1) To assess the effect of continuation of IA treatment in IMID patients during an infection compared to temporary interruption of the IA treatment with regard to serious infection.2) to study the incidence and risk factors for infection in IMID…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
Secondary outcomes include: medication use, disease flares, adverse events and
costs
Background summary
Immunomodulatory agents (IA) are widely used (>200,000 patients in the
Netherlands) for the treatment of patients with immune-mediated inflammatory
diseases (IMIDs) including rheumatoid arthritis, psoriatic arthritis, axial
spondylarthritis, psoriasis and inflammatory bowel disease, and they are in
general associated with a modestly increased risk of infection. However, it is
not clear what risk factors for infection are, and whether it is wise to
temporary interrupt IA treatment during an infection. Recently, the COVID-19
pandemic has dramatically increased the urgency to provide answers to these
questions, especially since, surprisingly, some IA seem to be effective
treatment against COVID-19.
Study objective
1) To assess the effect of continuation of IA treatment in IMID patients during
an infection compared to temporary interruption of the IA treatment with regard
to serious infection.
2) to study the incidence and risk factors for infection in IMID patients using
IA, with special attention for COVID-19.
Study design
This study is a two arm, open-label, pragmatic, explorative randomized
controlled superiority strategy study, among IMID patients using IA in the
Netherlands.
Intervention
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.
Study burden and risks
This collaborative project will provide evidence informing many care providers
potentially leading to improved patient outcomes (shorter/less severe
infections) and improved cost-effectiveness (less prolonged
infection/hospitalization/death). Participants will be burdened with several
questionnaires during 12 months, and a small risk/chance of a more/less severe
infection when randomised to a possibly inferior/superior treatment strategy.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL73479.091.20 |
| OMON | NL-OMON22848 |