Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT00085995
Eligibility Criteria:
* 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
9. Severe scoliosis or other spinal malalignment that would complicate scan interpretation
B. CROSS-SECTIONAL (RELIABILITY) STUDY PROTOCOL
Up to 35 patients will be studied.
INCLUSION CRITERIA:
1. Age 18 years or older
2. Diagnosis of AS by the modified New York criteria (5)
EXCLUSION CRITERIA:
1. Inability to provide informed consent
2. BASRI lumbar spine score of 4 (complete fusion)\<TAB\>
3. Pregnancy
4. Onset of AS at age 16 or younger
5. Spondyloarthropathy other than AS
6. Severe scoliosis or other spinal malalignment that would complicate scan interpretation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00085995
Study Brief:
Protocol Section:
NCT00085995