Spondylitis, AnkylosingECAPNCT04341233
Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis
An observational study of Spondylitis, Ankylosing and Psoriatic Arthritis, run by NHS Lothian.
Trial summary
The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital. It is anticipated that this new model of care will improve: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spondylitis, Ankylosing, Psoriatic Arthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of ankylosing spondylitis or psoriatic arthritis requiring initiation of biologic therapy.
Who may be able to join
- Clinical diagnosis of AS or PsA
- Referral for initiation of biological therapy by patients regular consultant
- Age 18 years or older
- Willing and able to give informed consent
Who cannot join
- Unable to comply with study procedures
About this study
The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital.
It is anticipated that this new model of care will improve:
- The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients
- The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines
- Conditions
- Spondylitis, Ankylosing, Psoriatic Arthritis
- Keywords
- Nurse-Led Service, Enhanced Clinics
- Medical subject headings
- Spondylitis, Ankylosing, Arthritis, Psoriatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Setup a nurse-led clinic
Appointing a nurse and training in biologic and DMARD counselling, clinical measures and clinic administration.
Measured: 3 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to record data on the time taken to commence treatment with a biologic therapy from the point of initial referral to biologic therapy.
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to audit the results of the existing service for AS and PsA patients within the department (based on a cohort of 60 patients most recently initiated on biologics treatment within the department).
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to audit the results of the implementation of the clinic within the department.
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to assist with demonstrating that the care of patients within the clinic is in accordance with the NICE clinical guidelines and that there has been a reduction in the time to initiate biologic therapy at the end of the project against the baseline assessment.
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to develop a patient referral pathway into a new model of AS and PsA patient care, specifically in the nurse-led clinic.
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to utilise the new nurse-led clinic to improve consistency of care by reviewing and optimising biologic therapy for all new AS and PsA patients within the department according to NICE guideline recommendations.
Measured: 19.5 months
Develop and setup a tool, an NHS Lothian Excel database
Database enables trust to use the evaluated model of care to enable NHS Lothian to build an informed business case to fund the continuation of this service in the future and expand it to all patients in their current service.
Measured: 19.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Aug 2020 (estimated)
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Why it stopped: withdrawn pre approvals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Neil McKay, Dr, Principal investigator, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341233
- Sponsor's protocol ID
- IRAS No: 265399
- Acronym
- ECAP
- Status last verified
- Feb 2025
- First submitted
- 7 Apr 2020
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT04341233
- Acronym / sponsor ID
- ECAP / IRAS No: 265399
- Conditions
- Spondylitis, Ankylosing, Psoriatic Arthritis
- Keywords
- Nurse-Led Service, Enhanced Clinics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: withdrawn pre approvals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 10 Apr 2020 (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.
The 19.5 months project will pilot the introduction of a hospital-based, nurse-led ankylosing spondylitis (AS) and psoriatic arthritis (PsA) service for patients being initiated on biologic therapy in NHS Lothian Edinburgh Western General Hospital.
It is anticipated that this new model of care will improve:
- The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients
- The management and monitoring of AS and PsA patients post commencement of treatment , in line with The National Institute for Health and Care Excellence (NICE) guidelines
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of ankylosing spondylitis or psoriatic arthritis requiring initiation of biologic therapy.
Key inclusion criteria (4 listed)
- Clinical diagnosis of AS or PsA
- Referral for initiation of biological therapy by patients regular consultant
- Age 18 years or older
- Willing and able to give informed consent
Key exclusion criteria (1 listed)
- Unable to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Setup a nurse-led clinic
Time frame: 3 months
Appointing a nurse and training in biologic and DMARD counselling, clinical measures and clinic administration.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to record data on the time taken to commence treatment with a biologic therapy from the point of initial referral to biologic therapy.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to audit the results of the existing service for AS and PsA patients within the department (based on a cohort of 60 patients most recently initiated on biologics treatment within the department).
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to audit the results of the implementation of the clinic within the department.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to assist with demonstrating that the care of patients within the clinic is in accordance with the NICE clinical guidelines and that there has been a reduction in the time to initiate biologic therapy at the end of the project against the baseline assessment.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to develop a patient referral pathway into a new model of AS and PsA patient care, specifically in the nurse-led clinic.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to utilise the new nurse-led clinic to improve consistency of care by reviewing and optimising biologic therapy for all new AS and PsA patients within the department according to NICE guideline recommendations.
Develop and setup a tool, an NHS Lothian Excel database
Time frame: 19.5 months
Database enables trust to use the evaluated model of care to enable NHS Lothian to build an informed business case to fund the continuation of this service in the future and expand it to all patients in their current service.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- National Institute for Health and Care Excellence (2016) Spondyloarthritis in over 16s: Diagnosis and management (NICE Guideline NG65).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Neil McKay, Dr principal investigator
NHS Lothian
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylitis, Ankylosing and Psoriatic Arthritis, run by NHS Lothian.
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 4 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: withdrawn, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Setup a nurse-led clinic (time frame: 3 months). The study lists 8 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 13 Feb 2025.