UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054981 |
|---|---|
| Receipt number | R000062822 |
| Scientific Title | Study of pulmonary sequelae in patients with anti-MDA-5 antibody-positive dermatomyositis who were able to survive for a long period of time. |
| Date of disclosure of the study information | 2024/07/25 |
| Last modified on | 2024/07/16 19:01:09 |
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Basic information
Public title
Study of pulmonary sequelae in patients with anti-MDA-5 antibody-positive dermatomyositis who were able to survive for a long period of time.
Acronym
Study of pulmonary sequelae in patients with anti-MDA-5 antibody-positive dermatomyositis
Scientific Title
Study of pulmonary sequelae in patients with anti-MDA-5 antibody-positive dermatomyositis who were able to survive for a long period of time.
Scientific Title:Acronym
Study of pulmonary sequelae in patients with anti-MDA-5 antibody-positive dermatomyositis
Region
| Japan |
Condition
Condition
anti-MDA-5 antibody-positive dermatomyositis
Classification by specialty
| Pneumology | Clinical immunology | Not applicable |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dermatomyositis is known to be associated with a high rate of interstitial lung lesions, especially in patients positive for anti-MDA-5 antibodies, a group with a poor prognosis for rapid progression of interstitial lung lesions. Although aggressive treatment with steroids and immunosuppressive drugs immediately after diagnosis often saves lives, there is no set protocol and no clear criteria for how long treatment should be given. Even if a patient is saved after the acute phase, there are no reports examining the extent of residual lung dysfunction and imaging negativity. In this study, we will examine the temporal changes in a group of survivors during the first 2 years after onset of illness to determine how many cases of lung damage remain.
Basic objectives2
Others
Basic objectives -Others
Assess activity and consider whether there is a possibility of reducing the drug dose.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ow oxygenation, serological data, pulmonary function tests, and chest CT imaging findings improve in surviving patients with anti-MDA-5 antibody-positive dermatomyositis.
Key secondary outcomes
Can the treatment be terminated?
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical information on patients diagnosed with dermatomyositis between January 1, 2008 and December 31, 2022 in the Department of Respiratory, Neurological and Collagen Diseases, Kurume University Hospital will be used. Among them, the number of anti-MDA-5 antibody-positive cases that could be saved is 28. All patients will be enrolled in the study except those who refuse to participate, which will be made public on the website in an opt-out format.
Selection criteria: Persons who meet all of the following criteria will be selected
1. Aged 20 years or older
2. Those diagnosed with dermatomyositis who test positive for anti-MDA-5 antibodies
3. Those who have survived past the acute phase of the disease and have survived for 2 years after the onset of the disease
Key exclusion criteria
Patients who meet any of the following criteria shall be excluded from eligibility
Patients who meet any of the following criteria will not be selected even if they meet the selection criteria
1. Those who are deemed inappropriate as research subjects by the principal investigator and the research coordinator.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tominaga |
Organization
Kurume University Schho of Medicine
Division name
Department of Community Medicine
Zip code
8300011
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942317586
tominaga_masaki@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Tominaga |
Organization
Kurume University School of Medicine
Division name
Department of Community Medicine
Zip code
8400853
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
TEL
0942317586
Homepage URL
tominaga_masaki@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University School of Medicine
Address
67 Asahi-machi, Kurume, Fukuoka, Japan
Tel
0942317586
tominaga_masaki@med.kurume-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not particular
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062822
