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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03414502
Eligibility Criteria:
INCLUSION CRITERIA:
* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria
* Morning stiffness for at least 1 hour for at least 6 weeks
* Swelling of 3 or more joints for at least 6 weeks
* Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks
* Symmetric joint swelling
* Hand x-rays with erosions or bony decalcifications
* RA nodules
* Rheumatoid factor (RF) positive
* \>19 yrs old at RA diagnosis
* Active disease with at least 1 swollen joint
* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)
* If on other DMARDS, must be on stable dose for ≥ 6 wks
* If on glucocorticoids, must be on stable dose for 2 wks (\< 10mg of Prednisone/day or equivalent)
* Able to adhere to study visit schedule: enrollment (8 wks \& 16 wks +/- 2 wks)
* Hemoglobin (Hgb) \> 9g/dl
* Platelets \>100
* Creatinine \<1.6
* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit
* Albumin up to 1.0 g/dL below lower limit of normal
EXCLUSION CRITERIA:
* Pregnant or breastfeeding women
* Men and women of child bearing potential unwilling to practice effective method of contraception
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03414502
Study Brief:
Protocol Section:
NCT03414502