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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT00792233
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of polyarticular JIA (rheumatoid factor + and rheumatoid factor -) or extended oligo JIA by the International League of Associations for Rheumatology (ILAR) criteria
* Receiving therapy with one of the currently available anti-TNF biologics: infliximab, etanercept, or adalimumab
* Absence of any of the FDA label exclusions for anti-TNF therapy
* Receiving slit lamp exams performed at regular intervals in accordance with the published American Academy of Pediatrics guidelines
* Baseline hemoglobin \>10 g/dl
* Absence of joints with active arthritis, using the American College of Rheumatology (ACR) definition of "active joint"
* Absence of fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA
* Absence of active uveitis, as per an exam by an ophthalmologist
* Normal erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP); if above normal range, must be not attributable to JIA
* Physician's global assessment of disease activity indicating absence of disease activity, defined as the best score obtainable on the scale used
* Duration of morning stiffness less than or equal to 15 minutes
Exclusion Criteria:
* Diagnosis of a type of JIA other than polyarticular JIA
* Diagnosis of another inflammatory disease that may affect laboratory results or ability to discontinue anti-TNF biologic therapy
* Concurrent treatment with any biologic agent other than infliximab, etanercept, or adalimumab
* previous treatment with rituximab
* concurrent treatment for JIA with corticosteroids \>0.2 mg/kg/day OR \>10 mg/day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
20 Years
Study:
NCT00792233
Study Brief:
Protocol Section:
NCT00792233