COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in immune mediated inflammatory disease (IMID) patients, with special attention for COVID-19

Completed

• Conditions: Immune mediated inflammatory diseases; autoimmune diseases; 10017969; 10003816; 10023213

• Registration Number: NL-OMON54899
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2200

Inclusion Criteria

- Clinical diagnosis of one of a least one of the following IMIDs: Rheumatoid
arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA),
psoriasis (PsO) or inflammatory bowel disease (IBD) (i.e. Crohns disease (CD)
or ulcerative colitis (UC).
- Age >= 16 years
- Using one or more immunomodulating agents (IA) in any dose (agents listed in
protocol)
- Not experiencing any clinical infection at time of inclusion
- Ability to read and communicate well in Dutch

Exclusion Criteria

- Use of the following immunomodulating agents in monotherapy and through
intravenous administration: rituximab, tocilizumab, abatacept.
- Use of glucocorticoids in monotherapy
- Not willing to be randomized into intervention or control condition.
- Not being able to be followed for 12 months, because of planned relocation or
short life expectancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is serious infection (resulting in hospitalization,<br /><br>intravenous antibiotics, admission to the intensive care or death) defined as<br /><br>Grade 3 or higher based on the Common Toxicity Criteria for Adverse Events. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes include: medication use, disease flares, adverse events and<br /><br>costs</p><br>