Effect of MTX Discontinuation on Shingrix Response in RA
NCT ID: NCT06574594
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2024-08-22
2025-12-31
Brief Summary
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Discontinuation of methotrexate after shingrix immunization increase efficacy of the vaccine in patients with RA ?
Researchers will compare humoral and cell-mediated immunity against herpes zoster in RA patients who are vaccinated by shingrix, and compare these immunity between RA patients with MTX discontinuation and MTX continuation groups.
Participants will:
Vaccinated with shingrix twice. MTX continuation group will keep taking MTX after shingrix vaccination, whereas MTX discontinuation group will stop MTX for 2 weeks after shingrix vaccination.
Visit the clinic at baseline (first shingrix vaccination), 2 months later for 2nd shingrix vaccination, then 3 \& 6 months later from baseline to achieve blood sample.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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MTX discontinuation
methotrexate stop for 2 weeks after each shingrix vaccination
Methotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
MTX continuation
Methotrexate
methotrexate continuation group : keep methotrexate
Interventions
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Methotrexate
methotrexate discontinuation group : stop MTX for 2 weeks after each shingrix vaccination
Methotrexate
methotrexate continuation group : keep methotrexate
Eligibility Criteria
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Inclusion Criteria
* age over 19 years
* methotrexate user
* agree for vaccination with shingrix
Exclusion Criteria
* malignancy, current infection, pregnancy
19 Years
ALL
No
Sponsors
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Konkuk University Medical Center
OTHER
Responsible Party
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Hong Ki Min
Assistant Professor
Principal Investigators
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Hong Ki Min, MD, PhD
Role: STUDY_CHAIR
Konkuk University Medical Center
Locations
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Konkuk University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-02-038
Identifier Type: -
Identifier Source: org_study_id
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