Juvenile Idiopathic ArthritisNCT06007456
Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis
An observational study of Juvenile Idiopathic Arthritis, run by IRCCS Burlo Garofolo at 2 sites in Italy.
Trial summary
Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Jan 2022to 15 Mar 2026
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Subjects with JIA during the transition to adult care
Who may be able to join
- Subjects under the age of 18 years
- Arthritis persisting for at least 6 weeks with no known cause
Who cannot join
- No consent from the patients' guardians
- Patients with Systemic onset Juvenile Idiopathic Arthritis
- Patients who developed arthritis on a pre-existing inflammatory disorder such as Inflammatory Bowel Disease, and had received previous treatments
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Burlo Garofolo
Trieste, 34137
Serena Pastore, MD, +390403785477, serena.pastore@burlo.trieste.it
- Recruiting
(Department of Medical and Biological Sciences, Rheumatology Clinic, University of Udine
Udine
Alen Zabotti, alen.zabotti@asufc.sanita.fvg.it
About this study
Official title: Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis and Outcomes Evaluation During Transition to Adult Care
Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis.
In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA, classification, transition of care
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients at onset of juvenile arthritis | New diagnosis of JIA | |
| Patients with juvenile arthritis in follow up | Subjects with JIA already followed at Rheumatologic Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care
The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).
Measured: Between 14-17 years of age
To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care
The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.
Measured: Between 14-17 years of age
To assess joint damage by radiological examination during the transition to adult care
Radiographs will be performed to assess the presence of joint damage
Measured: Between 14-17 years of age
Secondary outcomes (1)
To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care
Pain will be evaluated through the widespread pain index (WPI) scale that assesses the presence of pain in 19 designated body locations over the past 7 days. Each location is equal to a score of 1. The WPI indicates the total number of areas that are painful, giving a maximum value of 19. WPI score can range from 0 to 19.
Measured: Between 14-17 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start10 Jan 2022
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Mar 2026 (estimated)
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serena Pastore, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007456
- Sponsor's protocol ID
- RC 23/22
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2023
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis and Outcomes Evaluation During Transition to Adult Care
- ClinicalTrials.gov ID
- NCT06007456
- Acronym / sponsor ID
- RC 23/22
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- JIA, classification, transition of care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 23 Aug 2023 (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), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis.
In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients at onset of juvenile arthritis | – | –New diagnosis of JIA |
| Patients with juvenile arthritis in follow up | – | –Subjects with JIA already followed at Rheumatologic Service |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Subjects with JIA during the transition to adult care
Key inclusion criteria (2 listed)
- Subjects under the age of 18 years
- Arthritis persisting for at least 6 weeks with no known cause
Key exclusion criteria (3 listed)
- No consent from the patients' guardians
- Patients with Systemic onset Juvenile Idiopathic Arthritis
- Patients who developed arthritis on a pre-existing inflammatory disorder such as Inflammatory Bowel Disease, and had received previous treatments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care
Time frame: Between 14-17 years of age
The Juvenile Arthritis Disease score (JADAS) includes 4 measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) (0=no activity-10=maximum activity); parent global assessment of well-being, measured on a 0-10 VAS (0=very well-10=very poor); the erythrocyte sedimentation rate, normalized to a 0 to 10 scale; and a count of joints with active disease. The final score is calculated as the sum of the scores of these four components (higher scores indicate higher disease activity).
To evaluate disease activity by the Health Assessment Questionnaire - Disability Index during the transition to adult care
Time frame: Between 14-17 years of age
The Health Assessment Questionnaire - Disability Index (HAQ-DI) includes 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities, with 2 or 3 questions for each section. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8.
To assess joint damage by radiological examination during the transition to adult care
Time frame: Between 14-17 years of age
Radiographs will be performed to assess the presence of joint damage
1 secondary outcome
To evaluate non-inflammatory pain by the widespread pain index scale during transition to adult care
Time frame: Between 14-17 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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.
Serena Pastore, MD study director
IRCCS materno infantile Burlo Garofolo
2 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 Idiopathic Arthritis, run by IRCCS Burlo Garofolo at 2 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 2 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Serena Pastore, MD (+390403785477, 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?
To evaluate disease activity by the Juvenile Arthritis Disease score during the transition to adult care (time frame: Between 14-17 years of age). The study lists 3 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 14 Jun 2024.