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

NCT05706038 | Completed

• 1 other identifier: COV-ADA
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  first month after the diagnosis of SARS-CoV-2 infection

Secondary Outcomes (1)

• occurrence of IMID flare

  from diagnosis of SARS-CoV-2 infection to enrollment

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• age ≥ 18 years
• diagnosis of immune-mediated inflammatory disease:
• IBD: CD, UC or undetermined colitis
• Rheumatic diseases: RA, PsA, axSpA, and nrx SpA
• patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis
• COVID-19 positive PCR test
• minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis
• minimum follow-up of one month after SARS-CoV-2 infection diagnosis

You may not qualify if:

• Adalimumab withdrawal for other reasons than SARS-CoV-2 infection
• Patients with COPD or lung co-morbidities
• Pregnant, parturient, or breastfeeding woman
• Minor person (non-emancipated)
• Adult person under legal protection (any form of public guardianship)
• Adult person incapable of giving consent and not under legal protection
• Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1 of the Public Health Code.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

Irccs Ospedale San Raffaele

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Silvio Danese

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: January 31, 2023
• Study Start: April 27, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

IT (1)