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NCT00085995 · ClinicalTrials.gov registry record
Progression of Spinal Fusion in Ankylosing Spondylitis
A clinical trial, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- 63
- Enrollment target
NCT00085995: Completed study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
NCT00085995 is a clinical trial that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 63 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00085995 has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- 63 participants
- Enrollment target
Study 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. 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 n
Primary Outcome
syndesmophyte growth by CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2004-12-03 |
| Est. Completion | 2021-02-13 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
What the finished NCT00085995 record still lists
NCT00085995 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 63 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00085995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00085995 about?
NCT00085995 is a clinical study titled "Progression of Spinal Fusion in Ankylosing Spondylitis". 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...
What is the current status of trial NCT00085995?
This trial is currently completed. The enrollment target is 63 participants. The study started on 2004-12-03. Estimated completion is 2021-02-13.
Who is sponsoring clinical trial NCT00085995?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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