UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033119 |
|---|---|
| Receipt number | R000037769 |
| Scientific Title | The optic side effects of hydroxychloroquine in Japanese CLE / SLE patients |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2023/06/28 18:07:19 |
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Basic information
Public title
The optic side effects of hydroxychloroquine in Japanese CLE / SLE patients
Acronym
The optic side effects of hydroxychloroquine
Scientific Title
The optic side effects of hydroxychloroquine in Japanese CLE / SLE patients
Scientific Title:Acronym
The optic side effects of hydroxychloroquine
Region
| Japan |
Condition
Condition
Cutaneous lupus erythematosus and systemic lupus erythematosus
Classification by specialty
| Clinical immunology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify the incidence and the form of hydroxychloroquine retinopathy in Japan.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence and the form of hydroxychloroquine retinopathy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.When consent acquisition is 20 years old and over 100 years old
2.One who was supposed to have plaquenil adaptation in collagen disease internal medicine or dermatology
Key exclusion criteria
1. One who was refused to obtain consent
2. Other who judged that the research director is inappropriate as the research subject
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University Hospital
Division name
Department of Ophthalmology
Zip code
1130033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
tinoma@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takenori |
| Middle name | |
| Last name | Inomata |
Organization
Juntendo University Hospital
Division name
Department of Ophthalmology
Zip code
1130033
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
tinoma@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospilal, Juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.ac.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
| 2018 | Year | 06 | Month | 30 | 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
500
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1. Basic information: age, gender, diagnosis name, hematological examination, blood biochemical examination
2. Ophthalmic examination: visual acuity, intraocular pressure, visual field, color vision, fundus examination, fundus photograph, autofluorescence of the fundus, retinal tomography examination
Management information
Registered date
| 2018 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037769
