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

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 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

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

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
Registered date File name