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| ID | Type | Description | Link |
|---|---|---|---|
| R-144-A4136 | Other Grant/Funding Number | The Danish Rheumatism Association |
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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
| Parker Research Institute | OTHER |
| Spine Centre of Southern Denmark | OTHER |
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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:
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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| Measure | Description | Time Frame |
|---|---|---|
| Ankylosing Spondylitis Disease Activity Index BASDAI 50 % | composite measures of improvement in disease state (50% improvement) | ≥ 3 month from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankylosing Spondylitis Disease Activity Score (ASDAS) | composite measures of improvement in disease state | ≥ 3 month from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| To analyse the influence of PDQ score on the treatment response | we analyse if the painDETECT questionnaire score (PDQ) at baseline can influence on treatment outcome | ≥ 3 month from baseline |
| Characterisation of the extra-articular manifestations in SpA patients |
Inclusion Criteria:
Exclusion Criteria:
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≥ 18 years and diagnosed with any disease of the SpA spectrum, and about to initiate or switch biological treatment. We use the Assessment of Spondyloarthritis International Society (ASAS) criteria for SpA, and the Modified New York criteria for ankylosing spondylitis
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| Name | Affiliation | Role |
|---|---|---|
| Inger Marie J Hansen, MD, DmSci | Svendborg Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital, Svendborg Hospital | Svendborg | 5700 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28698330 | Derived | Andreasen RA, Kristensen LE, Ellingsen T, Christensen R, Baraliakos X, Wied J, Aalykke C, Ulstrup T, Schiottz-Christensen B, Horn HC, Emamifar A, Duerlund B, Fischer L, Hansen IMJ. Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study. BMJ Open. 2017 Jul 10;7(7):e015536. doi: 10.1136/bmjopen-2016-015536. |
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| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D013167 | Spondylitis, Ankylosing |
| D013122 | Spinal Diseases |
| D013166 | Spondylitis |
| D025241 | Spondylarthritis |
| D011565 | Psoriasis |
| D014605 | Uveitis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D000089183 | Axial Spondyloarthritis |
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A Biobank will be established in connection with the routine blood samples taken at baseline (~ 90 ml). The blood samples will be handled and registered by research laboratory technicians at the laboratory department, and stored at Odense University Hospital, Denmark (in the cold store)
To characterise the extra-articular manifestations according to ASAS criteria |
| at baseline and ≥ 3 months from baseline |
| 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) | composite measures of improvement in disease state | ≥ 3 month from baseline |
| Change in the Harvey Bradshaws Activity Index (HBAI) | composite measures of improvement in disease state (Crohns disease) | ≥ 3 month from baseline |
| Change in fecal calprotectin (mg/kg) | ≥ 3 month from baseline |
| 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 |
| D000844 |
| Ankylosis |
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |