Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study ID
- NCT03510442
- Status
- Recruiting
Conditions
- Arthritis
- Autoinflammatory Syndrome
- Still's Disease, Adult-Onset
- Systemic Inflammation
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Day - 100 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- May 21, 2018
- Status verified
- Apr 2026
- Primary completion
- Jan 1, 2050
- Completion
- Jan 1, 2050
Study Design
- Enrollment
- 2,000 participants (estimated)
Arms
- Arm: adult-onset Still's disease (AOSD)Composed of patients with known or suspected AOSD as defined by Yamaguchi criteria.
- Arm: family membersComposed of family members of patients with systemic juvenile idiopathic arthritis, adult-onset Still's disease and related conditions.
- Arm: healthy volunteersComposed of healthy adults and children (above the age of 6 years) who volunteer to participate in this protocol.
- Arm: related inflammatory conditionsComposed of patients with suspected inflammatory disease as indicated by the presence of episodic fever and/ or arthritis.
- Arm: systemic juvenile idiopathic arthritis (sJIA)Composed of patients with known or suspected sJIA as defined by the international league of Associations for Rheumatology (ILAR) criteria
Primary Outcome Measure
Genetic sequencing of patients [ Time Frame: Ongoing ]
Central Contacts
- Michelle R Millwood(301) 827-1849
- Michael J Ombrello, M.D.(301) 435-4037
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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