Enhanced Clinics for Patients Diagnosed With Ankylosing Spondylitis and Psoriatic Arthritis

Study Purpose

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. The time from referral for biologic therapy to initiation of treatment with a biological therapy due to the dedicated nurse to see patients. 2. 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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

· Unable to comply with study procedures

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04341233
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NHS Lothian
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Neil McKay, Dr
Principal Investigator Affiliation NHS Lothian
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Spondylitis, Ankylosing, Psoriatic Arthritis
Study Website: View Trial Website

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Neil McKay, Dr

[email protected]

01315371000

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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