Biomarkers in Pediatric Inflammatory Rheumatic Diseases (BIRPED)

January 12, 2026 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • Barcelona, Catalonia, Spain, 08025
        • Santa Creu i Sant Pau Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Months 3, 6, 9 and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Months 3, 6, 9 and 12
Correlation biomarkers
Time Frame: 1 year
Describe the correlation of Serum calportectin and Serum Amyloid Protein with the C-Reactive Protein, the Globular
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Berta Magallares, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-BIR-2017-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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