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Progression of Spinal Fusion in Ankylosing Spondylitis

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 363 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Primary completion date: Oct 18, 2019 Completion date: Feb 13, 2021v363 Show all 2 changesShow less
    • Completion date: Feb 13, 2021
  2. Minor 10 versions Re-verified since Dec 19, 2025, no change to tracked fieldsv353-v362
  3. Notable Start date: Jun 19, 2003 to Dec 3, 2004 Primary and study completion dates: Jun 26, 2018 to not statedv352 Show all 2 changesShow less
    • Primary and study completion dates: Jun 26, 2018 to not stated
  4. Minor Primary and study completion dates: Jun 26, 2018 Start date: Dec 3, 2004 to Jun 19, 2003v351 Show all 2 changesShow less
    • Start date: Dec 3, 2004 to Jun 19, 2003
  5. Minor 37 versions Re-verified since Oct 3, 2024, no change to tracked fieldsv314-v350
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00085995
Lead Sponsor National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Ankylosing Spondylitis
Enrollment 63 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov