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Completed

NCT Number: NCT05069714

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Infections Influenza Influenza, Human Joint Diseases Musculoskeletal Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rheumatic Diseases Skin and Connective Tissue Diseases Vaccine Reaction Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National Univ. Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 writing consent for data protection
  • Stable doses of methotrexate over the preceding 6 weeks

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 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

Treatment and study plan

MTX-hold

Drug

Temporary discontinuation of methotrexate for 1 or 2 weeks

Primary outcomes

  1. Proportion of satisfactory vaccine response

    Time frame: 4 weeks

    as ≥ 4-fold increase in post-vaccination titer in ≥ 2 of 4 influenza strains at 4 weeks after vaccination

Secondary outcomes

  1. Proportio0n of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains

    Time frame: 4 weeks and 16 weeks

    Proportion of patients who have ≥ 4-fold increase in post-vaccination titer in ≥ 3 of 4 influenza strains at 4 weeks and 16 weeks after vaccination

  2. Proportion of seroprotection for each strain

    Time frame: 4 weeks and 16 weeks

  3. Change from baseline in titer (in GMT)

    Time frame: 4 weeks and 16 weeks

  4. Change from baseline in DAS28-4 (CRP)

    Time frame: 4 weeks and 16 weeks

  5. Disease flare

    Time frame: 4 weeks and 16 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of One-week vs Two-week Discontinuation of Methotrexate on Efficacy of Seasonal Influenza Vaccination in Patients With Rheumatoid Arthritis: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 6, 2021
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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