MTX Hold During Covid-19 Booster
April 4, 2022 updated by: Eun Bong Lee, Seoul National University Hospital
Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Contact:
- Jina Yeo, MD
- Phone Number: 82-2-2072-2957
- Email: hi.thinmint@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females ≥ 19 years of age at time of consent
- Have a diagnosis of RA per ACR criteria
- Require methotrexate for RA treatment
- Subject to a Covid-19 booster vaccination
- Must understand and voluntarily sign an informed consent form including writing consent for data protection
Exclusion Criteria:
- Pregnant or lactating females
- Previous anaphylactic response to the vaccine components
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: MTX continue
Group will continue MTX after vaccination
|
MTX continuation
|
|
Experimental: MTX 1 week hold
Group will continue MTX for 1 week after vaccination
|
MTX continuation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Covid-19 antibody titer before and after Covid-19 vacciation
Time Frame: 2 weeks
|
Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
T cell activation after vaccination
Time Frame: 2, 4, 16 weeks
|
Percentage of activated T cells after vaccination
|
2, 4, 16 weeks
|
|
B cell activation after vaccination
Time Frame: 2, 4, 16 weeks
|
Percentage of activated b cells after vaccination
|
2, 4, 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Curtis JR, Johnson SR, Anthony DD, Arasaratnam RJ, Baden LR, Bass AR, Calabrese C, Gravallese EM, Harpaz R, Kroger A, Sadun RE, Turner AS, Williams EA, Mikuls TR. American College of Rheumatology Guidance for COVID-19 Vaccination in Patients With Rheumatic and Musculoskeletal Diseases: Version 3. Arthritis Rheumatol. 2021 Oct;73(10):e60-e75. doi: 10.1002/art.41928. Epub 2021 Aug 4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 29, 2021
Primary Completion (Anticipated)
December 30, 2022
Study Completion (Anticipated)
December 30, 2022
Study Registration Dates
First Submitted
December 28, 2021
First Submitted That Met QC Criteria
April 4, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
April 6, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2112-019-1279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.