Ankylosing SpondylitisNCT00056849
Genetic Determinants of Ankylosing Spondylitis Severity
An observational study of Ankylosing Spondylitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This study will explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis to have more rapid fusion of the bones of the spine, more difficulty performing daily activities, or be more likely to need joint… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2003to 3 Jan 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will:
- have been diagnosed with AS by the modified New York criteria
- have had AS for 20 years or more. The duration of AS will be dated from the time of onset of symptoms of inflammatory low back pain or restricted spinal motion
- be able to read English.
- Potential participants will be excluded if:
- onset of AS was at age 16 or younger
Show all 16Show fewer
- have a spondyloarthropathy other than AS
- are unable to provide informed consent.
- Study of patients with AS for 20 years or more will provide a sample with a greater proportion of patients who will have developed the outcomes of interest. All participants will necessarily be age 37 or older. Study entry is not limited by sex or ethnic origin. 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.
- Potential 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.
- Study of first-degree relatives:
- Participants will be:
- Parent, sibling, or child (age 18 or older) of an enrolled subject.
- 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 recruitment ceiling will be unlimited. Approximately 500 subjects will be recruited from all study sites. The target sample for the primary analyses will be 400 eligible subjects. Approximately 150 subjects will be recruited at the NIH.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048-1804
About this study
Official title: Genetic Determinants of Ankylosing Spondylitis Severity - Cross Sectional Study
This study will explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis to have more rapid fusion of the bones of the spine, more difficulty performing daily activities, or be more likely to need joint surgery.
Patients who developed ankylosing spondylitis after age 16 and have had the disease for 20 years or more may be eligible for this study. The onset of disease is dated to the first appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not enroll.
Participants will complete a brief medical history and physical exam. They will fill out a 30-minute questionnaire that includes questions on demographics (such as age, ethnicity, marital status, etc.), medication history, work history, hip surgeries, and assessment of functional disability. Fifty milliliters (about 3-1/3 tablespoons) of blood will be drawn for gene testing, and X-rays will be taken of the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. Women of childbearing age will have a urine pregnancy test before having X-rays.
Read the detailed description
The susceptibility to ankylosing spondylitis (AS) is largely genetically determined. Recent studies suggest that the severity of AS is also influenced to a large extent by genetic factors. The goal of this study is to identify genes that influence the severity of AS. We hypothesize that genetic markers of susceptibility, including human leukocyte antigen (HLA) polymorphisms, are among the genes that also influence the severity of AS. Other genes that could potentially influence the severity of AS include those that affect the severity of joint inflammation and those that influence bone formation.
In this cross-sectional study, we will test the association of HLA markers and polymorphisms in several genes involved in the regulation of inflammation and bone formation with the severity of AS. Approximately 500 patients will be enrolled. Each patient will have had AS for at least 20 years. Measures of AS severity will be the extent of spinal fusion as measured radiographically, functional disability, time to permanent work disability, and need for total hip arthroplasty.
Identifying genetic markers that are associated with differences in the severity of AS will greatly enhance our understanding of the pathogenesis of this disease by suggesting mechanisms and pathways involved in the development of long-term damage. In a separate but related protocol, we will assess genetic markers associated with persistent active inflammation in patients with AS.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Arthritis, Spondyloarthropathy, Spine, Hereditary, Disability, Ankylosing Spondylitis, AS, Spondyloarthritis
- Medical subject headings
- Spondylitis, Ankylosing, Arthritis, Spondylarthropathies, Spondylarthritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2003 (estimated)
- Study start24 Mar 2003
- Primary completion3 Jan 2020
- Study completion3 Jan 2020
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 Ankylosing 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
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michael M Ward, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056849
- Sponsor's protocol ID
- 030130
- Other IDs
- 03-AR-0130
- Status last verified
- Jan 1920
- First submitted
- 25 Mar 2003
- Last updated
- 7 Jan 2020
- Results posted
- No
Publications
Gran JT, Skomsvoll JF. The outcome of ankylosing spondylitis: a study of 100 patients. Br J Rheumatol. 1997 Jul;36(7):766-71. doi: 10.1093/rheumatology/36.7.766.
PubMed 9255111Amor B, Santos RS, Nahal R, Listrat V, Dougados M. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol. 1994 Oct;21(10):1883-7.
PubMed 7837155Boyer GS, Templin DW, Bowler A, Lawrence RC, Everett DF, Heyse SP, Cornoni-Huntley J, Goring WP. A comparison of patients with spondyloarthropathy seen in specialty clinics with those identified in a communitywide epidemiologic study. Has the classic case misled us? Arch Intern Med. 1997 Oct 13;157(18):2111-7.
PubMed 9382668
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Determinants of Ankylosing Spondylitis Severity - Cross Sectional Study
- ClinicalTrials.gov ID
- NCT00056849
- Acronym / sponsor ID
- 030130
- Conditions
- Ankylosing Spondylitis
- Keywords
- Arthritis, Spondyloarthropathy, Spine, Hereditary, Disability, Ankylosing Spondylitis, AS, Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 24 Mar 2003 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 25 Mar 2003 (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.
This study will explore how genes-units of heredity-may influence the severity of ankylosing spondylitis. It will examine whether some genes may cause people with ankylosing spondylitis to have more rapid fusion of the bones of the spine, more difficulty performing daily activities, or be more likely to need joint surgery.
Patients who developed ankylosing spondylitis after age 16 and have had the disease for 20 years or more may be eligible for this study. The onset of disease is dated to the first appearance of symptoms of inflammatory low back pain or restricted spinal motion. Patients with a spondyloarthropathy other than AS may not enroll.
Participants will complete a brief medical history and physical exam. They will fill out a 30-minute questionnaire that includes questions on demographics (such as age, ethnicity, marital status, etc.), medication history, work history, hip surgeries, and assessment of functional disability. Fifty milliliters (about 3-1/3 tablespoons) of blood will be drawn for gene testing, and X-rays will be taken of the pelvis, lower back, and neck, if recent X-rays (within 1 year) are not available. Women of childbearing age will have a urine pregnancy test before having X-rays.
Detailed description
The susceptibility to ankylosing spondylitis (AS) is largely genetically determined. Recent studies suggest that the severity of AS is also influenced to a large extent by genetic factors. The goal of this study is to identify genes that influence the severity of AS. We hypothesize that genetic markers of susceptibility, including human leukocyte antigen (HLA) polymorphisms, are among the genes that also influence the severity of AS. Other genes that could potentially influence the severity of AS include those that affect the severity of joint inflammation and those that influence bone formation.
In this cross-sectional study, we will test the association of HLA markers and polymorphisms in several genes involved in the regulation of inflammation and bone formation with the severity of AS. Approximately 500 patients will be enrolled. Each patient will have had AS for at least 20 years. Measures of AS severity will be the extent of spinal fusion as measured radiographically, functional disability, time to permanent work disability, and need for total hip arthroplasty.
Identifying genetic markers that are associated with differences in the severity of AS will greatly enhance our understanding of the pathogenesis of this disease by suggesting mechanisms and pathways involved in the development of long-term damage. In a separate but related protocol, we will assess genetic markers associated with persistent active inflammation in patients with AS.
Study design
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- have been diagnosed with AS by the modified New York criteria
- have had AS for 20 years or more. The duration of AS will be dated from the time of onset of symptoms of inflammatory low back pain or restricted spinal motion
- be able to read English.
- onset of AS was at age 16 or younger
- have a spondyloarthropathy other than AS
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 7 Jan 2020.
- Background: PubMed 9255111Gran JT, Skomsvoll JF. The outcome of ankylosing spondylitis: a study of 100 patients. Br J Rheumatol. 1997 Jul;36(7):766-71. doi: 10.1093/rheumatology/36.7.766.
- Background: PubMed 7837155Amor B, Santos RS, Nahal R, Listrat V, Dougados M. Predictive factors for the longterm outcome of spondyloarthropathies. J Rheumatol. 1994 Oct;21(10):1883-7.
- Background: PubMed 9382668Boyer GS, Templin DW, Bowler A, Lawrence RC, Everett DF, Heyse SP, Cornoni-Huntley J, Goring WP. A comparison of patients with spondyloarthropathy seen in specialty clinics with those identified in a communitywide epidemiologic study. Has the classic case misled us? Arch Intern Med. 1997 Oct 13;157(18):2111-7.
- NIH Clinical Center Detailed Web PageLink 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.
Michael M Ward, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site 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 16 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 NCT00056849, 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 7 Jan 2020.