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

NCT05706038 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2023-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Inflammatory Bowel Diseases
  • Rheumatic Disorder

Interventions

DRUG

Adalimumab

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Silvio Danese · IRCCS San Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-27
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05706038 on ClinicalTrials.gov