SpondylitisNCT00081562
Genetics of Ankylosing Spondylitis
An observational study of Spondylitis and Ankylosing Spondylitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Spondylitis, Ankylosing Spondylitis
- How many people
- 1,600 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1999to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas - Health Science Center at Houston
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Family Studies of the Genetics of Ankylosing Spondylitis
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.
Read the 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).
- Conditions
- Spondylitis, Ankylosing Spondylitis
- Medical subject headings
- Spondylitis, Spondylitis, Ankylosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2004 (estimated)
- Study startSep 1999
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,600 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- John D. Reveille, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00081562
- Sponsor's protocol ID
- NIAMS-098
- Other IDs
- 5R01AR046208-05, NASC
- Status last verified
- Feb 2008
- First submitted
- 15 Apr 2004
- Last updated
- 21 Feb 2008
- Results posted
- No
Publications
Brown MA, Wordsworth BP, Reveille JD. Genetics of ankylosing spondylitis. Clin Exp Rheumatol. 2002 Nov-Dec;20(6 Suppl 28):S43-9.
PubMed 12463446Tsui 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.
PubMed 12632434Reveille JD. The genetic basis of spondyloarthritis. Curr Rheumatol Rep. 2004 Apr;6(2):117-25. doi: 10.1007/s11926-004-0056-6.
PubMed 15016342
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Studies of the Genetics of Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00081562
- Acronym / sponsor ID
- NIAMS-098
- Conditions
- Spondylitis, Ankylosing Spondylitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Sep 1999
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 19 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2008.
- Background: PubMed 12463446Brown MA, Wordsworth BP, Reveille JD. Genetics of ankylosing spondylitis. Clin Exp Rheumatol. 2002 Nov-Dec;20(6 Suppl 28):S43-9.
- Background: PubMed 12632434Tsui 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.
- Background: PubMed 15016342Reveille JD. The genetic basis of spondyloarthritis. Curr Rheumatol Rep. 2004 Apr;6(2):117-25. doi: 10.1007/s11926-004-0056-6.
- Click here for the North American Spondylitis Consortium \[NASC\] Web site.Link provided by the sponsor.
- Click here for the Spondylitis Association of America Web site.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Reveille, MD principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylitis and Ankylosing Spondylitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00081562, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2008.