An observational study in Inflammatory Bowel Diseases and Rheumatic Disorder, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by IRCCS San Raffaele · Observational
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.
Immune-mediated inflammatory disease (IBD or rheumatic disease) patients treated with adalimumab with positive PCR COVID-19 diagnosis will be enrolled by physicians.
There will be four predefined and balanced group:
All data will be described by percentages (categorical variables) and mean +/- standard deviation and quartiles (continuous variables). The median time of follow-up survival data will also be detailed for each event of interest (admission to intensive care unit, need to a mechanical ventilation during hospitalization, death). Kaplan Meier curve will describe the probability of the occurrence of a severe SARS-CoV-2 infection (see primary endpoint for definition).
Time to analysis - better define - time to severity of the event. Occurrence (yes/no)
1,487 studies on the registry are indexed under Inflammatory Bowel Diseases; 434 are open to participants now.
This study's enrollment of 49 is below the median of 146 across 659 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →IRCCS San Raffaele is the lead sponsor of 450 studies on the registry; 234 are open to participants now.
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Retrospective pharmacological study of a historical cohort: retrospective data from February 2020 to September 2021.
Immune-mediated inflammatory disease (IBD or rheumatic disease) patients treated with adalimumab with positive Polymerase Chain Reaction (PCR) COVID-19 diagnosis.
624 patients will be needed (of whom 312 with maintenance of treatment).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
diagnosis of immune-mediated inflammatory disease:
Exclusion Criteria:
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.
composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death
The primary endpoint is the occurrence of a severe SARS-CoV-2 infection, which will be defined by a composite endpoint: occurrence of an admission to intensive care unit and/or need to a mechanical ventilation during hospitalization and/or death, during the first month after the diagnosis of SARS-CoV-2 infection.
Time frame: first month after the diagnosis of SARS-CoV-2 infection
occurrence of IMID flare
to measure the occurrence of IMID flare, which will be assessed by the occurrence of a disease flare until last clinical visit, to evaluate risk factors for severe COVID-19, and to evaluate risk factors for IMID flare. IMID flare is defined by patient requiring medical intervention (additional treatment and/or dose escalation and/or surgery and/or hospitalization).
Time frame: from diagnosis of SARS-CoV-2 infection to enrollment
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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