Immune-Competent Cell Manifestations in Psoriatic Arthritis Achilles Tendons

NCT03248284 · tracked via the Priya Life Science Denmark tracker

Sponsor

Odense University Hospital

Phase

Observational

Started

2017-08-21

Last updated

2025-12-05

Condition(s) studied

Psoriatic ArthritisEnthesitis

Investigational drug(s) / intervention(s)

Tendon biopsy procedure

Tendon biopsy procedure: Two tendon biopsy specimens will be obtained from one Achilles tendon with enthesitis.

Study summary

Tendon pathologies (enthesitis) are a characteristic component of psoriatic arthritis (PsA), and are observed in 35% to 50% of PsA patients. The Achilles tendon is one of the most commonly affected sites. This condition often causes great morbidity and loss of quality of life, and response only suboptimal to current intervention strategies. One of the main obstacles for the development of effective treatment methods is that the disease mechanisms remain poorly understood. To our knowledge, no one has yet ascertained the presence and function of immune-competent cells and inflammatory markers in tendons tissue from PsA patients suffering from Achilles enthesitis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Presence of Immune-competent cells and inflammatory markers — Baseline
CD3, CD4, CD8, CD20, CD34 (or CD31), CD56, S100 beta (CD57), CD68 (PGM1) or CD163, TNF-alfa, IL-6, IL-23 and other inflammatory markers.

Trial sites (2)

Facility	City	Region	Status
Odense University Hospital	Odense	Denmark	Recruiting
Diagnostic Center	Silkeborg	Denmark	Recruiting

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Other trials for the same condition

INSELMA - a Randomised Controlled Trial Active, not recruiting

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy Active, not recruiting

WORK-ON Vocational Rehabilitation for People With Inflammatory Arthritis Active, not recruiting

Safety and Efficacy of Capsule FMT in Treatment-naïve Patients With Newly Diagnosed Chronic Inflammatory Diseases Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03248284 on ClinicalTrials.gov ↗ ← All trials in Denmark