Immune cells and inflammation in Achilles tendon enthesitis of psoriatic arthritis
Official title: Stereological Quantification of Immune-Competent Cells in Biopsies From Painful Achilles Tendons of Psoriatic Arthritis Patients With Ultrasonic Verified Enthesitis: An Exploratory Prospective Cohort Study
Run by Odense University Hospital · NCT03248284 · Data updated 2026-11-12
This research will look at immune cells and inflammatory markers in Achilles tendon tissue from people with psoriatic arthritis and enthesitis to see if specific cell types relate to pain, imaging, or short-term remission.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 2 sites (Odense and 1 other locations) |
| Status | Recruiting |
| Started | August 21, 2017 |
| Main results expected | December 31, 2026 |
| Study ends | March 31, 2027 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT03248284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who meet CASPAR criteria for psoriatic arthritis with insertional Achilles tendon pain and ultrasound evidence of enthesitis, and who are willing to undergo a tendon biopsy, are ideal candidates.
✕Probably not a fit
Patients without psoriatic arthritis or ultrasound-confirmed Achilles enthesitis, those with complete tendon rupture, or those unwilling or medically unsuitable for tendon biopsy are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The IMPAACT project prospectively enrolls 30 patients with psoriatic arthritis who have insertional Achilles tendon pain and ultrasound-confirmed enthesitis. Tendon biopsies from the mid-portion and the entheseal insertion will be analyzed using immunohistochemistry and a stereological technique to characterize and quantify immune-competent cells. Results will be compared with healthy Achilles tendon specimens and with specimens from patients who have chronic non-PsA Achilles tendinopathy. The study will also explore associations between tendon immune cell profiles and three-month pain remission, ultrasound findings, PsA disease activity, tendon protein analyses, cardiovascular risk factors, blood inflammation markers, and fecal microbiota composition.
Why it matters
Potential benefit: If successful, the findings could identify immune cell targets or biomarkers that help guide more effective, targeted treatments for Achilles enthesitis in people with psoriatic arthritis.
How similar studies have gone: Direct histological analysis of PsA Achilles entheses is largely novel, although related immunohistochemical methods have informed inflammation in other PsA-affected tissues.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Fulfilling the CASPAR criteria * Insertional Achilles tendon pain * Ultrasonic findings of inflammatory disease at the painful Achilles tendon insertion (= enthesitis) defined as abnormally hypoechoic (loss of normal fibrillar architecture) and/or thickened tendon at its bony attachment, seen in two perpendicular planes that may exhibit a Doppler signal or bony changes, including enthesophytes, and erosions. Exclusion Criteria: * Other inflammatory rheumatic diseases than PsA * Ultrasonic signs of complete rupture of the Achilles tendon * Not wishing to participate or not suited for project evaluation
Where it's running
-
Odense University Hospital
Odense, Denmark Recruiting -
Diagnostic Center
Silkeborg, Denmark Recruiting
Study contacts
- Principal investigator: Maja S Kragsnaes, MD PhDfellow — Odense University Hospital
- Study coordinator: Maja S. Kragsnaes, MD PhDfellow
- Email: maja.kragsnaes@dadlnet.dk
- Phone: + 45 23238663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.