Spondyloarthropathy Clinical Trial
Official title:
Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents
The objective of the study is to investigate extra-articular manifestations, pain mechanisms, patient-reported outcomes, comorbidities and association between these conditions in patients with spondyloarthropathy (SpA) treated with Biologics. Further, to assess the predictive value of baseline pain profile on treatment outcome after ≥ 3 months.
Patients with spondyloarthropaty, who initiate or switch biologics in routine care due to an
active disease state, will be enrolled in this observational study.
The overall aim is to investigate extra-articular manifestations, pain mechanisms and
patient-reported outcomes and elucidate if these factors - independently or by interaction -
influence treatment response after ≥ 3 months. Patients will have a baseline visit, an eye
examination and a follow up visit after ≥ 3 months. Clinical examinations will be performed
at both time points and include:
1. Clinical examination (the spinal movement)
2. Assessment of pain mechanisms by clinical evaluation (BASDAI, tender points,) and pain
questionnaires (PainDETECT).
3. The SPARCC Enthesitis Index will be used to enthesitis count.
4. Interview and questionnaires regarding lifestyle, comorbidity, function and quality of
life
5. Blood samples
6. Urine samples
7. Stool samples
Clinical as well as patient-reported and observer-based outcomes will be described for the
overall study population and the prognostic influence of extra-articular manifestations,
comorbidity and pain mechanisms will be analysed.
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