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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UNKNOWN
NA
318 participants
INTERVENTIONAL
2016-09-30
2017-08-31
Brief Summary
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Detailed Description
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However, low dose of glucocorticoids, conventional DMARDs and biological DMARDs including tumor necrosis factor inhibitors have been reported to substantially decrease vaccine response (4); MTX has been reported to be associated with a decreased response to seasonal influenza vaccination by up to 15%.
To optimize a vaccine response, vaccination should be administrated before the treatment with immunesuppressive medications is initiated. However, most patients with RA are already on stable dose of MTX at the time of when vaccinations. To improve the vaccine response, a short term discontinuation of MTX could be considered. In a prior study, we discovered that a temporary discontinuation of MTX for 4 weeks during peri-vaccination period tended to be associated with an improved response to vaccination with trivalent influenza vaccination (Figure 1). It remains to be defined whether MTX discontinuation for shorter period increases the vaccination efficacy while minimizing the RA flare rate.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: MTX continue
Group will continue MTX after vaccination
Methotrexate
Group 2: MTX hold
will hold MTX for 2 weeks after vaccination
Methotrexate
Interventions
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Methotrexate
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
* Previous vaccination with any live vaccine 4 weeks before or any inactivated vaccine 2 weeks before the study
* Blood transfusion within 6 months
* Active rheumatoid arthritis necessitating a recent change in the drug regimen
* 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
18 Years
65 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Eun Bong Lee
Professor
Locations
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Seoul National Univ. Bundang Hospital
Bundang, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, Seoul, South Korea
Countries
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Facility Contacts
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Yun Jong Lee, MD PhD
Role: primary
Eun Bong Lee, MD PhD
Role: primary
Hyun Mi Kwon, MD
Role: backup
Kichul Shin, MD PhD
Role: primary
References
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Park JK, Choi Y, Winthrop KL, Song YW, Lee EB. Optimal time between the last methotrexate administration and seasonal influenza vaccination in rheumatoid arthritis: post hoc analysis of a randomised clinical trial. Ann Rheum Dis. 2019 Sep;78(9):1283-1284. doi: 10.1136/annrheumdis-2019-215187. Epub 2019 Mar 23. No abstract available.
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.
Other Identifiers
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SNUH-IMJ-003
Identifier Type: -
Identifier Source: org_study_id