Ultrasound Enthesitis Response in Psoriatic Arthritis
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|ClinicalTrials.gov Identifier: NCT03955861|
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
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.
|Condition or disease||Intervention/treatment|
|Psoriatic Arthritis Psoriasis Enthesitis||Biological: adalimumab Biological: Certolizumab Biological: Etanercept Biological: Golimumab Biological: Secukinumab|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||An Observational Study Evaluating the Utility of Ultrasound Confirmed Enthesitis as a Prognostic Marker for Response to Biologic Therapy in Psoriatic Arthritis|
|Actual Study Start Date :||February 14, 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2020|
- Biological: adalimumab
Subcutaneous injectionOther Name: Humira
- Biological: Certolizumab
Subcutaneous injectionOther Name: Cimzia
- Biological: Etanercept
Subcutaneous injectionOther Name: Enbrel
- Biological: Golimumab
Subcutaneous injectionOther Name: Simponi
- Biological: Secukinumab
Subcutaneous injectionOther Name: Cosentyx
- The change in Madrid enthesitis ultrasound index (MASEI) score [ Time Frame: 4 months ]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.
- The change in Minimal Disease Activity (MDA) response from baseline assessment [ Time Frame: 4 months ]
Composite clinical score for Psoriatic Arthritis. To be classified as MDA you need to achieve a score of at least 5/7 in the following parameters.
- Swollen Joint count of ≤ 1 of 66
- Tender joint score of ≤ 1 out of 68
- Either a PASI (Psoriasis Area Severity Index) skin score ≤ 15 or a Body Surface Score (BSA) of ≤ 3%
- Patient Pain Visual Analogue Score (VAS) of ≤ 15
- Patient Global Disease Activity VAS of ≤ 20
- HAQ ≤ 0.5
- Tender Entheseal score of ≤1out of 6 as per the Leeds Enthesitis score
- The change in Leeds Enthesitis Index (LEI) score from baseline assessment [ Time Frame: 4 months ]
Enthesitis clinical score that gives a score out of 6 based on clinical exam of entheseal sites at
- Both Lateral Epicondyle of the Humerus
- Both Medial Condyle of the Femur
- Both Achilles insertion
- The change in Dactylitis score from baseline assessment [ Time Frame: 4 months ]Dactylitis is the uniform swelling of a whole digit such that the joints cannot be identified. Tenderness when examining dactylitis should be recorded. One dactylitic digit = one swollen joint and score is out of 20 for all five digits.
- The change in 66/68 tender and swollen joint counts from baseline assessment [ Time Frame: 4 months ]Validated tool to assess 68 sites for tender joints and 66 sites for swollen joints above and below the waist in Psoriatic Arthritis
- The change in Psoriatic Arthritis Response Criteria (PsARC) response from baseline assessment [ Time Frame: 4 months ]
Composite disease activity score in Psoriatic Arthritis
The PsARC is defined as improvement in at least two of the following 4 criteria (one of which must be tender joint or swollen joint score) with no worsening of any criteria:
20% or more improvement in physician global assessment of disease activity 20% or more improvement in patient global assessment of disease activity 30% or more improvement in tender joint count 30% or more improvement in swollen joint count
- Assess change in Ultrasound (US) findings at nail bed [ Time Frame: 4 months ]Nail bed semi quantitative score changes looking at nail bed matrix thickness, nail plate morphology, colour doppler signal and nail bed thickness
- Relationship of baseline MASEI score to the clinical outcomes at baseline [ Time Frame: 4 months ]A regression analysis will be a carried out on the improvement in participant ultrasound enthesitis scores at 4 months with relation to clinical outcomes
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955861
|Contact: Madeline Rooney, MB Bch BAO||+447895563206||M.Rooney@qub.ac.uk|
|Contact: Alison Murphyfirstname.lastname@example.org|
|Study Director:||Madeleine Rooney, MD||Queens University, Belfast|