Axial Spondylarthritis (axSpA)NCT07166315
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
An observational study of Axial Spondylarthritis (axSpA) and Psoriatic Arthritis (PsA), run by Adelphi Real World at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
- What is being tested?
- observational study
- How many people
- 700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jul 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -Participation in a clinical trial at enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Hospital for Rheumatic Diseases
Bath, Somerset, BA1 3NG
Clare Davey, 01225821800, clare.davey1@nhs.net
Dr William Tillett
About this study
Official title: Clinical Characteristics, Treatment Patterns and Outcomes in Patients With axSpA and PsA Following Initiation of Bimekizumab, Risankizumab, Guselkumab, Upadacitinib or a TNF Inhibitor
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.
Read the detailed description
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.
- Being tested
- observational study
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
This is an observational study based on existing treatments prescribed prior to inclusion. No interventions are given as part of this research.
| Study group | Role | What they receive |
|---|---|---|
| Axial spondyloarthritis (axSpA) | Patients diagnosed with axial spondyloarthritis (axSpA) who are initiating treatment with bimekizumab, upadacitinib, or a tumour necrosis factor-alpha inhibitor. Receives: 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. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have achieved Low Disease Activity (LDA) at 12 months.
Measured: At 12 months
Number of participants that have achieved Minimal Disease Activity (MDA) at 12 months.
Measured: At 12 months
Change from baseline in PROM scores at 12 months.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start7 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Axial Spondylarthritis (axSpA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adelphi Real World
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166315
- Sponsor's protocol ID
- AG9827
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Treatment Patterns and Outcomes in Patients With axSpA and PsA Following Initiation of Bimekizumab, Risankizumab, Guselkumab, Upadacitinib or a TNF Inhibitor
- ClinicalTrials.gov ID
- NCT07166315
- Acronym / sponsor ID
- AG9827
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Adelphi Real WorldIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axial spondyloarthritis (axSpA) | – | Other: observational studyPatients diagnosed with axial spondyloarthritis (axSpA) who are initiating treatment with bimekizumab, upadacitinib, or a tumour necrosis factor-alpha inhibitor. |
| Psoriatic arthritis (PsA) | – | Other: observational studyPatients diagnosed with psoriatic arthritis (PsA) who are initiating treatment with bimekizumab, upadacitinib, risankizumab, guselkumab or a tumour necrosis factor-alpha inhibitor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -Participation in a clinical trial at enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyThis is an observational study based on existing treatments prescribed prior to inclusion. No interventions are given as part of this research. | Other | Axial spondyloarthritis (axSpA), Psoriatic arthritis (PsA) |
Primary outcome
Number of participants that have achieved Low Disease Activity (LDA) at 12 months.
Time frame: At 12 months
Number of participants that have achieved Minimal Disease Activity (MDA) at 12 months.
Time frame: At 12 months
Change from baseline in PROM scores at 12 months.
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Spondylarthritis (axSpA) and Psoriatic Arthritis (PsA), run by Adelphi Real World at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SpA Extend Team (+441625 577 829, arwspaextend@adelphigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that have achieved Low Disease Activity (LDA) at 12 months. (time frame: At 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.