UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012478 |
|---|---|
| Receipt number | R000014604 |
| Scientific Title | Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2019/06/11 21:15:18 |
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Basic information
Public title
Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus
Acronym
Hydroxychloroquine for systemic lupus erythematosus
Scientific Title
Open label trial for efficacy and safety of Hydroxychloroquine for systemic lupus erythematosus
Scientific Title:Acronym
Hydroxychloroquine for systemic lupus erythematosus
Region
| Japan |
Condition
Condition
systemic lupus erythematosus
cutaneous lupus erythematosus
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of hydroxychloroquine in Japanese patients with SLE or CLE
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
CLASI score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with Hydroxychloroquine
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
Patients diagnosed with SLE or CLE
Patients without retinopathy examined by ophthalmologist.
Key exclusion criteria
Patients with severe insufficiency in liver, kidney, heart, bone marrow function.
Patients with current or previous history of retinopathy.
Patients allergic to 4-aminoquinoline.
Other patients who were judged to be ineligible for the study by an attending physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Kono |
Organization
Department of Internal Medicine, Teikyo University School of Medicine
Division name
Rheumatology and Allergy
Zip code
173-8605
Address
Kaga 2-11-1, Itabashi-ku, Tyoko173-8605
TEL
03-3964-1211
kono@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Kono |
Organization
Department of Internal Medicine, Teikyo University School of Medicine
Division name
Rheumatology and Allergy
Zip code
173-8605
Address
Kaga 2-11-1, Itabashi-ku, Tyoko173-8605
TEL
03-3964-1211
Homepage URL
kono@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Teikyo University School of Medicine
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
Teikyo University Ethics Committee
Address
Kaga 2-11-1, Itabashi-ku, Tyoko173-8605
Tel
03-3964-1211
turb-office@teikyo-u.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
帝京大学医学部附属病院 (東京都)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | 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
Management information
Registered date
| 2013 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014604
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
