UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014387 |
|---|---|
| Receipt number | R000016746 |
| Scientific Title | A prospective multicenter comparative clinical trial between corticosteroid pulse therapy vs. combination therapy of oral corticosteroid and cyclosporine on Vogt-Koyanagi-Harada disease |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2019/04/15 10:55:40 |
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Basic information
Public title
A prospective multicenter comparative clinical trial between corticosteroid pulse therapy vs. combination therapy of oral corticosteroid and cyclosporine on Vogt-Koyanagi-Harada disease
Acronym
A comparative study between steroid-pulse therapy vs. orla steroid+cyclosporine combination theray on VKH disease
Scientific Title
A prospective multicenter comparative clinical trial between corticosteroid pulse therapy vs. combination therapy of oral corticosteroid and cyclosporine on Vogt-Koyanagi-Harada disease
Scientific Title:Acronym
A comparative study between steroid-pulse therapy vs. orla steroid+cyclosporine combination theray on VKH disease
Region
| Japan |
Condition
Condition
Vogt-Koyanagi- Harada disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect to prevent recurrance of VKH disease between cortocosteroid pulse therapy and oral prednisolone + cyclosporine combination therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy to prevent recurrances of uveitis and systemic inflammation of VKH disease, safety at one year after the initiation of therapies
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1.Steroid monotherapy group
methyl predonisolone (mPSL) 1000mg per day, intravenous infusion for 3 days
The oral PSL (either a daily dose of 1mg/kg or 60mg for 2 weeks
PSL will be tapered with decreasing dosage 10mg every 1weeks until 40mg
PSL will be tapered with decreasing dosage 5mg every 2weeks until 20mg
PSL will be tapered with decreasing dosage 2.5mg every 2weeks until PSL 5mg
PSL 3mg/day for 2 weeks, and therapy is terminated
Interventions/Control_2
2.Oral prednisolone and cyclosporine combination therapy group
Oral predonisolone (1mg/Kg or 60mg per day) for 2 weeks
PSL will be tapered with decreasing dosage 10mg every 1weeks until 40mg
At the time when the dose of prednisolone decreases to 35 mg / day, start the combined use of cyclosporine 3 mg / kg.
Oral predonisolone is decreased and terminated as the same manner of storoid monotherapy group, but cyclosporine is maintained 3-2mg/Kg per day until the PSL is terminated.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with VKH disease with active uveitis within 2 months after disease onset. Patients should meet the International Revised Criteria for VKH disease. In addition, patients must have at least one systemic symptome tipically seen in VKH disease.
Key exclusion criteria
1. Systemic steroids within 90 days
2. Abnormal values of complete blood counts
3. Abnormal liver enzymes and renal function
4. Infectious diseases(ex.tuberculosis, hepatitis B, hepatitis C, syphilis etc.)
5. Those who have diseases in which corticosteroids and cyclosporine are contraindication.
6. Those who are being treated with immune suppression agents other than prednisolone
7. Investigators declare a subject ineligible for any sound reasons
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Mochizuki |
Organization
Miyata Eye Hospital
Division name
Medical office
Zip code
885-0051
Address
6-3, Kurahara, Miyakonojyo, Miyazaki, Japan
TEL
0986-22-1441
m.manabu.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Komizo |
Organization
Miyata Eye Hospital
Division name
Medical office
Zip code
885-0051
Address
6-3, Kurahara, Miyakonojyo, Miyazaki, Japan
TEL
0986-22-1441
Homepage URL
komizo@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyata Eye Hospital
Address
6-3, Kurahara, Miyakonojyo, Miyazaki, Japan
Tel
0986-22-1441
ushihama@miyata-med.ne.jp
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
| 2014 | Year | 06 | Month | 27 | 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 | 06 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 28 | 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 | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016746
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