UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023989
Receipt No. R000024831
Scientific Title Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis
Date of disclosure of the study information 2017/01/01
Last modified on 2018/03/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis
Acronym Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis
Scientific Title Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis
Scientific Title:Acronym Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety in Japanese patients with rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Achievement rate of ACR20 at week 24
Key secondary outcomes Achievement rate of improving DAS28 category at weeks 4, 8, 12 and 24
Achievement rate of low disease activity in DAS 28 at weeks 4, 8, 12 and 24
Achievement rate of clinical remission in DAS 28 at weeks 4, 8, 12 and 24
Achievement rate of functional remission in HAQ at weeks 4, 8, 12 and 24
Achievement rate of structural remission in modified total Sharp score at week 24
Achievement rate of ACR 20 at at weeks 4, 8, and 12
Achievement rate of ACR 50/70 at weeks 4, 8, 12 and 24
Adverse effects during whole study

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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 hydroxyxhloroquine for 24 weeks.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who fulfill the following four criteria in Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
1) Age 18- years
2) RA satisfying either the 1987 ACR criteria or 2010 ACR/ EULAR criteria
3) active disease (DAS28 2.6-) with poor prognostic factors with methotrexate treatment for over 3 months (stable dose for at least 4 weeks) or active disease with two or more oral conventional synthetic DMARDs for over 3 months (stable dose for at least 4 weeks)
4) One or more swollen joints and one or more tender joints
5) Written informed consent provided
6) Prior use of biological agent is permitted
Key exclusion criteria 1) Pregnancy or hope to bear a child
2) Contraindication to HCQ, e.g. history of retinopathy and hypersensitivity to 4-aminoquinoline
3) Uncontrollable diabetes mellitus
4) Porphyria
5) Psoriasis
6) G6PD deficiency
7) Ineligible for the study judged by physicians
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3786
Email tsutake@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kaneko
Organization Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-5363-3786
Homepage URL
Email ykaneko@z6.keio.jp

Sponsor
Institute Division of Rheumatology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Sanofi
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2017 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
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 10 Month 30 Day
Date analysis concluded
2020 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 09 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024831

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.