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This observational study will target patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) who have started treatment with bimekizumab, upadacitinib, risankizumab, guselkumab, or a tumour necrosis factor-alpha inhibitor (e.g., adalimumab or etanercept) at NHS hospitals in the United Kingdom. Information from patients' medical records will be collected, and patients will complete surveys about their experiences with their treatment. The study will look at treatment effectiveness from both healthcare professionals' and patients' points of view.
Patient experience surveys will be administered prospectively throughout the study period, whereas the review of patients' medical records will be conducted retrospectively towards the end of the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axial spondyloarthritis (axSpA) | Patients diagnosed with axial spondyloarthritis (axSpA) who are initiating treatment with bimekizumab, upadacitinib, or a tumour necrosis factor-alpha inhibitor. |
| |
| Psoriatic arthritis (PsA) | Patients diagnosed with psoriatic arthritis (PsA) who are initiating treatment with bimekizumab, upadacitinib, risankizumab, guselkumab or a tumour necrosis factor-alpha inhibitor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | This is an observational study based on existing treatments prescribed prior to inclusion. No interventions are given as part of this research. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that have achieved Low Disease Activity (LDA) at 12 months. | At 12 months | |
| Number of participants that have achieved Minimal Disease Activity (MDA) at 12 months. | At 12 months | |
| Change from baseline in PROM scores at 12 months. | At 12 months |
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Inclusion Criteria:
Exclusion Criteria:
-Participation in a clinical trial at enrolment.
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Participants will be selected from patients attending NHS hospitals and related healthcare sites targeted across the United Kingdom, including England, Scotland, Wales, and Northern Ireland. These sites are secondary and tertiary care centres where patients with axial spondyloarthritis or psoriatic arthritis are routinely managed by rheumatology services.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SpA Extend Team | Contact | +441625 577 829 | arwspaextend@adelphigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal National Hospital for Rheumatic Diseases | Recruiting | Bath | Somerset | BA1 3NG | United Kingdom |
Individual participant data (IPD) from this study will not be shared with other researchers. In accordance with the study protocol and relevant data protection regulations, including GDPR, only aggregated data and summary results will be made available for scientific dissemination. All data provided will be fully anonymized and presented in aggregate form to ensure participant confidentiality and privacy. No individual-level data or information that could identify participants will be shared outside of the authorized study team.
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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