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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007673
Receipt No. R000009046
Scientific Title A study for the difference in effects of high-dose prednisolone therapy for autoimmune disease patients
Date of disclosure of the study information 2012/04/05
Last modified on 2012/04/05

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Basic information
Public title A study for the difference in effects of high-dose prednisolone therapy for autoimmune disease patients
Acronym A study for the difference in effects of high-dose prednisolone therapy for autoimmune disease patients
Scientific Title A study for the difference in effects of high-dose prednisolone therapy for autoimmune disease patients
Scientific Title:Acronym A study for the difference in effects of high-dose prednisolone therapy for autoimmune disease patients
Region
Japan

Condition
Condition rheumatic disease like dermatomyositis, polymyositis, systemic lupus erythematosus, vasculitides, adult Still's disease and so on.
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The effects of prednisolone are different between patients even when they suffer from the same disease. I believe that this difference comes from the differences in absorption and metabolism of prednisolone.
By measuring the blood concentration of prednisolone and investigating the single-nucleotide polymorphisms which correlate with the effects of prednisolone, I want to find the way to prospect the effects of prednisolone in individual patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of the Disease activity of rheumatic diseases 2 weeks after the induction of oral prednisolone therapy
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Rheumatic disease patients who receive oral high-dose (more than 0.8mg/kg/day) prednisolone monotherapy
Key exclusion criteria Patients who have taken oral prednisolone for long time
Patients who have allergy to prednisolone
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichiro Ohmura
Organization Graduate School of Medicine Kyoto University
Division name Rheumatology and Clinical Immunology
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine Kyoto University
Division name Rheumatology and Clinical Immunology
Zip code
Address
TEL
Homepage URL
Email horsedoctor@leaf.ocn.ne.jp

Sponsor
Institute Graduate School of Medicine Kyoto University
Rheumatology and Clinical Immunology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science & Technology
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
2012 Year 04 Month 05 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 Enrolling by invitation
Date of protocol fixation
2012 Year 02 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study
We observe the relationship between blood concentration of prednisolone and clinical findings like disease activity, severity of moon face, and avascular necrosis of the femoral head.

Management information
Registered date
2012 Year 04 Month 05 Day
Last modified on
2012 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009046

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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