Health TrialsbyHealthPanel

Immune-Competent Cell Manifestations in Psoriatic Arthritis Achilles Tendons

ConditionsPsoriatic ArthritisEnthesitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorOdense University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Psoriatic arthritis patients with Achilles enthesitis. There will be no restrictions regarding previous or current local and/or systemic anti-inflammatory treatments, however, any type of such treatment will be registered and used to stratify patients into treatment groups for the statistical analysis. Patients who have never received any systemic and/or local anti-inflammatory treatment will be referred to as treatment naïve.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Tendon biopsy procedure

    Procedure/Surgery

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Presence of Immune-competent cells and inflammatory markers

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.

Time frame
Baseline

Secondary outcomes

1

Protein analyses

Protein analyses performed on Achilles tendon tissue

Time frame
Baseline
2

Adverse events

Number of adverse events during follow-up

Time frame
From baseline to 3-month follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

University of Southern Denmark

Collaborator

Odense Patient Data Explorative Network

Collaborator

The Danish Rheumatism Association

Collaborator

The Psoriasis Association, Denmark

Collaborator

Source ClinicalTrials.gov
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