1) To detect undiagnosed clinical SpA in First degree relatives (FDRs)2) To identify biomarker alterations in subclinical SpA3) To investigate prospectively which individuals will develop clinical SpA over time and correlate that to the baseline…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identify and validate biomarkers which can give more insight in the
pathofysiology and (early) diagnosis of SpA
Secondary outcome
Create a biobank with biological samples and clinical data to find new
biomarkers in SpA patients with future techniques.
Background summary
Spondylarthropathy (SpA ) is second most common form of chronic inflammatory
arthritis. It affects young adults between 20-40 years of age. This disease can
lead to impairement in daily activity, due to inflammation of the peripheral
and axial joints, ankylosis and joint erosions. Due to insidious onset, early
symptoms are often missed, leading to a diagnostic delay of more than 10 years.
Thanks to the early referral strategies and the introduction of MRI, this delay
is reduced to 5-6 years, however, this is still far too long.
Therefore we would like to apply and integrate all knowledge of this disease on
early SpA, to healthy individuals at risk of developing SpA. Therefore we chose
to look into first degree relatives (FDRs) since we know that the recurrence
risk is much higher than non relatives. An HLA-B27 positive FDR has a
recurrence risk of 30-40%.
Study objective
1) To detect undiagnosed clinical SpA in First degree relatives (FDRs)
2) To identify biomarker alterations in subclinical SpA
3) To investigate prospectively which individuals will develop clinical SpA
over time and correlate that to the baseline clinical and
biological features
Study design
-Observational prospective cohort of 5 years, where FDRs are followed up yearly
for 5 years.
Study burden and risks
- A total of 6 study visits are planned in five years. An seperate MRI date will be planned if we are not able to perform MRI on same date as first appointment. If participants have complaints (back pain, arthritis), an extra unscheduled visit will be planned and maybe another MRI will take place in case of back pain >3 months. - A questionnaire will be held during each visit, with a duration of 15 minutes, containing questions about complaints and impairments. - A total of 6x blood will be drawn (and also extra time during an unscheduled visit, if applicable). The total amount of blood drawn at first visit will be around 48 mL (9 tubes) and for the other visits 24 mL per visit (5 tubes). - Three times during the study, X-rays will be made of Barsony, lumbar and cervical spine. The total radiation amount is 4.6 mSv. In case of an unscheduled visit (new back pain >3 months) extra series will be made, which lead to a total radiation amount of 6.9 mSv.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- First degree relative of an HLA-B27 positive Ankylosing Spondylitis
(Bechterew) patient
- Age at inclusion 18-40 years
Exclusion criteria
- Established diagnosis of sponyloarthritis
- Concomitant conditions that impact participation
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL41248.018.12 |