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

Sint Maartenskliniek0 个研究点目标入组 2,200 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•- 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.

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