to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients with reumatoid artritis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Response to treatment with biologics in patients with RA, based on EULAR and
ACR response criteria.
Prediction of response via in vitro assays
1) ACPA profiling
2) cytokine, chemokine and adipokine profiling
3) (epi) genetic profiling
Secondary outcome
Cost effectiveness of (combinations of) in vitro tests in predicting response
to biological treatment compared to existing tests such as RF and aCCP
Background summary
Rheumatoid arthritis (RA) is a heterogenous disease in which joint inflammation
leads to structural irreversible joint damage, with as a consequence disability
and serious loss of quality of life. Early timing of treatment is essential for
the final outcome and therefore an early diagnosis is crucial.
Study objective
to combine and validate diagnostic tests for the prediction of clinical
response to therapy with biologics in patients with reumatoid artritis.
Study design
We will conduct an observational study for 3-4 mo. Patients will be evaluated
at 3 timepoints: at timepoint 0 and 3-6 weeks and 3-4 months after start with
biological treatment. At these timepoints a physical examination of the joints
will be performed. Furthermore the patient will receive three questionnaires
and blood will be drawn. X-rays of hand and feet will be made at timepoint 0
and yearly after that (latter during routine visits).
At each time point blood will be drawn for clinical purposes (daily practice),
such as ESR, blood count, CRP, aCCP and RF (25 ml). For research purposes extra
blood will be drawn: at timepoint 0: 2 Paxgene tubes (each 2.5 ml, for RNA), 1
coagulation tube (10 ml, for serum), 2 EDTA tubes (6 ml; for plasma and DNA), 2
heparinetubes (each 10 ml, for PMBCs). Urine will be collected. At the other
timepoints: 1 Paxgene tube (2.5 ml), 1 EDTA tube (6 ml), 1 coagulation tube (10
ml) and 2 heparine tubes (each 10 ml). Urine will be collected.
Study burden and risks
Patient will be evaluated at 3 timepoints: At these timepoints a physical
examination of the joints will be performed. Furthermore the patient will
receive three questionnaires and blood will be drawn (+/_ 45 ml) timepoint.
The burden of participation relies mainly on extra blood draws and filling in
the questionnaires. Apart from possible small side effects of the blood draw,
no risks are involved. Patients do not directly benefit from participation.
High Tech Campus 84
Eindhoven 5656AG
NL
High Tech Campus 84
Eindhoven 5656AG
NL
Listed location countries
Age
Inclusion criteria
Patients with established rheumatoid arthritis who are starting treatment with a biological (anti-TNFa, anti-IL-6, B cel inhibition or anti-costimulatory therapie)
Exclusion criteria
-patients with another rheumatological disease, that requires treatment with a biological
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 | NL41030.041.12 |