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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 April 2014
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
Contacts
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 or Spanish

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.

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
Intervention(s)
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
03-AR-0131
030131
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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