UMIN-CTR Clinical Trial

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
Last 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
Email	m.manabu.oph@tmd.ac.jp

Public contact
1st 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
Email	komizo@miyata-med.ne.jp

Sponsor
Institute	Miyata Eye Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016746