UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022605 |
|---|---|
| Receipt number | R000026055 |
| Scientific Title | Significance of myositis-specific autoantibodies (MSA) for clinical features in polymyositis/dermatomyositis-associated interstitial lung disease |
| Date of disclosure of the study information | 2016/06/04 |
| Last modified on | 2024/09/17 19:48:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Significance of myositis-specific autoantibodies (MSA) for clinical features in polymyositis/dermatomyositis-associated interstitial lung disease
Acronym
MSA in PM/DM-ILD
Scientific Title
Significance of myositis-specific autoantibodies (MSA) for clinical features in polymyositis/dermatomyositis-associated interstitial lung disease
Scientific Title:Acronym
MSA in PM/DM-ILD
Region
| Japan |
Condition
Condition
Polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze prevalence of myositis-specific autoantibodies (MSA) prospectively and clarify the difference of clinical features and prognosis according to MSA status in the patients with PM/DM-ILD
Basic objectives2
Others
Basic objectives -Others
Development of prospective observational cohort of patients with PM/DM-ILD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical feature and overall survival according to MSA status
Key secondary outcomes
Prevalence of each myositis-specific autoantibodies
Change of clinical symptoms, pulmonary function tests, chest HRCT findings, and laboratory findings during follow up period (3 years)
Comparison of therapeutic regimen
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The diagnosis of PM or DM was based on the criteria of Bohan and Peter criteria: 1) systemic muscle weakness, 2) increased serum muscle enzyme levels, 3) electromyographic (EMG) evidence of myopathic changes, 4) typical histologic findings in muscle biopsies, and/or 5) characteristic dermatologic manifestations of DM. The diagnosis was 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 were included in the study. CADM was diagnosed when a patient had a skin rash characteristic of DM without clinical evidence of muscle disease and with little or no increase in the serum creatine kinase (CK) level.
Interstitial lung disease was diagnosed on the basis of the presence of high resolution computed tomography abnormalities in combination with one or more of the following; dyspnea on exertion, serum KL-6 level > 500 U/ml, arterial oxygen tension (PaO2) < 80mmHg, %FVC < 80%, %DLCO < 65%.
Key exclusion criteria
Patients who are unable to get informed consent
Target sample size
100
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 Chuo-ku, Hamamatsu, 431-3192 Japan
TEL
053-435-2263
suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Fujisawa |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
4313192
Address
1-20-1 Handayama Chuo-ku, Hamamatsu, 431-3192 Japan
TEL
053-435-2263
Homepage URL
fujisawa@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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1 Handayama CHuo-ku, Hamamatsu, 431-3192 Japan
Tel
053-435-2263
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 04 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Comparison of clinical feature and overall survival according to MSA status
Prevalence of each myositis-specific autoantibodies
Change of pulmonary function tests, chest HRCT findings and laboratory findings during follow up period (3 years)
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026055
