COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in IMID patients (COVID I2 study), with special attention for COVID 19: a pragmatic, explorative randomized controlled trial
- Conditions
- <p>Rheumatoid arthritis<br />Psoriatic arthritis<br />Axial spondyloarthritis<br />Immune mediated inflammatory diseases<br />Inflammatory rheumatic diseases</p>10003816
- Registration Number
- NL-OMON22848
- Lead Sponsor
- Sint Maartenskliniek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2200
- Clinical diagnosis of at 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 of the following immunomodulating agents (IA) from table 1 in any dose. Monotherapy rituximab and glucocorticoids are exempts because rituximab cannot be stopped due to long half-life time and post pharmacokinetic effects on b-cell depletion, and glucocorticoids because stopping is associated with secondary hypocortisolism. - Not experiencing any clinical infection at time of inclusion (based on check in electronic health record and as reported by patient at inclusion). - Ability to read and communicate well in Dutch
- Use of the following immunomodulating agents in monotherapy and through intravenous administration: rituximab, tocilizumab or abatacept. This because the contrast between stopping and continuation is expected to be low, as the treatment intervals are high, and intravenous medication is not easily provided in case of hospital admission. - Use of glucocorticoids (GC) in monotherapy, because stopping of GC is not feasible due to risk of GC use induced hypocortisolism - Not willing to be randomized to either 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>Proportion of participants with a serious infection, i.e. grade 3 or higher (according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0).</p><br>
- Secondary Outcome Measures
Name Time Method