Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdelphi Real World

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has a clinical diagnosis of axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).

Participant has been prescribed advanced therapy within one month prior to enrolment in the study, to treat their axSpA or PsA.

Participant is aged 18 years or older at enrolment.

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • observational study

    Other intervention

    This is an observational study based on existing treatments prescribed prior to inclusion. No interventions are given as part of this research.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Axial spondyloarthritis (axSpA)1 intervention
Group B: Psoriatic arthritis (PsA)1 intervention

Trial outcomes

Primary outcomes

1

Number of participants that have achieved Low Disease Activity (LDA) at 12 months.

Time frame
At 12 months
2

Number of participants that have achieved Minimal Disease Activity (MDA) at 12 months.

Time frame
At 12 months
3

Change from baseline in PROM scores at 12 months.

Time frame
At 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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