Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-O… (NCT03510442) | Clinical Trial Compass
RecruitingNot Applicable
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
United States2,000 participantsStarted 2018-05-21
Plain-language summary
Background:
Inflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic juvenile idiopathic arthritis (sJIA) is one of these conditions. So is adult-onset Still s disease (AOSD). Their causes are unknown. Researchers want to learn more about these conditions. This includes genetic changes and environmental factors.
Objective:
To study sJIA and AOSD in children and adults over time.
Eligibility:
People with known or suspected sJIA, AOSD, or similar inflammatory condition
Design:
Participants will be screened with a phone call.
Participants will have 1 visit. It may be outpatient or they may be admitted to the clinic. The visit may last up to 5 days. Participants will have:
* Medical history
* Physical exam
* Musculoskeletal exam
* Questions about overall health and quality of life, disease activity, functional status, and cognitive ability.
Participants may also have:
* Pictures taken of their skin, joints, or spine
* Blood, urine, and stool tests
* Scans or X-rays of joints with arthritis
* Chest X-ray
* Heart tests
* Skin biopsy. The skin will be numbed. The top layers of a small area will be scraped off.
Participants who have a joint aspiration may provide a fluid sample. The joint will be prepared, then fluid is removed by needle. A corticosteroid may be injected.
Participants who have a bone marrow biopsy may provide sample cells.
Participants may be seen by NIH specialists.
Members of the participant s family and healthy volunteers may give blood or saliva samples for genetic testing.
Participants may repeat some study tests every 6 months.
Who can participate
Age range
1 Day – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA.
. Patients 16 years of age and older will be considered to have sJIA if they have previously met ILAR criteria for sJIA.
. Family members of individuals included under items 1 and 2.
. Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.
. Patients 16 years of age and older will be considered to have AOSD if they meet the Yamaguchi criteria for AOSD (including a negative ANA and RF).
. Patients may be considered to have a diagnosis of AOSD if they met criteria for diagnosis in the past but do not still have present evidence of disease.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Genetic sequencing of patients
Timeframe: Ongoing
Trial details
NCT IDNCT03510442
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
. Family members of individuals included under items 1 and 2.
. Controls for clinical, cellular, molecular, and biochemical assays, and genetic evaluation will be enrolled. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.