This study is currently recruiting participants.
Number
11-AR-0223
Sponsoring Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 2 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Fetuses
Keywords
Sacroiliitis; Ankylosing Spondylitis; Spondyloarthritis; HLA-B27; Enthesitis-Related Arthritis; Natural History
Recruitment Keyword(s)
None
Condition(s)
Arthritis; Spondylitis, Ankylosing
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Arthritis and Musculoskeletal and Skin Diseases
- 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.
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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. 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. Pregnant women will be excluded from enrolling. 5. 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 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. Pregnant women are excluded from enrolling. 4. 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.
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.
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. Pregnant women will be excluded from enrolling.
5. 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 enrolled on the above protocols are also eligible.
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. Pregnant women are excluded from enrolling.
4. 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.
Principal Investigator
Referral Contact
For more information: