One or Two Week Methotrexate Discontinuation on Efficacy of Influenza Vaccination in Rheumatoid Arthritis.

Last updated: December 14, 2022
Sponsor: Seoul National University Hospital
Overall Status: Completed

Phase

3

Condition

Influenza

Rheumatoid Arthritis

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT05069714
2109-020-1252
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (MTX) discontinuation for 1 week is non-inferior to MTX discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females ≥ 19 years of age at time of consent
  • Have a diagnosis of RA per ACR criteria
  • Must understand and voluntarily sign an informed consent form including writingconsent for data protection
  • Stable doses of methotrexate over the preceding 6 weeks

Exclusion

Exclusion Criteria:

  • Pregnant or lactating females
  • Previous anaphylactic response to vaccine components or to egg.
  • Acute infection with T >38°C at the time of vaccination
  • History of Guillain-Barre syndrome or demyelinating syndromes
  • Blood transfusion within 6 months
  • Any other rheumatic disease such as systemic lupus erythematosus, mixed connectivetissue disease, dermatomyositis/polymyositis, and vasculitis except for secondarySjogren's disease
  • Any condition including laboratory abnormality which places the subject atunacceptable risk
  • Subjects who decline to participate

Study Design

Total Participants: 184
Study Start date:
October 01, 2021
Estimated Completion Date:
September 30, 2022

Connect with a study center

  • Seoul National Univ. Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

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