What this study is
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.
Study details
- Official title
- Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease and Related Inflammatory Conditions
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Conditions
- Still's Disease, Adult-Onset · Systemic Inflammation · Arthritis · Autoinflammatory Syndrome
- Enrolling
- 2,000 people
- Starts
- 2018-05-21
- Est. completion
- 2050-01-01
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 1 Day – 100 YearsSex ALLHealthy volunteers AcceptedAffected subject
You may qualify if
- 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.
You can't join if
- 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
Healthy Subjects
You may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contact800-411-1222 ext. TTY8664111010prpl@cc.nih.gov
Recruiting
Study team
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study ID 180081
Principal investigator
Michael J Ombrello, M.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.