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 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT01548768
Eligibility Criteria:
For RA patients (150 patients):
INCLUSION CRITERIA
* Diagnosis of Rheumatoid Arthritis by 2010 American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR) diagnostic criteria
* Age\>18 years old
* Moderate to high RA disease activity defined by a Clinical Disease Activity Index (CDAI) of \>10
* Stable dose of Methotrexate for 6 weeks prior to enrollment
* Stable doses of Nonsteroidal anti-inflammatory drug (NSAID) and prednisone (if already taking these medications) for 2 weeks prior to study
EXCLUSION CRITERIA
* Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)
* Contraindications to having a PET-CT scan or receive adenosine or Fludeoxyglucose (FDG)
* Active treatment for Cancer
* Uncontrolled hypertension
* Diabetes
* Smoking
* Treatment with a TNF inhibitor or other biologic currently or within the last 6 months
* Current treatment with "Triple Therapy" or within the last 2 months
* Untreated positive purified protein derivative (PPD) tuberculosis skin test or active tuberculosis
* History of Lymphoma and Melanoma
* Ejection Fraction (EF) \< 40% (if not known in advance then the Study Visit I Echocardiogram results will be used to exclude the patient from randomization and follow up)
* Change in NSAID/Prednisone dosage in last 2 weeks
* Participation in other research studies involving imaging/radiation exposure
For non-RA subjects (25 controls):
INCLUSION CRITERIA
* Age\>18 years old
* Absence of diagnosis of RA
EXCLUSION CRITERIA
* Prior self reported or physician diagnosed CV event (MI; angina; stroke or Transient Ischemic Attach (TIA); Heart Failure (HF); prior CV procedure (e.g., coronary artery bypass graft, angioplasty, valve replacement, pacemaker)
* Contraindications to having a PET-CT scan or receive adenosine or FDG
* Uncontrolled hypertension
* Participation in other research studies involving imaging/radiation exposure
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01548768
Study Brief:
Protocol Section:
NCT01548768