One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.
NCT ID: NCT05069714
Last Updated: 2022-12-16
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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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2021-10-01
2022-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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MTX 1 week hold
Patients who will hold MTX for 1 week after an influenza vaccine.
MTX-hold
Temporary discontinuation of methotrexate for 1 or 2 weeks
MTX 2 week hold
Patients who will hold MTX for 2 weeks after an influenza vaccine.
MTX-hold
Temporary discontinuation of methotrexate for 1 or 2 weeks
Interventions
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MTX-hold
Temporary discontinuation of methotrexate for 1 or 2 weeks
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of RA per ACR criteria
* Must understand and voluntarily sign an informed consent form including writing consent for data protection
* Stable doses of methotrexate over the preceding 6 weeks
Exclusion Criteria
* Previous anaphylactic response to vaccine components or to egg.
* Acute infection with T \>38°C at the time of vaccination
* History of Guillain-Barre syndrome or demyelinating syndromes
* Blood transfusion within 6 months
* Any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary Sjogren's disease
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate
19 Years
ALL
Yes
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Seoul National Univ. Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Countries
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References
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Park JK, Kim MJ, Choi Y, Winthrop K, Song YW, Lee EB. Effect of short-term methotrexate discontinuation on rheumatoid arthritis disease activity: post-hoc analysis of two randomized trials. Clin Rheumatol. 2020 Feb;39(2):375-379. doi: 10.1007/s10067-019-04857-y. Epub 2019 Dec 10.
Park JK, Lee YJ, Shin K, Ha YJ, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Impact of temporary methotrexate discontinuation for 2 weeks on immunogenicity of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2018 Jun;77(6):898-904. doi: 10.1136/annrheumdis-2018-213222. Epub 2018 Mar 23.
Park JK, Lee MA, Lee EY, Song YW, Choi Y, Winthrop KL, Lee EB. Effect of methotrexate discontinuation on efficacy of seasonal influenza vaccination in patients with rheumatoid arthritis: a randomised clinical trial. Ann Rheum Dis. 2017 Sep;76(9):1559-1565. doi: 10.1136/annrheumdis-2017-211128. Epub 2017 May 3.
Park JK, Lee YJ, Shin K, Kang EH, Ha YJ, Park JW, Kim MJ, Kim MH, Choi SR, Jung Y, Lee JH, In Jung J, Kim JY, Winthrop KL, Lee EB. A Multicenter, Prospective, Randomized, Parallel-Group Trial on the Effects of Temporary Methotrexate Discontinuation for One Week Versus Two Weeks on Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2023 Feb;75(2):171-177. doi: 10.1002/art.42318. Epub 2022 Dec 7.
Other Identifiers
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2109-020-1252
Identifier Type: -
Identifier Source: org_study_id