NCT02948608

Clinical Characteristics of Importance to Outcome in Patients With Spondyloarthritis

Effectiveness and Patient-reported Outcomes in Patients With Spondyloarthropathies Treated With Biological Agents

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Svendborg Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Spondyloarthropathy

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-03-31
• Completion: 2019-09-30
• First posted: 2016-10-28
• Last updated: 2019-03-07

Locations

1 site across 1 country: Denmark