Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse

Sponsor
IRCCS San Raffaele
Study ID
NCT05706038
Status
Completed

Conditions

  • Inflammatory Bowel Diseases
  • Rheumatic Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab is a fully human, high-affinity, recombinant anti-tumor necrosis factor (TNF) alpha monoclonal antibody used to treat rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis, etc. Adalimumab is a fully human, high-affinity, recombinant immunoglobulin G (IgG) anti-TNF alpha monoclonal antibody. It is a molecule comprising 1330 amino acids and has a molecular weight of approximately 148 kDa.\[4\] It inhibits the binding of TNF alpha (both soluble and membrane-bound) to its receptor. Specifically, it inhibits TNF alpha's interaction with p55 (TNFR1) and p75 (TNFR2) cell surface TNF receptors, which in turn interferes with cytokine-driven inflammatory processes. It is identical in structure and function to the naturally occurring human IgG1 and thus has high selectivity for TNF alpha and has low immunogenic potential.

Study Details

This study is a retrospective pharmacological study, of a historical cohort. Collection of Retrospective data from February 2020 to 30 September 2021 The index date is the date of COVID-19 positive PCR test. The data will be collected until last news (last clinical visit or death). There are no defined study visits. In the course of the study, the clinical data recorded are those corresponding to the standard medical procedure. The goal of this study is to assess the impact on continuing or stopping adalimumab treatment on the occurrence of a severe COVID-19 (Coronavirus Disease 2019) in patients with Immune-Mediated Inflammatory Disease (IMID), during the first month after the diagnosis of SARS-CoV-2 infection. To our knowledge, no comparisons have been performed between IMID patients stopping or not their maintenance treatment. In the context of the COVID-19 epidemic, the goal is to minimize the risk of disease flare while simultaneously minimizing the risk of severe COVID-19. In this study, we hypothesized that patients treated by adalimumab for IMID might not be susceptible to severe COVID-19 disease course.

Key Dates

Start date
Apr 27, 2022
Status verified
Jan 2023
Primary completion
Oct 31, 2022
Completion
Oct 31, 2022

Study Design

Enrollment
49 participants (actual)

Primary Outcome Measure

composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death [ Time Frame: first month after the diagnosis of SARS-CoV-2 infection ]

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