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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00081562
Other study ID # NIAMS-098
Secondary ID 5R01AR046208-05N
Status Completed
Phase N/A
First received April 15, 2004
Last updated February 19, 2008
Start date September 1999
Est. completion date December 2006

Study information

Verified date February 2008
Source National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

Ankylosing spondylitis (AS) is a chronic inflammatory disease that affects the joints between the vertebrae of the spine and the joints between the spine and the pelvis. The purpose of this study is to collect information and blood samples from patients with AS and their relatives for use in genetic studies.


Description:

AS is a chronic inflammatory disease that eventually causes the affected vertebrae to fuse or grow together. The cause of AS is unknown, but genetic factors seem to play a role. Risk factors include a family history of ankylosing spondylitis and male gender.

This study will collect patient information and blood samples from affected patients (and when available, both parents of the affected patients) of 400 families with children fulfillling the modified New York criteria for AS. Diagnosis of AS will be verified by patient questionnaire, medical record review, and pelvic radiographs. Information from these patients will be used to search the human genome for disease-associated loci and/or genes. This study will also utilize contributions of investigators who have conducted recent clinical or genetic research in AS at 10 academic medical centers throughout North America (the North American Spondylitis Consortium, or NASC).


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Meet modified New York criteria for ankylosing spondylitis (AS)

- AS as confirmed by X-rays of sacroiliac joints (between the pelvis and spine)

- At least two siblings in family with AS

- Parents of the participants with AS have the option of also being enrolled

Study Design

N/A


Locations

Country Name City State
United States University of Texas - Health Science Center at Houston Houston Texas
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Brown MA, Wordsworth BP, Reveille JD. Genetics of ankylosing spondylitis. Clin Exp Rheumatol. 2002 Nov-Dec;20(6 Suppl 28):S43-9. Review. — View Citation

Reveille JD. The genetic basis of spondyloarthritis. Curr Rheumatol Rep. 2004 Apr;6(2):117-25. Review. — View Citation

Tsui FW, Tsui HW, Cheng EY, Stone M, Payne U, Reveille JD, Shulman MJ, Paterson AD, Inman RD. Novel genetic markers in the 5'-flanking region of ANKH are associated with ankylosing spondylitis. Arthritis Rheum. 2003 Mar;48(3):791-7. — View Citation

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