Juvenile Chronic ArthritisNCT06895278
Articular Damage in Patients With Juvenile Idiopathic Arthritis After Transition to Adult Care
An observational study of Juvenile Chronic Arthritis, run by IRCCS Burlo Garofolo at 3 sites in Italy.
Trial summary
Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Juvenile Chronic Arthritis
- What is being tested?
- Methotrexate and Biological Drug
- How many people
- 100 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients with Juvenile Idiopathic Arthritis who started transition process from a pediatric to an adult rheumatology center in the last 10 years will be enrolled
Who may be able to join
- Patients aged between 16 to 25 years who received a diagnosis of JIA in pediatric age according to International League of Associations for Rheumatology criteria (2001) and who have begun the process of transition to adult care.
- Young adults undergoing healthcare transition process from the the pediatric to adult rheumatology since 2016.
- Patients with radiological evidence of joint plates closure.
- X-ray images of hands, hips, and knees available
Who cannot join
- Patients cared at the adult rheumatology clinic who received a diagnosis of arthritis in the adult age.
- Patients with other orthopedic conditions or affected by other diseases leading to osteoporosis or skeletal deformities.
- Patients affected by other rheumatological conditions who underwent healthcare transition process from the the pediatric to adult rheumatology center.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
Azienda sanitaria di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia, Italia, 42122
Claudia Ferrari
IRCCS Materno Infantile "Burlo Garofolo"
Trieste, Italia, 34100
Serena Pastore, 0039-040-3785-477, serena.pastore@burlo.trieste.it
Istituto Azienda sanitaria universitaria Friuli Occidentale - Ospedale "Santa Maria della Misericordia"
Udine, Italia, 33100
Alen Zabotti
About this study
Official title: Evaluation of Articular Damage in Patients With Juvenile Idiopathic Arthritis (JIA) After Transition to Adult Care and Correlation With Disease Characteristics and Treatments.
Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. It is a heterogeneous disease, whose complexity is only partially encompassed by the actual classification criteria and it is characterized by prolonged synovial inflammation that can lead to joint destruction.
Whilst the assessment of structural joint damage is part of the routinary evaluation of disease severity and progression in patients with rheumatoid arthritis (RA), to the extent that it is considered a key end-point outcome in treatment efficacy studies, this is not the same for JIA. Some recommendations have been elaborated based on expert opinion, but only recently they have been translated into clinical practice. Such a discrepancy in approaching chronic arthritis has been for many years due to the lack of articular damage radiographic scoring system validated for pediatric age. Actually, joint space narrowing, bone erosions and demineralization, which is typical of adult articular damage, are not the same changes observed in pediatric population where early growth plate closure, epiphyseal deformity and growth asymmetries can be the major signs.
Read more
The transition process from the pediatric to the adult health care team is a critical moment in the clinical history of patients with JIA, often hampered by the absence of specific criteria for the assessment of disease activity, the lack of specific treatment recommendations for JIA adult patients, the poor adolescent-specific training for adult rheumatologists, and the lack of communication between pediatric and adult centers. Adult patients with JIA have their own specific identity and should not be inappropriately re-categorized as having RA, ankylosing spondylitis or another condition once transitioned to the adult rheumatologist.
The aim of this study is to quantify the articular damage of adult patient with JIA after closure of growth plates. This represent a sort of starting burden carried by the patients who receive transition to the adult rheumatologist care and which should be minimized in order to reduce long-term complications. Furthermore, the study aims to analyze possible correlations between the presence of articular damage, therapies taken in pediatric age, and characteristics of JIA at the onset and during the clinical course of the disease
- Conditions
- Juvenile Chronic Arthritis
- Being tested
- Methotrexate, Biological Drug
- Keywords
- Juvenile idiopathic arthritis, JIA, transition to adult, articular damage
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Prevalent use of methotrexate in pediatric age
Biological DrugDrug
Prevalent use of biological drugs in pediatric age
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate group | Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on methotrexate therapy Receives: Drug: Methotrexate | |
| Biologic therapy group | Patients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on biologic therapy Receives: Drug: Biological Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference between groups in the radiographic Sharp/Van der Heijde score
Radiological examinations of small joints (hands/wrists) will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Sharp/Van der Heijde score, evaluating joint space narrowing and erosion with a range from 0 to 4 and from 0 to 5, respectively. The total Sharp/van der Heijde score is calculated as the sum of the scores for joint space narrowing (range 0-120) and erosion (range 0-160) and ranges from 0 to 280.
Measured: At transition from pediatric to adult care, on average at the age of 18
Mean difference between groups in the radiographic Larsen score
Radiological examinations of knees and hips will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Larsen score. The grading scale ranges from 0 to 5 (0=intact bony outlines and normal joint space, 5=mutilating changes). The Larsen score ranges from 0 to 120.
Measured: At transition from pediatric to adult care, on average at the age of 18
Secondary outcomes (2)
Associations between the radiographic Sharp/Van der Heijde score and clinical characteristics
The following variables will be included in multivariate analysis: age, age at onset, gender, family history of autoimmunity; clinical features of the disease during pediatric age (i.e., number and type of involved joints, JIA category according to 2001 International League of Associations for Rheumatology classification criteria, presence of enthesitis, tenosynovitis, psoriasis and uveitis in the patients' history); laboratory data (i.e., blood count, inflammation indexes, immunoglobulin levels, predisposing HLA, antinuclear antibodies, rheumatoid factor; disease activity score (JADAS-27 score) in the period closest to the radiography execution; therapies taken during the pediatric disease course.
Measured: At transition from pediatric to adult care, on average at the age of 18
Associations between the radiographic Larsen score and clinical characteristics
The following variables will be included in multivariate analysis: age, age at onset, gender, family history of autoimmunity; clinical features of the disease during pediatric age (i.e., number and type of involved joints, JIA category according to 2001 International League of Associations for Rheumatology classification criteria, presence of enthesitis, tenosynovitis, psoriasis and uveitis in the patients' history); laboratory data (i.e., blood count, inflammation indexes, immunoglobulin levels, predisposing HLA, antinuclear antibodies, rheumatoid factor; disease activity score (JADAS-27 score) in the period closest to the radiography execution; therapies taken during the pediatric disease course.
Measured: At transition from pediatric to adult care, on average at the age of 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Chronic ArthritisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895278
- Sponsor's protocol ID
- RC 35/24
- Other IDs
- 1709
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 26 Mar 2025
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Articular Damage in Patients With Juvenile Idiopathic Arthritis (JIA) After Transition to Adult Care and Correlation With Disease Characteristics and Treatments.
- ClinicalTrials.gov ID
- NCT06895278
- Acronym / sponsor ID
- RC 35/24
- Conditions
- Juvenile Chronic Arthritis
- Keywords
- Juvenile idiopathic arthritis, JIA, transition to adult, articular damage
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
Juvenile idiopathic arthritis (JIA) is the most common childhood chronic rheumatic disease, encompassing all forms of arthritis that persist for more than 6 weeks, with onset before age 16, after exclusion of other causes of arthritis. It is a heterogeneous disease, whose complexity is only partially encompassed by the actual classification criteria and it is characterized by prolonged synovial inflammation that can lead to joint destruction.
Whilst the assessment of structural joint damage is part of the routinary evaluation of disease severity and progression in patients with rheumatoid arthritis (RA), to the extent that it is considered a key end-point outcome in treatment efficacy studies, this is not the same for JIA. Some recommendations have been elaborated based on expert opinion, but only recently they have been translated into clinical practice. Such a discrepancy in approaching chronic arthritis has been for many years due to the lack of articular damage radiographic scoring system validated for pediatric age. Actually, joint space narrowing, bone erosions and demineralization, which is typical of adult articular damage, are not the same changes observed in pediatric population where early growth plate closure, epiphyseal deformity and growth asymmetries can be the major signs.
The transition process from the pediatric to the adult health care team is a critical moment in the clinical history of patients with JIA, often hampered by the absence of specific criteria for the assessment of disease activity, the lack of specific treatment recommendations for JIA adult patients, the poor adolescent-specific training for adult rheumatologists, and the lack of communication between pediatric and adult centers. Adult patients with JIA have their own specific identity and should not be inappropriately re-categorized as having RA, ankylosing spondylitis or another condition once transitioned to the adult rheumatologist.
The aim of this study is to quantify the articular damage of adult patient with JIA after closure of growth plates. This represent a sort of starting burden carried by the patients who receive transition to the adult rheumatologist care and which should be minimized in order to reduce long-term complications. Furthermore, the study aims to analyze possible correlations between the presence of articular damage, therapies taken in pediatric age, and characteristics of JIA at the onset and during the clinical course of the disease
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate group | – | Drug: MethotrexatePatients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on methotrexate therapy |
| Biologic therapy group | – | Drug: Biological DrugPatients who underwent transition from pediatric to adult rheumatology care who spent most of their disease time on biologic therapy |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients with Juvenile Idiopathic Arthritis who started transition process from a pediatric to an adult rheumatology center in the last 10 years will be enrolled
Key inclusion criteria (4 listed)
- Patients aged between 16 to 25 years who received a diagnosis of JIA in pediatric age according to International League of Associations for Rheumatology criteria (2001) and who have begun the process of transition to adult care.
- Young adults undergoing healthcare transition process from the the pediatric to adult rheumatology since 2016.
- Patients with radiological evidence of joint plates closure.
- X-ray images of hands, hips, and knees available
Key exclusion criteria (3 listed)
- Patients cared at the adult rheumatology clinic who received a diagnosis of arthritis in the adult age.
- Patients with other orthopedic conditions or affected by other diseases leading to osteoporosis or skeletal deformities.
- Patients affected by other rheumatological conditions who underwent healthcare transition process from the the pediatric to adult rheumatology center.
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 |
|---|---|---|
| MethotrexatePrevalent use of methotrexate in pediatric age | Drug | Methotrexate group |
| Biological DrugPrevalent use of biological drugs in pediatric age | Drug | Biologic therapy group |
Primary outcome
Mean difference between groups in the radiographic Sharp/Van der Heijde score
Time frame: At transition from pediatric to adult care, on average at the age of 18
Radiological examinations of small joints (hands/wrists) will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Sharp/Van der Heijde score, evaluating joint space narrowing and erosion with a range from 0 to 4 and from 0 to 5, respectively. The total Sharp/van der Heijde score is calculated as the sum of the scores for joint space narrowing (range 0-120) and erosion (range 0-160) and ranges from 0 to 280.
Mean difference between groups in the radiographic Larsen score
Time frame: At transition from pediatric to adult care, on average at the age of 18
Radiological examinations of knees and hips will be pseudo-anonymized and centralized to a blinded radiologist to evaluate damage using the Larsen score. The grading scale ranges from 0 to 5 (0=intact bony outlines and normal joint space, 5=mutilating changes). The Larsen score ranges from 0 to 120.
2 secondary outcomes
Associations between the radiographic Sharp/Van der Heijde score and clinical characteristics
Time frame: At transition from pediatric to adult care, on average at the age of 18
Associations between the radiographic Larsen score and clinical characteristics
Time frame: At transition from pediatric to adult care, on average at the age of 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Chronic Arthritis, run by IRCCS Burlo Garofolo at 3 sites in Italy.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Serena Pastore, Pediatric rheumatologist (0039-040-3785-477, serena.pastore@burlo.trieste.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference between groups in the radiographic Sharp/Van der Heijde score (time frame: At transition from pediatric to adult care, on average at the age of 18). The study lists 2 primary outcomes in all. 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 26 Mar 2025.