Recruiting

sJIA & AOSD

Sponsor:

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

Code:

NCT03510442

Conditions

Still's Disease, Adult-Onset

Systemic Inflammation

Arthritis

Autoinflammatory Syndrome

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Still's Disease, Adult-Onset

Systemic Inflammation

Arthritis

Autoinflammatory Syndrome

Study ID

NCT03510442

Start date

May 21, 2018

Status verified date

Oct 19, 2026

Completion date

Jan 1, 2050

Anticipated

Primary completion date

Jan 1, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

Affected subject:

  • Patients with signs and symptoms of sJIA will be classified as outlined in Diagnosis/Classification Criteria.

1. Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA.
2. 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.

1. 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).
2. 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.
3. 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:

1. Healthy Volunteers related to individuals included under items 1 and 2 above will be enrolled.
2. 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.
3. 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:

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

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

adult-onset Still's disease (AOSD)

Composed of patients with known or suspected AOSD as defined by Yamaguchi criteria.

family members

Composed of family members of patients with systemic juvenile idiopathic arthritis, adult-onset Still's disease and related conditions.

healthy volunteers

Composed of healthy adults and children (above the age of 6 years) who volunteer to participate in this protocol.

related inflammatory conditions

Composed of patients with suspected inflammatory disease as indicated by the presence of episodic fever and/ or arthritis.

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 and Locations

Central contacts

Michelle R Millwood

(301) 827-1849millwoodmr@mail.nih.gov

Michael J Ombrello, M.D.

(301) 435-4037ombrellomj@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

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

Last update posted

Oct 22, 2026

Last verified

Oct 19, 2026

Keywords

  • Inflammation
  • Fever
  • Arthritis
  • Sequencing
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.