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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 100
Healthy Volunteers: t
View:

⁃ Subjects with known or suspected sJIA, AOSD or a similar inflammatory phenotype will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center. To be eligible for follow-up visits patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects determined to not have known or suspected sJIA or AOSD, or a related

⁃ inflammatory phenotype, will not be followed.

⁃ Patients with signs and symptoms of sJIA will be classified as outlined in #1, #2 and #3 below:

• 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 with signs and symptoms of AOSD will be classified as outlined in #1, #2 and #3 below:

• 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.

• 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 with suspected sJIA, AOSD or a related inflammatory condition, as indicated by the presence of episodic fever and/or arthritis, may also be included.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Michelle R Millwood
millwoodmr@mail.nih.gov
(301) 827-1849
Backup
Michael J Ombrello, M.D.
ombrellomj@mail.nih.gov
(301) 435-4037
Time Frame
Start Date: 2018-05-21
Estimated Completion Date: 2050-01-01
Participants
Target number of participants: 2000
Treatments
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
Sponsors
Leads: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

This content was sourced from clinicaltrials.gov