to combine and validate diagnostic and prognostic tests for patients with recently diagnosed rheumatoid arthritis to predict joint damage and response to (DMARD) therapy.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To test the predictive value of different tests, individually and combined, on
the prognosis and respons to therapy in early reumatoid arthritis patients.
- ACPA antibodies
- cytokine, chemokine, adipokine profiling
- (epi)genetic markers
Secondary outcome
Cost-effectiveness of these new tests and combinations of these tests to
predict prognosis and response to therapy compared to existing tests like RF.
Background summary
Rheumatoid arthritis (RA) is a heterogeneous disease in which joint
inflammation leads to structural irreversible joint damage, with as a
consequence disability and serious loss of quality of life. Early treatment has
been shown to prevent or delay joint damage. However, which patients are at
risk of developing joint damage remains largely unknown. Furthermore, up until
now, no test is available to predict the response to different therapy
strategies currently used in the treatment of rheumatoid arthritis.
Study objective
to combine and validate diagnostic and prognostic tests for patients with
recently diagnosed rheumatoid arthritis to predict joint damage and response to
(DMARD) therapy.
Study design
We will conduct an observational study for 2 years.
Patients will be evaluated at 3 time points: at baseline and at 12 and 24
months. At these time points a physical examination of the joints will be
performed. Furthermore the patient will receive three questionnaires.
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 time point 0: 3 Paxgene tubes (each 2.5 ml, for RNA), 2
coagulation tubes (10 ml, for serum), 1 EDTA tube (6 ml; for plasma) and 1 EDTA
tube (10 ml, for DNA), 2 heparin tubes (each 10 ml, for PMBCs). Urine will be
collected. At the other time points: 1 Paxgene tube (2.5 ml), 1 EDTA tube (5
ml), 1 coagulation tube (10 ml) and 2 heparine tubes (each 10 ml). Urine will
be collected. Three questionnaires regarding their health and economic
consequences of their disease will be filled in by patients at all three time
points.
Study burden and risks
The burden of participation relies mainly on extra blood draws and filling in
the questionnaires. The risk is considered minimal. 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
Recently diagnosed reumatoid arthritis patients who have not been treated yet with disease modifying antirheumatic drugs (DMARDs).
Exclusion criteria
- rheumatic disease, other than rheumatoid arthritis
- patients previously treated with DMARDs
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 | NL41029.041.12 |