To investigate ex-vivo cytokine profiling and several other determinants before the start of treatment with abatacept, adalimumab, etanercept, rituximab and tocilizumab as a predictor of individual treatment response after 3 months of treatment in…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the European League against Rheumatism (EULAR) good response
criteria (DAS28CRP <= 3.2, and *DAS28CRP > 1.2 compared to baseline), 3 months
after the start of treatment with one of the above biologics.
Secondary outcome
Secondary outcomes include the *DAS28CRP compared to baseline and the ACR/EULAR
remission criteria, 3 and 6 months after the start of treatment with one of the
above biologics.
Background summary
Rheumatoid arthritis (RA) is characterized by heterogeneity in its clinical
manifestations, pathological features and response to treatment. Clinical
studies reveal that approximately 60% of RA patients do not achieve good
clinical response after 6 months of treatment with a biologic. Moreover,
individual treatment response cannot be predicted. Given the detrimental
effects on quality of life and the destructive nature of RA, it would be
desirable to predict, before the start of treatment, the (biologic) DMARD with
the highest chance of good response in a RA patient. This would improve timely
disease control. So far, studies have failed to consistently identify a single
or set of biomarkers that can predict individual treatment response. In this
study, we will investigate several determinants before the start of treatment
with a biologic as a predictor of individual treatment response after 3 months
of treatment in RA patients. One of the determinants will be ex-vivo
(un)stimulated and inhibited cytokine profiling, since this is in our view a
promising candidate predictor and has not been investigated before. In
particular, performing ex-vivo cytokine profiling in blood samples inhibited by
a biologic seems promising, since this closely resembles the actual drug effect
in RA patients.
Study objective
To investigate ex-vivo cytokine profiling and several other determinants before
the start of treatment with abatacept, adalimumab, etanercept, rituximab and
tocilizumab as a predictor of individual treatment response after 3 months of
treatment in RA patients.
Study design
This is a prospective longitudinal prediction cohort study.
Study burden and risks
There will be minimal burden for the patients participating in this study,
because blood samples will only be obtained at baseline. Moreover, measurement
of the DAS28CRP is already performed in usual care, during the regular
outpatient clinic visits every 3 months. The results of our study will have no
direct implications for the treatment or prognosis of the individual patients,
as the results of the baseline tests will be blinded until after treatment
response is assessed.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
• Rheumatoid arthritis (either 2010 ACR RA and/or 1987 RA criteria and/or clinical diagnosis of the treating rheumatologist, fulfilled at any time point between start of the disease and inclusion)
• Patients with RA who start with (or switch to) a biologic (including abatacept, adalimumab, etanercept, rituximab and tocilizumab)
• Concomitant treatment with conventional DMARDs and/or NSAIDs is permitted
• Age >= 18 years
• Informed consent
• Ability to measure the study outcome in the patient (e.g. life expectancy >6 months, no planned relocation far away)
• Ability to read and communicate well in Dutch
Exclusion criteria
None
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 | NL47946.091.14 |
| OMON | NL-OMON26414 |