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Genetics of Ankylosing Spondylitis

Primary Purpose

Spondylitis, Ankylosing Spondylitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Spondylitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center
  • University of Texas - Health Science Center at Houston

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 15, 2004
Last Updated
February 19, 2008
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00081562
Brief Title
Genetics of Ankylosing Spondylitis
Official Title
Family Studies of the Genetics of Ankylosing Spondylitis
Study Type
Observational

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondylitis, Ankylosing Spondylitis

7. Study Design

Enrollment
1600 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Reveille, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of Texas - Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12463446
Citation
Brown MA, Wordsworth BP, Reveille JD. Genetics of ankylosing spondylitis. Clin Exp Rheumatol. 2002 Nov-Dec;20(6 Suppl 28):S43-9.
Results Reference
background
PubMed Identifier
12632434
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. doi: 10.1002/art.10844.
Results Reference
background
PubMed Identifier
15016342
Citation
Reveille JD. The genetic basis of spondyloarthritis. Curr Rheumatol Rep. 2004 Apr;6(2):117-25. doi: 10.1007/s11926-004-0056-6.
Results Reference
background
Links:
URL
http://www.asresearch.org
Description
Click here for the North American Spondylitis Consortium [NASC] Web site.
URL
http://www.spondylitis.org/
Description
Click here for the Spondylitis Association of America Web site.

Learn more about this trial

Genetics of Ankylosing Spondylitis

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