Authorised Therapeutic use (Phase IV) Inflammatory rheumatic disease

Vaccination against respiratory syncytial virus in patients with inflammatory rheumatic diseases. The impact of anti-rheumatic treatments on the RSV immune response.

EU CTIS ID: 2024-518191-31-00

What this study is testing

The primary objective of this trial is to assess if immunomodulating antirheumatic treatments including synthetic disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate and different biological treatments (anti-TNF, anti IL6r, anti-IL12/23/17, anti-CD20, anti-BlyS, or targeted DMARDs (JAK-inhibitors)) impair the humoral immune response to one dose of RSV vaccine in IRD patients compared to immunocompetent controls.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • The subject has given their written consent to participate in the trial.
  • Age ≥60 years.
  • Having regular follow-up at rheumatology department in Lund, Malmö or Kristianstad
  • Receiving immunomodulating treatment for at least 3 months (only for patients)

You likely can't join if

  • Immunodeficiency (not related to immunomodulating antirheumatic treatment)
  • Changes of immunomodulating treatment four weeks before the vaccination
  • Not willing to get vaccinated against RSV
  • Prior vaccination against RSV
  • Fever or ongoing infection
  • Hypersensitivity to the active substances or to any of the excipients of both RSV vaccines (Abrysvo and Arexvy).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.