UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032022 |
|---|---|
| Receipt number | 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 | 2023/04/03 10:48:33 |
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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 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)
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
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
hozumi@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
| 2028 | 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
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036488
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