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Psoriatic ArthritisIMPAACTNCT03248284

Immune-Competent Cell Manifestations in Psoriatic Arthritis Achilles Tendons

An observational study of Psoriatic Arthritis and Enthesitis, run by Odense University Hospital at 2 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Psoriatic Arthritis, Enthesitis
What is being tested?
Tendon biopsy procedure
Type of treatment
Surgery or procedure
How many people
30 participants
Where
2 sitesDenmark
Study dates
21 Aug 2017to 31 Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Adult, Older adult

Study 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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Maja S. Kragsnaes, MD PhDfellow contact

+ 45 23238663

maja.kragsnaes@dadlnet.dk

Torkell J. Ellingsen, Prof MD PhD contact

torkell.ellingsen@rsyd.dk

Denmark2 sites, 2 recruiting

  • Odense University Hospital

    Odense, 5000

    Torkell J. Ellingsen, Prof MD PhD, +45 23238663, torkell.ellingsen@rsyd.dk

    Maja S. Kragsnaes, MD PhDfellow, maja.kragsnaes@dadlnet.dk

    Recruiting

  • Diagnostic Center

    Silkeborg

    Maja S. Kragsnaes

    Recruiting

Other trials in Denmark

About this study

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

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.

Read the detailed description

Aim: The main objective of the IMPAACT study is to describe the histological findings of PsA Achilles enthesitis, and to a) Characterize and b) Quantify the immune-competent cell presence in tendon specimens obtained from the mid-portion and entheseal site of the Achilles tendon from PsA patients with enthesitis using immunohistochemistry and a stereological technique for the quantification. And secondly, to compare these observations with a) Those in healthy Achilles tendons, and b) Those in mono-symptomatic, non-PsA, chronic Achilles tendinopathy. Secondly, to examine whether one or more of the immune-competent cell types in the PsA tendons are associated with 3-months remission rate of Achilles tendon pain, or with baseline a) Ultrasonic findings of the Achilles tendon; b) PsA disease activity; c) Tendon protein analyses; d) Risk factors of cardiovascular disease; e) Blood biomarkers of systemic inflammation; and f) Fecal microbiota composition.

Methods: This study (IMPAACT) is a prospective, cohort study including 30 PsA patients (fulfilling the the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)) with pain at the Achilles tendon insertion. At baseline, all participants will be examined clinically regarding overall PsA disease activity (Psoriasis Area Severity Index (PASI skin score), the Research Consortium of Canada (SPARCC) Enthesitis score, swollen/tender joint count) and asked to fill out a questionnaire consisting of the validated Scandinavian (Danish) version of the Victorian Institute of Sport Assessment of Achilles tendons (VISA-A) in addition to a study-composed questionnaire comprising general questions regarding patient characteristics. An ultrasonic examination of the Achilles tendons will be performed before ultrasound guided Achilles tendon specimens will be obtained from the most painful Achilles tendon. Tendon samples will be evaluated immunohistochemically by quantifying the presence of macrophages (CD68-KP1+), T-lymphocytes (CD3+), B-lymphocytes (CD20+), natural killer cells (CD56+), neutrophils (granzyme-B+), mast cells and inflammatory markers using a stereological technique. Also, a protein analysis of the tendon tissue will be conducted. Venous blood will be analysed for levels of systemic inflammatory markers, as well as screened for cardiovascular risk factors including dyslipidaemia, and diabetes. After the baseline examination, all participants will be treated and monitored in accordance with the Danish national guideline recommendations for PsA patients. A 3-months follow-up examination will be performed to determine the remission status of the Achilles tendon pain. Data will be analysed using the STATA statistical package.

Conclusion: PsA is a painful and debilitating inflammatory disease. The current treatment remains suboptimal. We hope to provide new insight into the cellular mechanisms underlying PsA tendon and enthesis pathologies.

Being tested
Tendon biopsy procedure
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tendon biopsy procedureProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (2)

  1. Protein analyses

    Protein analyses performed on Achilles tendon tissue

    Measured: Baseline

  2. Adverse events

    Number of adverse events during follow-up

    Measured: From baseline to 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2017
  2. Study start21 Aug 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03248284
Sponsor's protocol ID
OUH-IMPAACT-02
Acronym
IMPAACT
Status last verified
Mar 2025
First submitted
9 Aug 2017
Last updated
5 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McGonagle DG, Helliwell P, Veale D. Enthesitis in psoriatic disease. Dermatology. 2012;225(2):100-9. doi: 10.1159/000341536. Epub 2012 Oct 27.

    PubMed 23108016

  • Terslev L, Naredo E, Iagnocco A, Balint PV, Wakefield RJ, Aegerter P, Aydin SZ, Bachta A, Hammer HB, Bruyn GA, Filippucci E, Gandjbakhch F, Mandl P, Pineda C, Schmidt WA, D'Agostino MA; Outcome Measures in Rheumatology Ultrasound Task Force. Defining enthesitis in spondyloarthritis by ultrasound: results of a Delphi process and of a reliability reading exercise. Arthritis Care Res (Hoboken). 2014 May;66(5):741-8. doi: 10.1002/acr.22191.

    PubMed 24151222

  • Khan KM, Cook JL, Bonar F, Harcourt P, Astrom M. Histopathology of common tendinopathies. Update and implications for clinical management. Sports Med. 1999 Jun;27(6):393-408. doi: 10.2165/00007256-199927060-00004.

    PubMed 10418074

  • Fredberg U, Stengaard-Pedersen K. Chronic tendinopathy tissue pathology, pain mechanisms, and etiology with a special focus on inflammation. Scand J Med Sci Sports. 2008 Feb;18(1):3-15. doi: 10.1111/j.1600-0838.2007.00746.x.

    PubMed 18294189

  • Ryan C, Korman NJ, Gelfand JM, Lim HW, Elmets CA, Feldman SR, Gottlieb AB, Koo JY, Lebwohl M, Leonardi CL, Van Voorhees AS, Bhushan R, Menter A. Research gaps in psoriasis: opportunities for future studies. J Am Acad Dermatol. 2014 Jan;70(1):146-67. doi: 10.1016/j.jaad.2013.08.042. Epub 2013 Oct 11.

    PubMed 24126079

  • Jacques P, Lambrecht S, Verheugen E, Pauwels E, Kollias G, Armaka M, Verhoye M, Van der Linden A, Achten R, Lories RJ, Elewaut D. Proof of concept: enthesitis and new bone formation in spondyloarthritis are driven by mechanical strain and stromal cells. Ann Rheum Dis. 2014 Feb;73(2):437-45. doi: 10.1136/annrheumdis-2013-203643. Epub 2013 Aug 6.

    PubMed 23921997

  • Kragsnaes MS, Fredberg U, Stribolt K, Kjaer SG, Bendix K, Ellingsen T. Stereological quantification of immune-competent cells in baseline biopsy specimens from achilles tendons: results from patients with chronic tendinopathy followed for more than 4 years. Am J Sports Med. 2014 Oct;42(10):2435-45. doi: 10.1177/0363546514542329. Epub 2014 Jul 31.

    PubMed 25081311

  • McGonagle D, Marzo-Ortega H, O'Connor P, Gibbon W, Hawkey P, Henshaw K, Emery P. Histological assessment of the early enthesitis lesion in spondyloarthropathy. Ann Rheum Dis. 2002 Jun;61(6):534-7. doi: 10.1136/ard.61.6.534.

    PubMed 12006328

Questions about this trial

What is this clinical trial studying?

An observational study of Psoriatic Arthritis and Enthesitis, run by Odense University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maja S. Kragsnaes, MD PhDfellow (+ 45 23238663, maja.kragsnaes@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Immune-competent cells and inflammatory markers (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03248284, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.

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