UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007673 |
|---|---|
| Receipt number | 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 22:24:12 |
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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
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
horsedoctor@leaf.ocn.ne.jp
Sponsor or person
Institute
Graduate School of Medicine Kyoto University
Rheumatology and Clinical Immunology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009046
