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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
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 28, 2021
Last Updated
April 4, 2022
Sponsor
Seoul National University Hospital
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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
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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
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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
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MTX Hold During Covid-19 Booster

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