UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014344 |
|---|---|
| Receipt number | R000016699 |
| Scientific Title | Efficacy and safety of concomitant use of three immunosuppressant therapy for anti-MDA5 antibody-positive dermatomyositis with interstitial pneumonia |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2019/04/29 22:10:43 |
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Basic information
Public title
Efficacy and safety of concomitant use of three immunosuppressant therapy for anti-MDA5 antibody-positive dermatomyositis with interstitial pneumonia
Acronym
Therapy for anti-MDA5 antibody positive interstitial pneumonia
Scientific Title
Efficacy and safety of concomitant use of three immunosuppressant therapy for anti-MDA5 antibody-positive dermatomyositis with interstitial pneumonia
Scientific Title:Acronym
Therapy for anti-MDA5 antibody positive interstitial pneumonia
Region
| Japan |
Condition
Condition
dermatomyositis with interstitial pneumonia
Classification by specialty
| Pneumology | Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of concomitant use of three immunosuppressant therapy for anti-MDA5 antibody-positive dermatomyositis with interstitial pneumonia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Probability of survival at 6 month and safety.
Key secondary outcomes
Change of symptom, biomarker (ferritin, IL-6, IL-18, M-CSF), titer of anti-MDA5 antibody, and chest CT.
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
Efficacy and safety of concomitant use of three immunosuppressant therapy for anti-MDA5 antibody-positive dermatomyositis with interstitial pneumonia
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dermatomyositis with anti-MDA5 antibody-positive interstitial pneumonia
Key exclusion criteria
Patients who have active tuberculosis or hepatitis B virus infection.
Patients who have malignancy when dermatomyositis is diagnosed.
Patients under 16 years old.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuneyo Mimori |
Organization
Kyoto University Graduate School of Medicine
Division name
Rheumatology and Clinical Immunology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3793
mimorit@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ran Sasai-Nakashima |
Organization
Kyoto University Graduate School of Medicine
Division name
Rheumatology and Clinical Immunology
Zip code
Address
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
075-751-3793
Homepage URL
ranran@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (No.25293222)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Red Cross Hospital
Kitano Hospital
Tenri Hospital
Hiroshima University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016699
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
