We would like to investigate if we can develop a biomarker test that enables us to identify patients that will respond to therapy or not before start of therapy. Research will be focused on ex vivo studies with whole blood that will be treated in…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important outcome will be the interindividual differences in gene
expression levels based on the ratio between untreated (t=0) and 24h/48h after
in vitro addition of the specific drug to the whole blood.
Secondary outcome
n/a
Background summary
Rheumatoid arthritis is a heterogenous disease, shown by differences in disease
activity, disease types and therapy responsiveness between patients. For
anti-TNF treatment, one of the most succesfull therapies in RA, 30% of patients
show no clinical improvement (ACR20). Similar findings are found for other
biological therapies. Up until now it is not known beforehand what patients
will benefit from therapy or not. As a result, some patients get unneccessary
expensive treatment without gaining improvement and other patients are excluded
from potential beneficial therapy.
Study objective
We would like to investigate if we can develop a biomarker test that enables us
to identify patients that will respond to therapy or not before start of
therapy. Research will be focused on ex vivo studies with whole blood that
will be treated in vitro with the specific drug. By gene expression profiling
we aim to investigate the in vitro response to the drug and translate this to
the farmacological differences that are seen between patients. This research
could lead to the identification of biomarkers that predict the responsiveness
of an indivual to certain therapy.
Study design
VUmc will develop an in vitro assay to determine the response of an individual
RA patient to certain biological therapy. Whole blood of RA patients will be
treated in vitro with a specific drug after which the cells will be isolated
and the mRNA expression profile will be determined.
The following conditions will be used:
1. Untreated, t=0h, t=24h and t=48h
2. Drug A, t=0h, t=24h, t=48h
Study burden and risks
The research will be performed with whole blood from RA patients that will be
drawn when the patients are in the clinic for blood collection anyway.
Therefore inconvenience is minimal.
de Boelelaan 1118
Amsterdam 1081HV
NL
de Boelelaan 1118
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
Patients with rheumatoid arthritis that have active disease and are selected to start with biological therapy (i.e. anti-TNF (etanercept, infliximab and adalimumab), rituximab, tocilizumab, abatacept or anakinra)
Exclusion criteria
Patients that have no active disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35405.048.11 |