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Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NCT03510442

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–100 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
2000
US sites recruiting
1
Study start
May 21, 2018
Record last updated
October 22, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Still's Disease, Adult-Onset; Systemic Inflammation; Arthritis; Autoinflammatory Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:

Affected subject

  • Patients with signs and symptoms of sJIA will be classified as outlined in Diagnosis/Classification 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.
  • Patients with signs and symptoms of AOSD will be classified as outlined in Yamaguchi Criteria for diagnosing Adult-Onset Still's Disease.
  • 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.
  • Pregnant people with still's disease are allowed to enroll. Pregnant people will not be asked to submit to a skin biopsy or bone marrow aspiration.
  • The minimum age for participation in this study is between 0 and older.

Healthy Subjects

  • Healthy Volunteers related to individuals included under items 1 and 2 above will be enrolled.
  • Unrelated healthy volunteers will be enrolled for clinical, cellular, molecular, and biochemical assays, and genetic evaluation. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.
  • Healthy Volunteer should not have any history of autoimmune, autoinflammatory, rheumatic or proliferative/malignant disease or any unexplained inflammatory signs/symptoms or conditions (applies to unrelated).
  • The minimum age for participation in this study under this cohort is 2 years.

EXCLUSION CRITERIA

Affected and Healthy subjects

  • In adults, inability, or the lack of capacity to provide informed consent. In the case of minors, unavailability of a parent or guardian.
  • Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.
  • Unavailability, or inability to adhere with the schedule for follow-up visits

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · prpl@cc.nih.gov

Study contacts (from the official record)

  • Michelle R Millwood · (301) 827-1849 · millwoodmr@mail.nih.gov
  • Michael J Ombrello, M.D. · (301) 435-4037 · ombrellomj@mail.nih.gov
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Natural History, Genetics, and Pathophysiology of Systemic… (NCT03510442) | Bored Studies