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OpenTrials
Completed

NCT Number: NCT07356804

Biomarkers in Pediatric Inflammatory Rheumatic Diseases

A prospective study is proposed to serially determine new biomarkers: Calprotectin and Serum Amyloid Protein, alongside 'conventional' biomarkers: CRP and ESR, to help evaluate their utility in routine clinical practice

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Key information

About this study

Pediatric inflammatory rheumatic diseases are relatively uncommon, but they represent the largest group of chronic diseases in childhood/adolescence and the leading cause of disability among children in developed countries. Poor control of the inflammatory activity of any of the aforementioned diseases can lead to growth failure (issues with growth and maturation), alterations in quality of life and school schedule for the patients, limitations secondary to joint impairments (especially in the case of JIA), and in the long term, the development of acquired amyloidosis (AA), which is a complication of any uncontrolled inflammatory process and significantly increases the morbidity and mortality of affected patients.The prognosis of pediatric inflammatory rheumatic diseases depends on the proper control of inflammation as well as the management of the immunosuppressive drugs used for this purpose. Even today, clinicians face many uncertainties in assessing the inflammatory status of our patients. Therefore, a prospective study is proposed to serially measure new biomarkers-Calprotectin and Serum Amyloid Protein-alongside 'conventional' biomarkers-CRP and ESR-to help evaluate their utility in routine clinical practice

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases

Exclusion criteria

No

Treatment and study plan

Calprotectine

Diagnostic Test

Determination of calprotectin and amyloid protein in the serum of patients

Primary outcomes

  1. Serum Calprotectin in pediatric population with rheumatological inflammatory diseases

    Time frame: Months 3, 6, 9 and 12

    To assess the clinical usefulness ofserum Calprotectin in pediatric population with rheumatological inflammatory diseases

Secondary outcomes

  1. Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseases

    Time frame: Months 3, 6, 9 and 12

    To assess the clinical usefulness of Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseasesSedimentation Rate and the Clinical Criterion.

    Describe the evolution over time of these markers.

  2. Correlation biomarkers

    Time frame: 1 year

    Describe the correlation of Serum calportectin and Serum Amyloid Protein with the C-Reactive Protein, the Globular

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Acronym: BIRPED

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.