This study is NOT currently recruiting participants.
Number
03-AR-0131
Sponsoring Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Children
Keywords
Arthritis; Spondylarthropathy; Spine; Hereditary; Disability; Natural History
Recruitment Keyword(s)
Ankylosing Spondylitis; Spondyloarthropathy; Spondyloarthritis; AS
Condition(s)
Ankylosing Spondylitis
Investigational Drug(s)
None
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Patients who developed ankylosing spondylitis after age 16 may be eligible for this study. The onset of disease is dated to the first appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not participate. Candidates will be screened with a medical history and physical examination, blood test, and review of their medical records. They will also complete a questionnaire about their disease symptoms and medical history.
Those enrolled in the study will return to the NIH Clinical Center at 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months after screening for examination of the joints, measurement of flexibility of the spine, and a blood test. They will also complete symptoms assessment and coping questionnaires. At the first study visit (screening visit), x-rays will be taken of the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. These x-ray studies will be repeated on all patients every two years during the study (at 24 and 48 months after screening).
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INCLUSION AND EXCLUSION CRITERIA: Participants will: 1. have been diagnosed with AS by the modified New York criteria. 2. be able to read English or Spanish Potential participants will be excluded if: 1. have a spondyloarthropathy other than AS. 2. are unable to provide informed consent. 3. anticipate not being available or able to comply with the schedule of study visits. Study entry is not limited by sex or ethnic origin. Children will necessarily be excluded because spondyloarthropathy developing before age 16 is considered a form of juvenile idiopathic arthritis, and because different age-appropriate measures of functional disability and pain would be needed. Participants will be recruited by physician referral and self-referral. Information about the study will be mailed to local rheumatologists and posted on the NIH website. Notices will also be sent to local rheumatologists and posted on the NIH website. Notices will also be sent to local chapters of the Arthritis Foundation and the Spondylitis Association of America. The accrual ceiling will be unlimited. Approximately 700 patients will be enrolled from all study sites. Approximately 150 patients will be recruited at the NIH. Other sites participating in this study are Cedars-Sinai Medical Center, Los Angeles, CA; the University of California-San Francisco and University of Texas-Houston Health Sciences Center.
Participants will:
1. have been diagnosed with AS by the modified New York criteria.
2. be able to read English or Spanish
Potential participants will be excluded if:
1. have a spondyloarthropathy other than AS.
2. are unable to provide informed consent.
3. anticipate not being available or able to comply with the schedule of study visits.
Study entry is not limited by sex or ethnic origin. Children will necessarily be excluded because spondyloarthropathy developing before age 16 is considered a form of juvenile idiopathic arthritis, and because different age-appropriate measures of functional disability and pain would be needed.
Participants will be recruited by physician referral and self-referral. Information about the study will be mailed to local rheumatologists and posted on the NIH website. Notices will also be sent to local rheumatologists and posted on the NIH website. Notices will also be sent to local chapters of the Arthritis Foundation and the Spondylitis Association of America.
The accrual ceiling will be unlimited. Approximately 700 patients will be enrolled from all study sites. Approximately 150 patients will be recruited at the NIH. Other sites participating in this study are Cedars-Sinai Medical Center, Los Angeles, CA; the University of California-San Francisco and University of Texas-Houston Health Sciences Center.
Principal Investigator
Referral Contact
For more information: