Genetic Determinants of Ankylosing Spondylitis Severity

NCT00056849 | Completed

• 2 other identifiers: 03013003-AR-0130
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study will explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis to have more rapid fusion of the bones of the spine, more difficulty performing daily activities, or be more likely to need joint surgery. Patients who developed ankylosing spondylitis after age 16 and have had the disease for 20 years or more 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 enroll. Participants will complete a brief medical history and physical exam. They will fill out a 30-minute questionnaire that includes questions on demographics (such as age, ethnicity, marital status, etc.), medication history, work history, hip surgeries, and assessment of functional disability. Fifty milliliters (about 3-1/3 tablespoons) of blood will be drawn for gene testing, and X-rays will be taken of the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. Women of childbearing age will have a urine pregnancy test before having X-rays.

Conditions

Ankylosing Spondylitis

Keywords

Arthritis; Spondyloarthropathy; Spine; Hereditary; Disability; Ankylosing Spondylitis; AS; Spondyloarthritis

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Participants will:
• have been diagnosed with AS by the modified New York criteria
• have had AS for 20 years or more. The duration of AS will be dated from the time of onset of symptoms of inflammatory low back pain or restricted spinal motion
• be able to read English.
• Potential participants will be excluded if:
• onset of AS was at age 16 or younger
• have a spondyloarthropathy other than AS
• are unable to provide informed consent.
• Study of patients with AS for 20 years or more will provide a sample with a greater proportion of patients who will have developed the outcomes of interest. All participants will necessarily be age 37 or older. Study entry is not limited by sex or ethnic origin. English literacy is required because the functional status questionnaires used in the study have not been developed and validated in many languages other than English. In particular, the HAQ-S has been validated in only English, Dutch, and Finnish. The BASFI has been validated in English, Dutch, Finnish, Swedish, German, and French. Each of these validation studies consists of a single report. Monolingual speakers of these languages are likely to be rare in our area.
• Potential 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 chapters of the Arthritis Foundation and the Spondylitis Association of America.
• Study of first-degree relatives:
• Participants will be:
• Parent, sibling, or child (age 18 or older) of an enrolled subject.
• Able to provide informed consent.
• Family members may by asymptomatic or have signs or symptoms of AS or a condition in the spondyloarthropathy family. There is no requirement for a minimum number of members per family to be eligible for participation.

Sponsors & Collaborators

• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048-1804, United States

Location

Related Publications (3)

• Gran JT, Skomsvoll JF. The outcome of ankylosing spondylitis: a study of 100 patients. Br J Rheumatol. 1997 Jul;36(7):766-71. doi: 10.1093/rheumatology/36.7.766.

  PMID: 9255111 BACKGROUND

• Amor B, Santos RS, Nahal R, Listrat V, Dougados M. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol. 1994 Oct;21(10):1883-7.

  PMID: 7837155 BACKGROUND

• Boyer GS, Templin DW, Bowler A, Lawrence RC, Everett DF, Heyse SP, Cornoni-Huntley J, Goring WP. 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.

  PMID: 9382668 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Spondylitis, Ankylosing; Arthritis; Spondylarthropathies; Spondylarthritis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases

Study Officials

• Michael M Ward, M.D.

  National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2003
• First Posted: March 25, 2003
• Study Start: March 24, 2003
• Primary Completion: January 3, 2020
• Study Completion: January 3, 2020
• Last Updated: January 7, 2020

Record last verified: 1920-01

Locations

US (1)