Natural History and Development of Spondyloarthritis

Recruiting now

Conditions studied: Arthritis, Spondylitis, Ankylosing

In brief

Background: \- Spondyloarthritis (SpA) is a group of bone and joint disorders that may cause back and joint pain and stiffness. In some cases, SpA can lead to abnormal bone growth affecting the joints and spine. Some patients have SpA without ever developing these growths, while others develop them after only a few years. Researchers are interested in studying people with SpA and their relatives to determine which people are more likely to develop more severe conditions. Objectives: \- To identify symptoms and medical tests that can help determine whether a person with SpA is at risk for developing more severe forms of the disease. Eligibility: * Individuals of any age who have been diagnosed with SpA. * Healthy volunteer relatives (at least 6 years of age) of the individuals with SpA. Design: * Participants will be screened with medical records and family medical histories, and will be invited to the clinical center for the study. * Participants with SpA will have a physical exam and medical history, including a study of joint movement, blood and urine tests, and questionnaires about pain and quality of life. * Participants with SpA will have imaging studies, including magnetic resonance imaging (MRI). Other samples such as skin tissue and bone marrow may also be collected for study. * Healthy volunteers will provide a blood sample and cheek cell samples. * No treatment will be provided, although treatment options will be discussed.

Key facts

Study ID: NCT01422694
Run by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
People needed: 2000
Starts: 2011-08-12
Last updated by the study team: 2026-08-03

Who can join

Age: 2 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.
Subjects with definite SpA enrolled on 11-AR-0223 are eligible for the Fecal Microbiota sub-study.
Healthy volunteers and pregnant people enrolled on the above protocols are also eligible.
EXCLUSION CRITERIA:
Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian.
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.
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.

You may not qualify if…

In the case of minors, unavailability of a parent or guardian to provide informed consent.
Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.
Unavailability, or inability to comply with the schedule for follow-up visits.
Children under the age of 2 years old.
The vast majority of minors with SpA or suspected SpA will be 6 years of age or older. However, it is possible that children younger than age 6 will be evaluated. If children under age 6 are referred for evaluation, we will ensure that they do not have any acute or chronic comorbidity that would preclude them from being safely evaluated at the NIH Clinical Center. Such patients would be referred to other appropriate pediatric hospitals.
Based on estimates of the incidence and prevalence of SpA in the pediatric and adult populations we set the accrual ceiling up to 2000. We hope to enroll up to 100 patients per year.
Fecal Microbiota Study
INCLUSION CRITERIA:
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.
Subjects with definite SpA enrolled on 11-AR-0223 are eligible for the Fecal Microbiota sub-study.
Healthy volunteers and pregnant people enrolled on the above protocols are also eligible.
EXCLUSION CRITERIA:
Inability to provide informed consent or, in the case of minors, unavailability of a parent or guardian.
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.
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.

Where it is running

National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.