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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT00072657
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of RA as defined by the American College of Rheumatology (ACR) and consistent with revised criteria for RA
* Stable disease-modifying drug regimen for 3 months prior to study entry, with no change in drug dosage for at least 3 months prior to study entry
* Relatively stable disease course for 3 months prior to study entry
* If treated with corticosteroids, must be on a stable dosage for 3 months prior to study entry
* If taking prednisone, must be on a dosage less than or equal to 10 mg/day or equivalent
* Resides in Greater Los Angeles area
Exclusion Criteria:
* Inactive RA conditions defined as "in remission"
* Experiencing frequent, severe disease flares that require changes in primary disease-modifying regimen
* Serious medical conditions, including: diabetes, congestive heart failure, renal failure requiring specific treatment, cancer (unless cured for period of 5 years or more), unregulated endocrine disorders (including thyroid disorders), chronic uncontrolled infection, or any uncontrolled medical condition that may interfere with the study
* Use of analgesics (e.g., opioids) other than acetaminophen or non-steroidal anti-inflammatory agents prescribed for RA treatment, tramadol (Ultram) or Tylenol with codeine on an as-needed basis, or propoxyphen (Darvocet, Wygesic)
* Use of oxycodone (Percocet), hydrocodone (Vicodin), morphine, or hydromorphone (Dilaudid)
* Use of high levels of methotrexate (greater than 7.5 mg)
* Use of nitrogen mustard, cyclosporine, monoclonal antibodies, or cyclophosphamide within the 6 months prior to study entry
* Serious psychiatric conditions, such as bipolar disorder, psychotic disorders, or organic brain syndromes
* At risk for suicide
* Dependent on canes, walkers, or other assistive devices
* Unable to commit to study schedule/itinerary or unwilling to be assigned to any of the 3 treatment groups
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00072657
Study Brief:
Protocol Section:
NCT00072657