URL
Email fujisawa@hama-med.ac.jp

Sponsor
Institute Second Division, Department of Internal Medicine, 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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 13 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 16 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 11 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=R000036705

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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