MTX Hold During Covid-19 Booster
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MTX
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
MTX continue
MTX 1 week hold
Arm Description
Group will continue MTX after vaccination
Group will continue MTX for 1 week after vaccination
Outcomes
Primary Outcome Measures
Covid-19 antibody titer before and after Covid-19 vacciation
Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
Secondary Outcome Measures
T cell activation after vaccination
Percentage of activated T cells after vaccination
B cell activation after vaccination
Percentage of activated b cells after vaccination
Full Information
NCT ID
NCT05313061
First Posted
December 28, 2021
Last Updated
April 4, 2022
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05313061
Brief Title
MTX Hold During Covid-19 Booster
Official Title
Effect of One-week Discontinuation of Methotrexate on Immunogenicity of COVID-19 Booster Vaccination in Patients With Rheumatoid Arthritis: A Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the effect of MTX discontinuation for 1 week on vaccination response to Covid-19 booster vaccination in RA patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MTX continue
Arm Type
Active Comparator
Arm Description
Group will continue MTX after vaccination
Arm Title
MTX 1 week hold
Arm Type
Experimental
Arm Description
Group will continue MTX for 1 week after vaccination
Intervention Type
Drug
Intervention Name(s)
MTX
Intervention Description
MTX continuation
Primary Outcome Measure Information:
Title
Covid-19 antibody titer before and after Covid-19 vacciation
Description
Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
T cell activation after vaccination
Description
Percentage of activated T cells after vaccination
Time Frame
2, 4, 16 weeks
Title
B cell activation after vaccination
Description
Percentage of activated b cells after vaccination
Time Frame
2, 4, 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Bong Lee, MD PhD
Phone
82-2-2072-3944
Email
leb7616@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jina Yeo, MD
Phone
82-2-2072-2957
Email
hi.thinmint@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29572291
Citation
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.
Results Reference
background
PubMed Identifier
28468794
Citation
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.
Results Reference
background
PubMed Identifier
34346564
Citation
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.
Results Reference
background
Learn more about this trial
MTX Hold During Covid-19 Booster
We'll reach out to this number within 24 hrs