Immune mediated inflammatory diseases
Conditions
Interventions
The intervention consists of continued IA treatment and the control condition
is interruption of IA treatment until the infection is resolved, all in
addition to standard of care.
Sponsors
Sint Maartenskliniek
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is serious infection (resulting in hospitalization, intravenous antibiotics, admission to the intensive care or death) defined as Grade 3 or higher based on the Common Toxicity Criteria for Adverse Events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include: medication use, disease flares, adverse events and costs | — |
Countries
Netherlands
Outcome results
None listed