← Back to all trials
Completed
NCT05706038
Impact of Adalimumab Withdrawal or Continuation on Severity of COVID-19 and Risk of IMID Relapse
Conditions: Inflammatory Bowel Diseases, Rheumatic Disorder
Sex: All
Ages: 18 Years – N/A
Enrollment: 49
Sponsor: IRCCS San Raffaele
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:age ≥ 18 yearsdiagnosis of immune-mediated inflammatory disease:IBD: CD, UC or undetermined colitisRheumatic diseases: RA, PsA, axSpA, and nrx SpApatients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosisCOVID-19 positive PCR testminimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosisminimum follow-up of one month after SARS-CoV-2 infection diagnosisExclusion Criteria:Adalimumab withdrawal for other reasons than SARS-CoV-2 infectionPatients with COPD or lung co-morbiditiesPregnant, parturient, or breastfeeding womanMinor person (non-emancipated)Adult person under legal protection (any form of public guardianship)Adult person incapable of giving consent and not under legal protectionPerson 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.
Source: ClinicalTrials.gov (NCT05706038). StuddyBuddy aggregates publicly available trial information.
