UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001866 |
|---|---|
| Receipt number | R000002247 |
| Scientific Title | Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2019/10/20 15:55:50 |
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Basic information
Public title
Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis
Acronym
Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis
Scientific Title
Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis
Scientific Title:Acronym
Continuous intravenous infusion therapy with cyclosporine A for rapidly progressive interstitial pneumonia associated with dermatomyositis and polymyositis
Region
| Japan |
Condition
Condition
Dermatomyositis or polymyositis with interstitial pneumonia
Classification by specialty
| Neurology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate therapeutic efficacy of continuous intravenous infusion of cyclosporine A (CyA) for rapidly progressive interstitial pneumonia (IP) associated with dermatomyositis (DM) and/or polymyositis (PM)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical symptoms, Respiratory functional evaluation, Chest CT and X-ray, Blood examinations
Key secondary outcomes
To evaluate long-term prognosis
To establish an effective therapeutic strategy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
(1)The patients are initially treated with methylprednisolone (m-PSL) pulse (1000 mg daily for three days) followed by oral prednisolone (1mg/kg daily).
(2)Continuous intravenous CyA (2 mg/kg daily for initial dose) is started following m-PSL pulse therapy, and the dosage will be adjusted to a level of 200-300ng/ml.
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
In addition of fulfilling diagnostic criteria for DM/PM or clinically amyopathic DM and the presence of IP on chest X-ray and/or CT, one or more of the following clinical findings are necessary ; (1) %VC is lower than 80%, (2) % DLCO is lower than 70%, (3) acute respiratory symptoms (dyspnea, dry cough), (4) PaO2 is lower than 70mmHg.
Key exclusion criteria
We exclude patients with active infectious disease, severe renal dysfunction and malignancy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shimojima |
Organization
Shinshu University School of Medicine
Division name
Department of Neurology and Rheumatology
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2673
yshimoji@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shimojima |
Organization
Shinshu University School of Medicine
Division name
Department of Neurology and Rheumatology
Zip code
Address
3-1-1 Asahi, Matsumoto, Japan
TEL
0263-37-2673
Homepage URL
yshimoji@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Neurology and Rheumatology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 10 | 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
| 2009 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2019 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002247
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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