Immune-Competent Cell Manifestations in Psoriatic Arthritis Achilles Tendons (IMPAACT)
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|ClinicalTrials.gov Identifier: NCT03248284|
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : January 4, 2019
|Condition or disease||Intervention/treatment|
|Psoriatic Arthritis Enthesitis||Procedure: Tendon biopsy procedure|
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 (version 12; StataCorp LP).
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
|Actual Study Start Date :||August 21, 2017|
|Estimated Primary Completion Date :||June 21, 2021|
|Estimated Study Completion Date :||September 21, 2021|
- Procedure: Tendon biopsy procedure
Two tendon biopsy specimens will be obtained from one Achilles tendon with enthesitis.
- Presence of Immune-competent cells and inflammatory markers [ Time Frame: 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.
- Protein analyses [ Time Frame: Baseline ]Protein analyses performed on Achilles tendon tissue
- Adverse events [ Time Frame: From baseline to 3-month follow-up ]Number of adverse events during follow-up
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248284
|Contact: Maja S. Kragsnaes, MD PhDfellow||+ 45 firstname.lastname@example.org|
|Contact: Torkell J. Ellingsen, Prof MD PhDemail@example.com|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Torkell J. Ellingsen, Prof MD PhD +45 23238663 firstname.lastname@example.org|
|Contact: Maja S. Kragsnaes, MD PhDfellow email@example.com|
|Contact: Maja S. Kragsnaes|
|Principal Investigator:||Maja S Kragsnaes, MD PhDfellow||Odense University Hospital|