UMIN-CTR Clinical Trial

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
Email	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
Email	kono@med.teikyo-u.ac.jp

Sponsor
Institute	Department of Internal Medicine, Teikyo University School of Medicine
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	Teikyo University Ethics Committee
Address	Kaga 2-11-1, Itabashi-ku, Tyoko173-8605
Tel	03-3964-1211
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014604