to combine and validate diagnostic tests for the prediction of clinical response to therapy with biologics in patients withreumatoid artritis.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Validation of prognostic tests, based on serological, cellular and molecular
markers, as well as several imaging techniques, to predict the response to
treatment and to predict disease severity and joint damage
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 6 months. Patients will be evaluated
at 4 timepoints: at timepoint 0 and 4,16 and 26 weeks 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.
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.
Timepoint 0: 2 Paxgene tube (2.5 ml), 2 coagulation tubes (5 ml), 2 EDTA buizen
( 6 ml), 2 heparin tubes (10 ml).
Timepoint 4 en 14 weeks: 1 Paxgene tube (2.5 ml), 2 coagulation tubes (5 ml),
2 EDTA tubes ( 6 ml), 2 heparin tubes (10 ml).
Timepoint 26 weeks: 1 Paxgene tube (2.5 ml), 2 coagulation tubes (5 ml), 1 EDTA
tube (6 ml)
Study burden and risks
Patient will be evaluated at 4 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.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
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 | NL58582.048.16 |