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

Inflammatory Bowel Diseases Clinical Trial

— COV-ADA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05706038
• Other study ID #: COV-ADA
• Status: Completed
• Start date: April 27, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: January 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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: 1. Adalimumab withdrawal in patients with IBD 2. Adalimumab continuation in patients with IBD 3. Adalimumab withdrawal in patients with RA, PsA, axSpA, and nrxSpA 4. Adalimumab continuation in patients with RA, PsA, axSpA, and nrxSpA n = 312 subjects for groups 1+3 together and 312 subjects for groups 2+4 together. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. age = 18 years

2. diagnosis of immune-mediated inflammatory disease:

1. IBD: CD, UC or undetermined colitis

2. Rheumatic diseases: RA, PsA, axSpA, and nrx SpA

3. patients treated with adalimumab for IMID at time of SARS-CoV-2 infection diagnosis

4. COVID-19 positive PCR test

5. minimum treatment duration on adalimumab of 3 months before SARS-CoV-2 infection diagnosis

6. minimum follow-up of one month after SARS-CoV-2 infection diagnosis

Exclusion Criteria:

1. Adalimumab withdrawal for other reasons than SARS-CoV-2 infection

2. Patients with COPD or lung co-morbidities

3. Pregnant, parturient, or breastfeeding woman

4. Minor person (non-emancipated)

5. Adult person under legal protection (any form of public guardianship)

6. Adult person incapable of giving consent and not under legal protection

7. 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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

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.

Locations

Country	Name	City	State
Italy	Irccs Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	from diagnosis of SARS-CoV-2 infection to enrollment