Ankylosing SpondylitisNCT00085995
Progression of Spinal Fusion in Ankylosing Spondylitis
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 evaluate: 1) whether computed tomography (CT) scanning is better than regular x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with ankylosing spondylitis; and 2) if CT can be used to determine how fast extra bone forms in the spine of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2004to 13 Feb 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinical sample
Who may be able to join
- Age 18 years or older
- Diagnosis of AS by the modified New York criteria
- Lumbar spine BASRI score of 0, 1, 2, or 3
- We will aim to recruit at least 6 patients in each of the following BASRI lumbar spine categories:
- 0 or 1 (normal or suspicious changes)
- 2 (erosions, sclerosis or squaring with or without syndesmophytes or 2 or fewer vertebrae)
Show all 9Show fewer
- 3 (syndesmophytes on 3 or more vertebrae with fusion of at most 2 vertebrae)
- Age 18 years or older
- Diagnosis of AS by the modified New York criteria (5)
Who cannot join
- Inability to provide informed consent.
- BASRI lumbar spine score of 4 (complete fusion; 12)
- Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.
- History of allergic reactions to gadolinium-DPTA contrast used for MRI
- Anticipated unavailability for follow-up over 2 years
- Pregnancy
Show all 17Show fewer
- Onset of AS at age 16 or younger
- Spondyloarthropathy other than AS
- Severe scoliosis or other spinal malalignment that would complicate scan interpretation
- CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL
- Up to 35 patients will be studied.
- Inability to provide informed consent
- BASRI lumbar spine score of 4 (complete fusion)<TAB>
- Pregnancy
- Onset of AS at age 16 or younger
- Spondyloarthropathy other than AS
- Severe scoliosis or other spinal malalignment that would complicate scan interpretation
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
This study will evaluate: 1) whether computed tomography (CT) scanning is better than regular x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with ankylosing spondylitis; and 2) if CT can be used to determine how fast extra bone forms in the spine of these patients. Better ways to measure spinal fusion are needed to be able to evaluate the effectiveness of medicines in slowing or stopping its progression. CT uses x-rays to provide detailed pictures of the inside of the body and are valuable for detecting spinal abnormalities because of the precision with which it can show these structures. For the procedure, the patient lies on a table that moves into a large, donut-shaped scanner that can move around the body to take pictures at different angles, which are viewed on a computer monitor.
Patients 18 years of age and older with ankylosing spondylitis who are not currently taking or planning to receive treatment with anti-TNF alpha medications (etanercept, infliximab, adalimumab) for 1 year may be eligible for this study. Participants have eight clinic visits, scheduled at study entry and at 4, 8, 12, 16, 20, 24, and 48 months, at the NIH Clinical Center for the following procedures:
Read more
- Clinical assessment (all visits) - includes medical history and physical examination, measurement of spine flexibility with a tape measure and protractor, symptoms questionnaire
- Blood tests for measures of inflammation, including red blood cell sedimentation rate and C-reactive protein level (all visits)
- Urine pregnancy test in women of child-bearing age (visits 1, 4, 7, 8)
- X-rays of the pelvis, low back, and neck (visits 1, 4, 7)
- X-ray of the low back (visit 8)
- CT scan of the low back (visits 1, 4, 7)
- Magnetic resonance imaging (MRI) of the low back (visits 1, 4) - MRI combines a powerful magnet with an advanced computer system and radio waves to produce accurate, detailed pictures of organs and tissues. The patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. He or she can speak with a staff member via an intercom system at all times during the procedure. During the scan, a contrast dye (gadolinium) is injected into the bloodstream through a catheter (plastic tube inserted in a vein) to brighten the images.
In addition, participants will complete a symptoms questionnaire by mail every 4 months for 2 years between visits 7 and 8.
Read the detailed description
Spinal fusion is the clinical, radiological, and pathological hallmark of ankylosing spondylitis (AS). However, spinal fusion occurs slowly in AS. Serial radiographs rarely show changes over 2 years, and often 5 or more years are needed to demonstrate progression of spinal fusion. Methods that are more sensitive to changes in the extent of spinal fusion than plain radiographs are needed to test if any treatments can slow or halt spinal fusion in AS. The need for an improved measure of spinal fusion is heightened now that several new medications are available that have the potential to markedly decrease spinal inflammation in AS.
The goal of this pilot study is to test whether measurement of bone mineral density, bone volume, or bone mass at the annulus fibrosis of lumbar disc spaces by computed tomography (CT) can provide a reliable, valid, and sensitive measure of spinal fusion in patients with AS. Fifty-five participants will have lumbar spine CT scans at baseline, 12 months, and 24 months, lumbar spine magnetic resonance imaging at baseline and 12 months, and spinal radiographs at baseline, 12 months, 24 months, and 48 months. In addition, clinical assessments will be done every 4 months during the first 24 months. An option to perform only the baseline studies is also possible. No treatment is provided in the protocol. Reliability of image processing will be tested on repeated measurements of baseline scans. Reliability will also be assessed with repeat CT scans on up to 10 participants. Construct validity will be tested by correlation of CT measures with scores of plain radiographs, lumbar magnetic resonance imaging, and spinal range of motion. The sensitivity to change of the CT measures over 12 months and 24 months will be compared to those of two scoring systems based on plain radiographs.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Syndesmophyte, Natural History, Ankylosing Spondylitis, AS, Spondyloarthropathy, Spondyloarthritis
- Medical subject headings
- Spondylitis, Ankylosing, Spondylarthropathies, Spondylarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Syndesmophyte growth
syndesmophyte growth by CT
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2004 (estimated)
- Study start3 Dec 2004
- Primary completion18 Oct 2019
- Study completion13 Feb 2021
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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 63 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
- Robert A Colbert, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085995
- Sponsor's protocol ID
- 040205
- Other IDs
- 04-AR-0205
- Status last verified
- Apr 2026
- First submitted
- 18 Jun 2004
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not yet known
Publications
Keaveny TM. Biomechanical computed tomography-noninvasive bone strength analysis using clinical computed tomography scans. Ann N Y Acad Sci. 2010 Mar;1192:57-65. doi: 10.1111/j.1749-6632.2009.05348.x.
PubMed 20392218Simkin PA, Downey DJ, Kilcoyne RF. Apophyseal arthritis limits lumbar motion in patients with ankylosing spondylitis. Arthritis Rheum. 1988 Jun;31(6):798-802. doi: 10.1002/art.1780310617.
PubMed 3382452Cann CE, Genant HK, Kolb FO, Ettinger B. Quantitative computed tomography for prediction of vertebral fracture risk. Bone. 1985;6(1):1-7. doi: 10.1016/8756-3282(85)90399-0.
PubMed 3994856
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of Spinal Fusion in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT00085995
- Acronym / sponsor ID
- 040205
- Conditions
- Ankylosing Spondylitis
- Keywords
- Syndesmophyte, Natural History, Ankylosing Spondylitis, AS, Spondyloarthropathy, Spondyloarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 3 Dec 2004 (actual)
- Primary completion
- 18 Oct 2019 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 21 Jun 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.
This study will evaluate: 1) whether computed tomography (CT) scanning is better than regular x-rays for measuring changes in the stiffness, or fusion, of the spine in patients with ankylosing spondylitis; and 2) if CT can be used to determine how fast extra bone forms in the spine of these patients. Better ways to measure spinal fusion are needed to be able to evaluate the effectiveness of medicines in slowing or stopping its progression. CT uses x-rays to provide detailed pictures of the inside of the body and are valuable for detecting spinal abnormalities because of the precision with which it can show these structures. For the procedure, the patient lies on a table that moves into a large, donut-shaped scanner that can move around the body to take pictures at different angles, which are viewed on a computer monitor.
Patients 18 years of age and older with ankylosing spondylitis who are not currently taking or planning to receive treatment with anti-TNF alpha medications (etanercept, infliximab, adalimumab) for 1 year may be eligible for this study. Participants have eight clinic visits, scheduled at study entry and at 4, 8, 12, 16, 20, 24, and 48 months, at the NIH Clinical Center for the following procedures:
- Clinical assessment (all visits) - includes medical history and physical examination, measurement of spine flexibility with a tape measure and protractor, symptoms questionnaire
- Blood tests for measures of inflammation, including red blood cell sedimentation rate and C-reactive protein level (all visits)
- Urine pregnancy test in women of child-bearing age (visits 1, 4, 7, 8)
- X-rays of the pelvis, low back, and neck (visits 1, 4, 7)
- X-ray of the low back (visit 8)
- CT scan of the low back (visits 1, 4, 7)
- Magnetic resonance imaging (MRI) of the low back (visits 1, 4) - MRI combines a powerful magnet with an advanced computer system and radio waves to produce accurate, detailed pictures of organs and tissues. The patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. He or she can speak with a staff member via an intercom system at all times during the procedure. During the scan, a contrast dye (gadolinium) is injected into the bloodstream through a catheter (plastic tube inserted in a vein) to brighten the images.
In addition, participants will complete a symptoms questionnaire by mail every 4 months for 2 years between visits 7 and 8.
Detailed description
Spinal fusion is the clinical, radiological, and pathological hallmark of ankylosing spondylitis (AS). However, spinal fusion occurs slowly in AS. Serial radiographs rarely show changes over 2 years, and often 5 or more years are needed to demonstrate progression of spinal fusion. Methods that are more sensitive to changes in the extent of spinal fusion than plain radiographs are needed to test if any treatments can slow or halt spinal fusion in AS. The need for an improved measure of spinal fusion is heightened now that several new medications are available that have the potential to markedly decrease spinal inflammation in AS.
The goal of this pilot study is to test whether measurement of bone mineral density, bone volume, or bone mass at the annulus fibrosis of lumbar disc spaces by computed tomography (CT) can provide a reliable, valid, and sensitive measure of spinal fusion in patients with AS. Fifty-five participants will have lumbar spine CT scans at baseline, 12 months, and 24 months, lumbar spine magnetic resonance imaging at baseline and 12 months, and spinal radiographs at baseline, 12 months, 24 months, and 48 months. In addition, clinical assessments will be done every 4 months during the first 24 months. An option to perform only the baseline studies is also possible. No treatment is provided in the protocol. Reliability of image processing will be tested on repeated measurements of baseline scans. Reliability will also be assessed with repeat CT scans on up to 10 participants. Construct validity will be tested by correlation of CT measures with scores of plain radiographs, lumbar magnetic resonance imaging, and spinal range of motion. The sensitivity to change of the CT measures over 12 months and 24 months will be compared to those of two scoring systems based on plain radiographs.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinical sample
Key inclusion criteria (9 listed)
- Age 18 years or older
- Diagnosis of AS by the modified New York criteria
- Lumbar spine BASRI score of 0, 1, 2, or 3
- We will aim to recruit at least 6 patients in each of the following BASRI lumbar spine categories:
- 0 or 1 (normal or suspicious changes)
Key exclusion criteria (17 listed)
- Inability to provide informed consent.
- BASRI lumbar spine score of 4 (complete fusion; 12)
- Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.
- History of allergic reactions to gadolinium-DPTA contrast used for MRI
- Anticipated unavailability for follow-up over 2 years
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
Syndesmophyte growth
Time frame: 1 and 2 years
syndesmophyte growth by CT
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 16 Apr 2026.
- Background: PubMed 20392218Keaveny TM. Biomechanical computed tomography-noninvasive bone strength analysis using clinical computed tomography scans. Ann N Y Acad Sci. 2010 Mar;1192:57-65. doi: 10.1111/j.1749-6632.2009.05348.x.
- Background: PubMed 3382452Simkin PA, Downey DJ, Kilcoyne RF. Apophyseal arthritis limits lumbar motion in patients with ankylosing spondylitis. Arthritis Rheum. 1988 Jun;31(6):798-802. doi: 10.1002/art.1780310617.
- Background: PubMed 3994856Cann CE, Genant HK, Kolb FO, Ettinger B. Quantitative computed tomography for prediction of vertebral fracture risk. Bone. 1985;6(1):1-7. doi: 10.1016/8756-3282(85)90399-0.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. not yet known
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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.
Robert A Colbert, 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 9 inclusion and 17 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 16 Apr 2026. 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.
What does the primary outcome measure?
Syndesmophyte growth (time frame: 1 and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00085995, 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 16 Apr 2026.