to combine and validate diagnostic tests for the identification of preclinical very early RA (VERA) patients and prognostic tests for the prediction of progression
ID
Source
Brief title
Condition
- Autoimmune disorders
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be to develop a test or algorithm of multiple tests to
predict the development of RA in patients at risk.
Secondary outcome
Costeffectiveness of the (combination of) different tests compared to the
already existing tests, such as aCCP and RF.
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 identification of preclinical
very early RA (VERA) patients and prognostic tests for the prediction of
progression
Study design
We will conduct an observational study for 2 years.
Patients will be evaluated at 5 timepoints: at timepoint 0 , 6, 12, 18 and 24
months. 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.
Study burden and risks
Patient will be evaluated at 5 timepoints: at timepoint 0 and every 6 months
thereafter up until 24 months. At these timepoints a physical examination of
the joints will be performed. Furthermore the patient will receive three
questionnaires. Furthermore information on life style (eg smoking), family
history and current medication use will be gathered.
Blood will be drawn: at timepoint 0: 3 Paxgene tubes (each 2.5 ml), 1
coagulation tube (6 ml), 1 EDTA tube (6 ml) and 1 EDTA tube (5 ml), 2
heparinetubes (each 10 ml). At the other timepoints: 1 Paxgene tube (2.5 ml),
1 EDTA tube (5 ml) and 2 heparine tubes (each 10 ml). Apart from that, blood
will be drawn for clinical purposes, such as ESR, blood count, CRP, aCCP and
RF. Furthermore X-rays of hand and feet will be made at timepoint 0 and yearly
after that, in accordance with clinical practice. Urine will be collected and
stored. 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. The benefit for the
patient is an early diagnosis of RA.
High Tech Campus 84
Eindhoven 5656AG
NL
High Tech Campus 84
Eindhoven 5656AG
NL
Listed location countries
Age
Inclusion criteria
- 18-70 yrs
- Arthralgia
- Rheumatoid factor or aCCP positive or a first degree relative with rheumatoid arthritis.
Exclusion criteria
- arthritis, established by a rheumatologist
- other cause for arthralgia, such as ostheoarthritis, metabolic syndromes etc.
- received treatment with Disease Modifying Anti Rheumatic drugs previously
- received prednisone treatment, except from cortical or intranasal application, in the last 6 weeks for inclusion.
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 | NL40652.041.12 |