Protocol Details
Studies on the Natural History and Pathogenesis of Spondyloarthritis
This study is currently recruiting participants.
Summary
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: 99 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
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) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Arthritis and Musculoskeletal and Skin Diseases |
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
INCLUSION CRITERIA
To be eligible for follow-up visits, patients must meet the Inclusion Criteria, but not the Exclusion Criteria. Subjects will provide informed consent and then be evaluated either in the outpatient or inpatient unit of the NIH Clinical Center.
-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.
-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
-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, 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.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT01422694