NIH Clinical Research Studies

Protocol Number: 03-AR-0131

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Title:
Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study
Number:
03-AR-0131
Summary:
This study will explore how genes may influence the severity of ankylosing spondylitis, a form of arthritis that affects the spine. Patients have inflammation of the joints of the spine, which may cause the bones of the spine to fuse, resulting in difficulty performing daily activities.

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).

Sponsoring Institute:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Participants will:

1. have been diagnosed with AS by the modified New York criteria.

2. be able to read English.

EXCLUSION CRITERIA:

Potential participants will be excluded if:

1. onset of AS was at age 16 or younger.

2. have a spondyloarthropathy other than AS.

3. are unable to provide informed consent.

4. 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.

Special Instructions:
Currently Not Provided
Keywords:
Arthritis
Spondylarthropathy
Spine
Hereditary
Disability
Recruitment Keyword(s):
Ankylosing Spondylitis
Spondyloarthropathy
Spondyloarthritis
AS
Condition(s):
Ankylosing Spondylitis
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Arthritis and Musculoskeletal and Skin Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Boyer GS, et al., A comparison of patients with spondyloarthropathy seen in specialty clinics with those identified in a communitywide epidemiologic study. Has the classic case misled us? Arch Intern Med. 1997 Oct 13;157(18):2111-7

Mau W, et al. ,Clinical features and prognosis of patients with possible ankylosing spondylitis. Results of a 10-year followup. J Rheumatol. 1988 Jul;15(7):1109-14.

Amor B, et al. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol. 1994 Oct;21(10):1883-7

Active Accrual, Protocols Recruiting New Patients

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