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:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT00014794
Eligibility Criteria:
INCLUSION CRITERIA:
18 years of age or greater.
Must meet the American College of Rheumatology's diagnostic criteria for RA(21).
Must have or have had synovitis in at least one knee characterized by tenderness, swelling, or effusion within 30 days prior to screening.
Women must test negative on a pregnancy test unless they are post-menopausal or surgically sterile.
EXCLUSION CRITERIA:
Patients with concurrent known bacterial, septic, or crystal-induced arthritis, or with other rheumatic diseases that may confound the analysis including but not limited to Lyme disease, psoriatic arthritis, spondylarthropathy, systemic lupus erythematosus, or reactive arthritis.
Patients who would be beyond the guidelines for radiation exposure from research studies within the past year.
Patients who exceed the size or weight limitations of the PET or MRI scanner.
Patients who suffer from claustrophobia or who have any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc), metal fragments in the eye, or shrapnel injuries.
Any musculoskeletal, neurological, or vascular condition that may alter the normal function and structure of knee joint of interest or will interfere the patient's ability to undergo study-related intervention and imaging.
Any clinically significant medical condition that, in the opinion of the investigator, would pose added risk for study participants.
History of allergic or non-allergic serious reaction to gadolinium, or H2 15O PET.
Pregnant women or nursing mothers.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00014794
Study Brief:
Protocol Section:
NCT00014794