Natural History and Development of Spondyloarthritis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-99
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Subjects with known or suspected SpA.
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.
Trial population
Children and adults with spondyloarthropathies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 3 trial groupsGroup A: Healthy control
Group B: Other Inflammatory Diseases
Group C: Patients with Spondyloarthritis
Trial outcomes
Primary outcomes
1
Progression from SpA to Axial Spa and to AS
sacroiliac damage on x-ray
Time frame
10 yearsSecondary outcomes
1
Measures of disease activity (BASDAI and ASDAS) and function (BASFI).
Time frame
ongoingSponsors and contacts
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Source ClinicalTrials.gov