NCT07166315

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2025Mar 2027

Study Start

First participant enrolled

July 7, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

1.6 years

First QC Date

September 3, 2025

Last Update Submit

September 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Axial spondyloarthritis (axSpA)

Patients diagnosed with axial spondyloarthritis (axSpA) who are initiating treatment with bimekizumab, upadacitinib, or a tumour necrosis factor-alpha inhibitor.

Other: observational study

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.

Other: observational study

Interventions

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

Axial spondyloarthritis (axSpA)Psoriatic arthritis (PsA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Participation in a clinical trial at enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal National Hospital for Rheumatic Diseases

Bath, Somerset, BA1 3NG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Observation

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

September 10, 2025

Study Start

July 7, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 10, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations