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MTX Hold During Covid-19 Booster

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05313061
Recruitment Status : Recruiting
First Posted : April 6, 2022
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Eun Bong Lee, Seoul National University Hospital

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
Rheumatoid Arthritis Drug: MTX Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 29, 2021
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. T cell activation after vaccination [ Time Frame: 2, 4, 16 weeks ]
    Percentage of activated T cells after vaccination

  2. B cell activation after vaccination [ Time Frame: 2, 4, 16 weeks ]
    Percentage of activated b cells after vaccination



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05313061


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Eun Bong Lee, MD PhD    82-2-2072-3944    leb7616@snu.ac.kr   
Contact: Jina Yeo, MD    82-2-2072-2957    hi.thinmint@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Publications:
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Responsible Party: Eun Bong Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT05313061    
Other Study ID Numbers: H-2112-019-1279
First Posted: April 6, 2022    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases