An observational study in Juvenile Idiopathic Arthritis, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 6 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Shanghai Jiao Tong University School of Medicine · Observational
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Among 20 studies in Arthritis, Juvenile with a site in China — 10 open to participants now, 10 under way, 4 of them phase 3. Arthritis, Juvenile · China.
Among the 20 studies in Arthritis, Juvenile with a site in China, this one is the only one that started in 2026, is one of 6 observational ones, and was the 20th registered.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
Browse Arthritis, Juvenile studies →10 of the 20 studies in Arthritis, Juvenile with a site in China are open now. Recruiting first, the newest first:
Chongqing Precision Biotech Co., Ltd · Sites in China
Ages 5+
Bristol-Myers Squibb · Sites in China, United States, Brazil and 8 more countries
Ages 5–17
Janssen Research & Development, LLC · Sites in China, United States, Argentina and 15 more countries
Ages 3+
Changchun GeneScience Pharmaceutical Co., Ltd. · Sites in China
Ages 2–17
AbbVie · Sites in China, United States, Argentina and 14 more countries
Ages 1–17
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 69 Arthritis, Juvenile studies recruiting now, 13 (19%) set no upper age limit and 50 (72%) stop at 75 or younger; 65 take children under 18; 11 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 1 · Phase 3 8 · Phase 4 1
First in 2013; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 120 across 118 observational studies indexed under Arthritis, Juvenile.
Median enrollment 83 across the 14 interventional studies, 1,850 across the 6 observational. Of the 6 that completed or were terminated, 4 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 20 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
Shanghai Jiao Tong University School of Medicine has 1 study filed under Arthritis, Juvenile — fewer than ten, so there is no comparison to draw.
1 of the studies in Arthritis, Juvenile with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07799831Shanghai Jiao Tong University School of MedicineOral Health, Saliva Bacteria, and Disease Activity in Children With JIA: A Cross-Sectional Study. | 2027-07 |
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Among the 20 studies in Arthritis, Juvenile with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this observational study is to learn about the relationship between disease activity and oral health status in children with juvenile idiopathic arthritis (JIA). The main question it aims to answer is:
Is disease activity associated with oral health in children with JIA? Do children with active disease have poorer oral health compared to those in clinical remission? Participants already receiving routine rheumatology care for JIA will undergo a single study visit. At that visit, disease activity will be assessed, an oral health examination will be performed, and saliva samples will be collected. Based on the disease activity assessment, participants will be classified into two groups: those with active disease and those in remission. Oral health measures and saliva-related parameters will be compared between the two groups.
This study is expected to provide preliminary evidence to help identify JIA children at higher risk of oral health problems and to support the integration of oral health evaluation into comprehensive JIA management.
Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, characterised by alternating periods of active disease and remission. Despite therapeutic advances, joint involvement in the hands, wrists, or temporomandibular joints can hinder daily oral hygiene practices, and long-term medication use may affect the oral microenvironment, increasing the risk of dental caries and gingivitis. In current routine rheumatology follow-up in China, oral health status is not systematically assessed; it is usually addressed only when the child complains of symptoms, leading to delayed recognition and intervention.
This single-centre, cross-sectional observational study aims to compare oral health status between JIA children with different levels of disease activity and to preliminarily explore the association of salivary local biological characteristics with disease activity. No intervention is applied. All data are collected at a single time point during a regular outpatient visit.
Study Population Children aged 6 to 16 years who meet the ILAR classification criteria for JIA are eligible. Exclusion criteria include use of systemic antibiotics within the past 3 months, ongoing fixed orthodontic treatment, presence of other systemic conditions known to affect oral health (e.g., diabetes, Sjögren's syndrome), or inability to cooperate with the examination.
Grouping and Assessments At enrolment, two experienced rheumatologists independently classify each participant as having "active disease" or "clinical remission" based on standardised clinical assessment (joint examination, physician global assessment, and routine laboratory inflammatory markers). During the same visit, the following are completed: (1) collection of demographic and disease-related data; (2) a comprehensive oral clinical examination conducted by trained dentists, covering dental hard tissues, periodontal soft tissues, and oral hygiene status; and (3) collection of unstimulated whole saliva for subsequent analysis of local inflammatory markers and microbial community profiles. All data are recorded using coded identifiers to protect participant privacy.
Statistical Analysis Oral health parameters will be compared between the two groups, with multivariable methods used to control for potential confounders such as age, sex, and disease duration. The correlation between continuous disease activity scores and composite oral health indices will be evaluated. Saliva data will be explored for associations with disease activity and oral health parameters.
Clinical Significance This study addresses a long-neglected but clinically relevant question: whether disease activity in JIA is associated with oral health status. If children with active disease show poorer oral conditions, this would support the need for rheumatologists to actively inquire about oral hygiene habits and dental history during follow-up, and to consider incorporating basic oral health screening (e.g., questions on brushing, gum bleeding, toothache) into routine visits. Through this work, we aim to promote clinical awareness of oral health issues in children with chronic diseases and advocate for the inclusion of oral health assessment as a fundamental component of JIA chronic disease management, fostering collaboration between paediatric rheumatology and dentistry, and ultimately improving patients' quality of life.
Children aged 6 to 16 years diagnosed with juvenile idiopathic arthritis according to the ILAR classification criteria (excluding systemic-onset subtype), recruited from both inpatient and outpatient rheumatology services at the study site. Healthy controls aged 6 to 16 years with no history of chronic inflammatory or autoimmune diseases are recruited from the same city. All participants must be able to cooperate with oral examination and saliva collection. Written informed consent is obtained from parents or legal guardians, and assent from children.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the active disease subgroup, all of the following must be met:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 6 to 16 years diagnosed with juvenile idiopathic arthritis according to the ILAR classification criteria, receiving routine rheumatology care at the study site. Participants are classified into active disease or clinical remission subgroups based on standardised clinical assessment at enrolment. No intervention is applied.
Healthy children aged 6 to 16 years with no history of chronic inflammatory or autoimmune diseases, recruited from the same city or community as the JIA group. No intervention is applied.
Oral Health Status
A comprehensive oral health examination is conducted by trained dentists in accordance with the World Health Organization Oral Health Surveys: Basic Methods. The examination covers dental hard tissue status, periodontal soft tissue status, oral hygiene status, oral mucosal assessment, and oral health-related behaviours. For dental caries assessment, each tooth is visually and tactilely examined under standardised lighting, and indices are calculated for permanent and primary dentition as appropriate. Periodontal status is evaluated using standardised probes to assess gingival bleeding and pocket depth. Oral hygiene is assessed following WHO recommendations; prior to evaluation, a disclosing agent is applied to tooth surfaces to visualise plaque, enabling standardised scoring of debris and calculus on representative surfaces. The oral mucosa is inspected for any soft tissue abnormalities. Oral health behaviours, including toothbrushing habits, dietary practices, and dental attendance.
Time frame: At baseline, during a single routine outpatient visit immediately after written informed consent is obtained.
Salivary Microbiota
The samples are analysed for microbial composition using 16S rRNA gene sequencing, assessing microbial diversity, relative abundance of major taxa, and compositional differences between study groups. In addition, levels of soluble inflammatory proteins are measured to evaluate local inflammatory status.
Time frame: Baseline visit (fasting morning)
Disease Activity Assessment
Disease activity is assessed by experienced rheumatologists using standardised clinical evaluation at the baseline visit. The assessment includes joint examination (swollen and tender joint count), physician global assessment of disease activity on a visual analogue scale, and routine laboratory inflammatory markers (erythrocyte sedimentation rate and C-reactive protein level). Based on the combined findings, participants are classified as having active disease or being in clinical remission.
Time frame: Baseline visit
Plan to share: No — This study does not involve a clinical trial or interventional design. The data collected include sensitive oral health and biological information from children, and participant consent obtained does not cover data sharing with external researchers. Should circumstances change in the future, we will update this plan accordingly.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 months after the start.
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