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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001866
Receipt No. 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

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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
Email 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
Email yshimoji@shinshu-u.ac.jp

Sponsor
Institute Department of Neurology and Rheumatology, Shinshu University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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