Juvenile Idiopathic ArthritisBIRPEDNCT07356804
Biomarkers in Pediatric Inflammatory Rheumatic Diseases
An observational study of Juvenile Idiopathic Arthritis and Flare Up, Symptom, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Juvenile Idiopathic Arthritis, Flare Up, Symptom
- What is being tested?
- Calprotectine
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 5 Sep 2018to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases
Who may be able to join
- Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Juvenile Idiopathic Arthritis, Flare Up, Symptom
- Being tested
- Calprotectine
- Keywords
- Calprotectin, Biomarkers
- Medical subject headings
- Arthritis, Juvenile, Symptom Flare Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalprotectineDiagnostic test
Determination of calprotectin and amyloid protein in the serum of patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Calprotectin in pediatric population with rheumatological inflammatory diseases
To assess the clinical usefulness ofserum Calprotectin in pediatric population with rheumatological inflammatory diseases
Measured: Months 3, 6, 9 and 12
Secondary outcomes (2)
Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseases
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.
Measured: Months 3, 6, 9 and 12
Correlation biomarkers
Describe the correlation of Serum calportectin and Serum Amyloid Protein with the C-Reactive Protein, the Globular
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start5 Sep 2018
- Primary completion30 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berta Magallares, Principal investigator, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356804
- Sponsor's protocol ID
- IIBSP-BIR-2017-97
- Acronym
- BIRPED
- Status last verified
- Nov 2018
- First submitted
- 13 Nov 2018
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Pediatric Inflammatory Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT07356804
- Acronym / sponsor ID
- BIRPED / IIBSP-BIR-2017-97
- Conditions
- Juvenile Idiopathic Arthritis, Flare Up, Symptom
- Keywords
- Calprotectin, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases
Key inclusion criteria (1 listed)
- Patients in follow-up in our Pediatric Rheumatology Unit, with the diagnoses of: Juvenile Idiopathic Arthritis, Connective Diseases or Autoinflammatory Diseases
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalprotectineDetermination of calprotectin and amyloid protein in the serum of patients | Diagnostic test | – |
Primary outcome
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
2 secondary outcomes
Serum Amyloid Protein in pediatric population with rheumatological inflammatory diseases
Time frame: Months 3, 6, 9 and 12
Correlation biomarkers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berta Magallares principal investigator
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis and Flare Up, Symptom, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Calprotectin in pediatric population with rheumatological inflammatory diseases (time frame: Months 3, 6, 9 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.