Natural History and Development of Spondyloarthritis

Launched by NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS) · Aug 23, 2011

Keywords

ClinConnect Summary

This clinical trial is focused on understanding spondyloarthritis (SpA), a type of arthritis that can cause pain and stiffness in the back and joints. Researchers want to learn more about how SpA develops in different individuals, especially those who may be at risk for more severe symptoms or changes in their bones and joints. The study will involve people diagnosed with SpA as well as their healthy family members, aiming to identify key symptoms and tests that can help predict who might experience more serious issues.

To participate, individuals must be diagnosed with SpA, while healthy relatives aged 6 and older are also welcome. Participants will undergo a variety of assessments, including physical exams, blood tests, and imaging studies like MRI scans. Although no treatment will be given during the study, information about available treatments will be discussed. It's important to note that participants will be closely monitored, but they must be able to provide consent, and certain medical conditions may exclude them from the study. This research aims to enhance understanding of SpA and potentially improve future care for those affected.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Subjects with known or suspected SpA 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 SpA will not be followed.
• Patients with signs and symptoms of SpA will be classified as outlined in #1 and #2 below:
• • 1. Patients less than 16 years of age will be considered to have SpA if they meet the ILAR criteria for ERA (without or with psoriasis or a positive family history of psoriasis), or modified NY criteria for AS.
• • 2. Patients 16 years of age or older will be considered to have SpA if they have previously met ILAR criteria for ERA, or currently meet ESSG or Amor criteria for USpA, ASAS criteria for Axial SpA, or modified NY criteria for AS.
• • 3. Family members of individuals included under items 1 and 2. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy.
• • 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 be 6 years of age or older, and not pregnant.
• • 5. Minor healthy volunteers undergoing imaging (SI and/or WB MRI) must be old enough to complete the procedure without sedation. Generally this requires that they be at least 6 years of age, so no healthy volunteers under age 6 will be enrolled.
• • 6. Pregnant people with SpA are allowed to enrolled. Pregnant people will not be asked to undergo an MRI and will not be asked to submit to skin biopsy or bone marrow aspiration.
• EXCLUSION CRITERIA:
• • 1. Inability to provide informed consent or, 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 comply with the schedule for follow-up visits.
• • 4. Children under the age of 2 years old.
• Fecal Microbiota Study Inclusion/Exclusion Criteria:
• INCLUSION CRITERIA:
• • 1. Subjects must be enrolled on another NIH natural history protocol, including either 14-AR-0200 (Studies on the Natural History, Pathogenesis and Outcome of Idiopathic Systemic Vasculitis, P. Grayson PI); 18-AR-0081 (Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still s Disease and Related Inflammatory Conditions, M. Ombrello PI), or 94-E-0165 (Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies, Lisa Rider PI), and meet the respective protocol s criteria for a diagnosis of systemic vasculitis, systemic juvenile idiopathic arthritis, or dermatomyositis.
• • 2. Subjects with definite SpA enrolled on 11-AR-0223 are eligible for the Fecal Microbiota sub-study.
• • 3. Healthy volunteers and pregnant people enrolled on the above protocols are also eligible.
• EXCLUSION CRITERIA:
• • 1. Inability to provide informed consent or, 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, expose subjects to more than minimal risk, or confuse the interpretation of the study.
• • 3. Subjects (including healthy volunteers) less than 4 years of age are excluded due to the challenging practical considerations of collecting stool samples, and because spondyloarthritis is much less common in this age group.