Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study

• Register: ClinicalTrials.gov
• Last refreshed on: 4 February 2013
• Main ID: NCT00056719
• Date of registration: 21/03/2003
• Primary sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Public title: Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study
• Scientific title: Genetic Determinants of Ankylosing Spondylitis Severity - Longitudinal Study
• Date of first enrolment: March 2003
• Target sample size: 99999999
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00056719
• Study type: Observational
• Study design: N/A

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)

• Name: Michael M Ward, M.D.

• Name: Michael M Ward, M.D.
• Affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Key inclusion & exclusion criteria

- INCLUSION AND EXCLUSION CRITERIA:

Participants will:

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

2. 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.

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
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. 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.

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. Former participants in our AS protocols will be notified of this
study by letter.

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 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. To ensure a sufficient sample of patients with active inflammation, enrollment in
the study will be monitored so that at least 80 patients will be included who have an ESR
of 40 mm/hr or higher at the screening visit or visit 1, or who have an elevated serum
C-reactive protein level at visit 1.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Secondary ID(s)

03-AR-0131

030131

Source(s) of Monetary Support

Please refer to primary and secondary sponsors