Ultrasound Enthesitis Response in Psoriatic Arthritis

Summary

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.

Conditions

• Psoriatic Arthritis
• Psoriasis
• Enthesitis

Interventions

BIOLOGICAL

adalimumab

Subcutaneous injection

BIOLOGICAL

Certolizumab

Subcutaneous injection

BIOLOGICAL

Etanercept

Subcutaneous injection

BIOLOGICAL

Golimumab

Subcutaneous injection

BIOLOGICAL

Secukinumab

Subcutaneous injection

Sponsors & Collaborators

• British Medical Association

  collaborator OTHER

• Psoriasis and Psoriatic Arthritis Alliance

  collaborator UNKNOWN

• Queen's University, Belfast

  collaborator OTHER

• Belfast Health and Social Care Trust

  lead OTHER

Principal Investigators

• Madeleine Rooney, MD · Queens University, Belfast

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-14

Primary Completion

2021-07-17

Completion

2021-07-17

FDA Drug

Yes

Countries

• United Kingdom

Study Locations