NCT03248284

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Aug 2017Mar 2027

First Submitted

Initial submission to the registry

August 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

August 21, 2017

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

December 5, 2025

Status Verified

March 1, 2025

Enrollment Period

9.4 years

First QC Date

August 9, 2017

Last Update Submit

December 1, 2025

Conditions

EnthesitisPsoriatic Arthritis

Outcome Measures

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.

    Baseline

Secondary Outcomes (2)

  • Protein analyses

    Baseline

  • Adverse events

    From baseline to 3-month follow-up

Interventions

Tendon biopsy procedurePROCEDURE

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Diagnostic Center

Silkeborg, Denmark

RECRUITING

Related Publications (8)

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

    PMID: 23108016BACKGROUND

  • 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.

    PMID: 24151222BACKGROUND

  • 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.

    PMID: 10418074BACKGROUND

  • 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.

    PMID: 18294189BACKGROUND

  • 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.

    PMID: 24126079BACKGROUND

  • 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.

    PMID: 23921997BACKGROUND

  • 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.

    PMID: 25081311BACKGROUND

  • 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.

    PMID: 12006328BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Achilles tendon tissue specimens, blood- and fecal samples

MeSH Terms

Conditions

Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maja S Kragsnaes, MD PhDfellow

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja S. Kragsnaes, MD PhDfellow

CONTACT

+ 45 23238663maja.kragsnaes@dadlnet.dk

Torkell J. Ellingsen, Prof MD PhD

CONTACT

torkell.ellingsen@rsyd.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof MD PhD

Study Record Dates

First Submitted

August 9, 2017

First Posted

August 14, 2017

Study Start

August 21, 2017

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

December 5, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)