Ultrasound Enthesitis Response in Psoriatic Arthritis

Sponsor
Belfast Health and Social Care Trust
Study ID
NCT03955861
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab — BIOLOGICAL
    Subcutaneous injection
  • Certolizumab — BIOLOGICAL
    Subcutaneous injection
  • Etanercept — BIOLOGICAL
    Subcutaneous injection
  • Golimumab — BIOLOGICAL
    Subcutaneous injection
  • Secukinumab — BIOLOGICAL
    Subcutaneous injection

Study Details

The aim of this observational study will be to recruit 100 Psoriatic Arthritis (PsA) patients beginning on their biologic therapy and asses, both clinically and with the use of ultrasound (US), how enthesitis responds to biologic treatment. The decision to start treatment with a biologic therapy will be made by the patients' usual clinical rheumatology team, as part of their standard clinical care. This is independent of the study. Patients in whom treatment with these drugs for their PsA has been recommended will then be invited to participate in this study.They will then be commenced on biologic therapy at doses in line with the Summary of Product characteristics (SPC) for the product and followed up in the hospital outpatient clinic. Patients will have a full history taken and clinical exam performed prior to commencing on their prescribed biologic. The patient's history, Health Assessment Questionnaire scores and biobanking samples will be taken by the co-investigator. They will also calculate the patients tender and swollen joint score, dactylitis score, skin score, nail score and clinical enthesitis score.They will then have their tender entheseal points scanned as well as those as per the MASEI (Madrid Sonographic Enthesitis Index ) protocol by a single rheumatologist. The rheumatologist will be trained in ultrasound and will perform the scans blinded to this information both at initial consultation and at subsequent reviews. The patient will then commence their biologic treatment as planned at a separate review as per usual practise with their clinical team. Follow-up and final assessment at 4 months (±2 weeks) after starting biologic will include the clinical and ultrasound assessments as per the initial review and outlined in the schedule of assessments. They will also have a final blood sample taken at this point.

Key Dates

Start date
Feb 14, 2019
Status verified
Feb 2022
Primary completion
Jul 17, 2021
Completion
Jul 17, 2021

Study Design

Enrollment
80 participants (actual)

Primary Outcome Measure

The change in Madrid enthesitis ultrasound index (MASEI) score [ Time Frame: 4 months ]

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