Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2011-08-12
Brief Summary
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\- 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.
Detailed Description
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The goals of this natural history protocol are to establish a cohort of pediatric and adult patients with SpA to prospectively evaluate the signs and symptoms, magnetic resonance imaging (MRI) and X-ray findings, and bone and inflammatory biomarkers associated with axial disease. We will study pathogenic mechanisms including the role of AS susceptibility genes and their variants in causing disease, and will identify patients for possible entry into future treatment studies.
Patients enrolled in this protocol will undergo a history, physical examination, imaging studies, and laboratory evaluation. When clinically indicated, patients may also be evaluated for extra-articular manifestations such as acute anterior uveitis, psoriasis or other skin problems, and inflammatory bowel disease. Peripheral blood samples will be collected from affected patients, unrelated healthy volunteers, and in some cases unaffected family members to help identify and study the genes involved in SpA and their functions. We may ask some subjects to undergo skin biopsy or bone marrow aspiration for research purposes, or to provide a stool sample for analysis of microbiota. For some patients and family members, we may ask permission to perform whole genome or exome sequencing. Fibroblasts and/or peripheral blood cells obtained from patients will be induced to become pluripotent stem cells that can be maintained indefinitely in culture and differentiated into cell types that are relevant to pathogenesis. Successful completion of these studies will allow rheumatologists to better recognize early SpA with axial involvement, particularly in children, and will improve our understanding of disease pathogenesis.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Healthy control
Healthy volunteers will be recruited to serve as controls
No interventions assigned to this group
Other Inflammatory Diseases
Subjects with Other Inflammatory Diseases
No interventions assigned to this group
Patients with Spondyloarthritis
Subjects with confirmed or probable SpA will be identified predominantly by physician referral.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Family members of individuals with known or suspected SpA. Family members will not be asked to submit to bone marrow aspiration or interruption of therapy.
* 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.
* 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.
* 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
* 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.
2 Years
99 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
Responsible Party
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Principal Investigators
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Sahar Lotfi-Emran, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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11-AR-0223
Identifier Type: -
Identifier Source: secondary_id
110223
Identifier Type: -
Identifier Source: org_study_id