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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-jRCTs031180050 |
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Date of registration:
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07/12/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hydroxychloroquine for Japanese patients with rheumatoid arthritis
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Scientific title:
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Efficacy and safety of hydroxychloroquine for Japanese patients with rheumatoid arthritis |
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Date of first enrolment:
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26/12/2017 |
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Target sample size:
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120 |
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Recruitment status: |
Complete |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCTs031180050 |
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Study type:
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Interventional |
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Study design:
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non-randomized controlled trial, open(masking not used), historical control, single assignment, treatment purpose
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Phase:
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2-3
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Contacts
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Name:
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Yuko
Kaneko |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
160-8582
Tokyo
Japan |
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Telephone:
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+81-3-5363-3786 |
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Email:
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ykaneko.z6@keio.jp |
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Affiliation:
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Keio University Hospital |
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Name:
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Hiroshi
Takei |
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Address:
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35 Shinanomachi, Shinjuku-ku, Tokyo
160-8582
Tokyo
Japan |
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Telephone:
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+81-3-5363-3786 |
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Email:
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takei_hiroshi7@hotmail.com |
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Affiliation:
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Keio University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Rheumatoid arthritis patients with active disease (DAS28 greater than or equal to 2.6) over 18 years old
Exclusion criteria: Contraindication to HCQ, e.g. history of retinopathy and hypersensitivity to 4-aminoquinoline
Age minimum:
>= 18age old
Age maximum:
Not applicable
Gender:
Both
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Health Condition(s) or Problem(s) studied
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D001172
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Rheumatoid arthritis
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Intervention(s)
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Treatment with hydroxychloroquine for 24 weeks
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D006886
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Primary Outcome(s)
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Achievement rate of ACR20 at week 24
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Secondary Outcome(s)
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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
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Secondary ID(s)
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UMIN000023989
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Source(s) of Monetary Support
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Sanofi K.K.
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Ethics review
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Status: Approval
Approval date:
Contact:
med-rinri-jimu@adst.keio.ac.jp
Certified Review Board of Keio
+81-3-5363-3503
med-rinri-jimu@adst.keio.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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23/04/2023 |
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Date Completed:
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12/09/2020 |
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URL:
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