Protocol Details

Progression of Spinal Fusion in ankylosing Spondylitis

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	04-AR-0205
Sponsoring Institute	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Max Age: N/A
Referral Letter Required	No
Population Exclusion(s)	Children
Special Instructions	Currently Not Provided
Keywords	Computerized Tomography; Magnetic Resonance Imaging; Health Outcomes
Recruitment Keyword(s)	ankylosing Spondylitis; AS; Spondyloarthropathy; Spondyloarthritis
Condition(s)	Spondylitis, ankylosing
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Arthritis and Musculoskeletal and Skin Diseases

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.

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Eligibility

A. LONGITUDINAL STUDY PROTOCOL:

Fifty-five patients will be studied.

INCLUSION CRITERIA:

1. Age 18 years or older

2. Diagnosis of AS by the modified New York criteria

3. 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)

- 3 (syndesmophytes on 3 or more vertebrae with fusion of at most 2 vertebrae)

EXCLUSION CRITERIA:

1. Inability to provide informed consent.

2. BASRI lumbar spine score of 4 (complete fusion; 12)

3. Contraindication to MRI scanning based on the NMR Center MRI Safety Screening Questionnaire or size or weight limitations of the scanner.

4. History of allergic reactions to gadolinium-DPTA contrast used for MRI

5. Anticipated unavailability for follow-up over 2 years

6. Pregnancy

7. Onset of AS at age 16 or younger

8. Spondyloarthropathy other than AS

B. CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL

Up to 10 patients will be studied.

INCLUSION CRITERIA:

1. Age 18 years or older

2. Diagnosis of AS by the modified New York criteria (5)

3. Lumbar spine BASRI score of 2, or 3 (i.e. presence of at least one syndesmophyte)(12)

EXCLUSION CRITERIA:

1. Inability to provide informed consent

2. BASRI lumbar spine score of 0, 1, or 4 (complete fusion)

3. Pregnancy

4. Onset of AS at age 16 or younger

5. Spondyloarthropathy other than AS

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Citations:

Russell AS, Computer assisted tomography of the apophyseal changes in patients with ankylosing spondylitis. J Rheumatol.1986 Jun;13(3):581-5.

Simkin PA, Apophyseal arthritis limits lumbar motion in patients with ankylosing spondylitis. Arthritis Rheum. 1988 Jun;31(6):798-802.

Viitanen JV, Correlation between mobility restrictions and radiologic changes in ankylosing spondylitis. Spine. 1995 Feb 15;20(4):492-6.

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Contacts:

Principal Investigator	Referral Contact	For more information:
Michael M. Ward, M.D. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health 10 CENTER DRIVE BG 10 CRC RM 4-1339 MSC 1468 BETHESDA MD 20892-1468 (301) 496-7263 wardm1@mail.nih.gov	Eileen D. Lange, R.N. National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institutes of Health Building 10 Room 6N226 10 Center Drive Bethesda, Maryland 20892 (301) 435-8434 langeeil@mail.nih.gov	Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00085995

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