Ultrasound Enthesitis Response in Psoriatic Arthritis

NCT03955861 | Completed FDA Drug

• 1 other identifier: 18046MR-SW
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The change in Madrid enthesitis ultrasound index (MASEI) score

  Ultrasound enthesitis response score. This is a validated tool for assessing enthesitis in spondyloarthropathy. It assess both chronic a active features of enthesitis at the knee, plantar fascia, achilles tendon and triceps tendon. A total score of 136 can be achieved.

  4 months

Secondary Outcomes (7)

• The change in Minimal Disease Activity (MDA) response from baseline assessment

  4 months

• The change in Leeds Enthesitis Index (LEI) score from baseline assessment

  4 months

• The change in Dactylitis score from baseline assessment

  4 months

• The change in 66/68 tender and swollen joint counts from baseline assessment

  4 months

• The change in Psoriatic Arthritis Response Criteria (PsARC) response from baseline assessment

  4 months

Interventions

adalimumab BIOLOGICAL

Subcutaneous injection

Also known as: Humira

Certolizumab BIOLOGICAL

Subcutaneous injection

Also known as: Cimzia

Etanercept BIOLOGICAL

Subcutaneous injection

Also known as: Enbrel

Golimumab BIOLOGICAL

Subcutaneous injection

Also known as: Simponi

Secukinumab BIOLOGICAL

Subcutaneous injection

Also known as: Cosentyx

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Psoriatic Arthritis patients with active disease who are naive to biologic therapy

You may qualify if:

• Patients with PsA will be included if they meet ALL of the following criteria:
• Aged ≥ 18 years
• Fulfil the Classification criteria for PSA (CASPAR)
• Have not previously had biologic disease modifying treatment for their PsA
• Are due to commence on subcutaneous TNF inhibitor or secukinumab as part of their standard clinical care, in line with SPC for the product prescribed
• Are able and willing to give informed consent and comply with the requirements of the study protocol NOTE: DMARD therapy will be permitted and used as per standard clinical practice

You may not qualify if:

• Patients will not be eligible if they meet ANY of the following criteria:
• History of or current autoimmune rheumatic disease other than PsA
• Previously received a biologic therapy for PsA
• Receiving infliximab (IV TNF inhibitor)
• Haemoglobin ≤9 g/dl
• Known HUMAN immunodeficiency Virus (HIV), hepatitis C or B infection
• Current oral steroids
• Intramuscular steroids within 6 weeks of baseline (IA steroid injection will be allowed) assessment
• Pregnancy or breast feeding
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. -

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• British Medical Association: collaborator
• Psoriasis and Psoriatic Arthritis Alliance: collaborator
• Queen's University, Belfast: collaborator

Study Sites (1)

Musgrave Park Hospital

Belfast, Antrim, BT9 7JB, United Kingdom

Location

Related Publications (1)

• Elliott A, Pendleton A, Wright G, Rooney M. The relationship between the nail and systemic enthesitis in psoriatic arthritis. Rheumatol Adv Pract. 2021 Nov 19;5(3):rkab088. doi: 10.1093/rap/rkab088. eCollection 2021.

  PMID: 34888436 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Bloods samples with whole blood/serum/plasma storage for future biomarker analysis

MeSH Terms

Conditions

Arthritis, Psoriatic; Psoriasis

Interventions

Adalimumab; Certolizumab Pegol; Etanercept; golimumab; secukinumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Immunoglobulin Fc Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Madeleine Rooney, MD

  Queens University, Belfast

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: May 20, 2019
• Study Start: February 14, 2019
• Primary Completion: July 17, 2021
• Study Completion: July 17, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)