RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-05-21
Study Completion:2050-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03510442

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA.
  2. 2. Patients 16 years of age and older will be considered to have sJIA if they have previously met ILAR criteria for sJIA.
  3. 3. Family members of individuals included under items 1 and 2.
  4. 4. 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.
  5. 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).
  6. 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.
  7. 3. Family members of individuals included under items 1 and 2.
  8. 4. 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.
  1. 1. In adults, inability to provide informed consent and unavailability of a legally authorized representative to provide surrogate consent. In the case of minors, unavailability of a parent or guardian.
  2. 2. Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.
  3. 3. Unavailability, or inability to adhere with the schedule for follow-up visits.
  4. 4. Pregnancy

Contacts and Locations

Study Contact

Michelle R Millwood
CONTACT
(301) 827-1849
millwoodmr@mail.nih.gov
Michael J Ombrello, M.D.
CONTACT
(301) 435-4037
ombrellomj@mail.nih.gov

Principal Investigator

Michael J Ombrello, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

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

  • Michael J Ombrello, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-21
Study Completion Date2050-01-01

Study Record Updates

Study Start Date2018-05-21
Study Completion Date2050-01-01

Terms related to this study

Keywords Provided by Researchers

  • Inflammation
  • Fever
  • Arthritis
  • Sequencing
  • Natural History

Additional Relevant MeSH Terms

  • Still's Disease, Adult-Onset
  • Systemic Inflammation
  • Arthritis
  • Autoinflammatory Syndrome