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MTX Hold During Covid-19 Booster

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05313061
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 29, 2021
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: MTX continue

Group will continue MTX after vaccination

Drug: MTX
MTX continuation
Experimental: MTX 1 week hold

Group will continue MTX for 1 week after vaccination

Drug: MTX
MTX continuation

Outcome Measures

Primary Outcome Measures

  1. Covid-19 antibody titer before and after Covid-19 vacciation [2 weeks]

    Titer and geometric mean titers (GMTs) of neurolizing antibody after vaccination

Secondary Outcome Measures

  1. T cell activation after vaccination [2, 4, 16 weeks]

    Percentage of activated T cells after vaccination

  2. B cell activation after vaccination [2, 4, 16 weeks]

    Percentage of activated b cells after vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Hospital Seoul Korea, Republic of 03080

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eun Bong Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05313061
Other Study ID Numbers:
  • H-2112-019-1279
First Posted:
Apr 6, 2022
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 6, 2022