This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

HomeBrowseAboutFAQs
Log In
Sign Up
Ankylosing Spondylitis

Genetic Determinants of Ankylosing Spondylitis Severity

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

About this trial

Last updated 5 years ago

Study ID

030130

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18 to 100 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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.

What are the Participation Requirements?

- INCLUSION AND EXCLUSION CRITERIA:

Participants will:

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

2. 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

3. be able to read English.

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.

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:

1. Parent, sibling, or child (age 18 or older) of an enrolled subject.

2. 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.

The recruitment ceiling will be unlimited. Approximately 500 subjects will be recruited
from all study sites. The target sample for the primary analyses will be 400 eligible
subjects. Approximately 150 subjects will be recruited at the NIH.

Locations

Location

Status