Spondyloarthropathy
Conditions
Keywords
spondyloarthropathy, ankylosing spondylitis, spinal diseases, spondylitis, spondylarthritis, psoriasis, uveitis, joint diseases
Brief 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.
Interventions
None listed
Sponsors
Odense University Hospital
Parker Research Institute
Spine Centre of Southern Denmark
Svendborg Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with SpA * ≥18 years of age at time of consent * Ability and willingness to give written informed consent and to meet the requirements of this protocol * Patients must have a history of active disease and a BASDAI \>40 (10-100) or elevated C-reactive protein, despite current or previous NSAIDs therapy
Exclusion criteria
* Age \< 18 years * No consent * Pregnancy * Active or latent TB * Diagnosed Human immunodeficiency virus * Diagnosed hepatitis * Current or past malignant disease * Recurrent or chronic infection (viral, fungal or bacterial) * Multiple sclerosis * Heart failure (NYHA class III/IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankylosing Spondylitis Disease Activity Index BASDAI 50 % | ≥ 3 month from baseline | composite measures of improvement in disease state (50% improvement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) | ≥ 3 month from baseline | composite measures of improvement in disease state |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Bath Akylosing Spondylitis Functional Index (BASFI) | ≥ 3 month from timeline | — |
| Change in Spondylitis Consortium of Canada enthesitis score (SPARCC) | ≥ 3 month from baseline | — |
| Change in score of Medical Outcomes Study Questionnaire (SF-36) for mental and physical Health | ≥ 3 month from baseline | — |
| Change in plasma calprotectin (microg/L) | ≥ 3 month from baseline | — |
| Change in the Simple Clinical Colitis Activity Index (SCCAI) | ≥ 3 month from baseline | composite measures of improvement in disease state |
| Change in the Harvey Bradshaws Activity Index (HBAI) | ≥ 3 month from baseline | composite measures of improvement in disease state (Crohns disease) |
| To analyse the influence of PDQ score on the treatment response | ≥ 3 month from baseline | we analyse if the painDETECT questionnaire score (PDQ) at baseline can influence on treatment outcome |
| Change in C-Reactive Protein, CRP (mg/L) | ≥ 3 month from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue | ≥ 3 month from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of fatigue of pain | ≥ 3 month from baseline | — |
| Change in Visual Analogue Scale (VAS) (0-100 mm) of global disease impact | ≥ 3 month from baseline | — |
| Withdrawal of treatment due to adverse event during the study period | ≥ 3 month from baseline | — |
| Change in fecal calprotectin (mg/kg) | ≥ 3 month from baseline | — |
| Characterisation of the extra-articular manifestations in SpA patients | at baseline and ≥ 3 months from baseline | To characterise the extra-articular manifestations according to ASAS criteria |
Countries
Denmark
Outcome results
None listed