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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT02593006
Eligibility Criteria:
Inclusion Criteria:
* Age less than 19 at baseline (if 18 or older, agrees to be followed for at least one year)
* Diagnosis of Arthritis per ACR definition.
* Arthritis present in one joint for a least six weeks
* At least 5 active joints at baseline
* Contraception if sexually active (male and female)
May have any of the following:
* RF+ polyarticular JIA
* RF- polyarticular JIA
* Extended oligoarticular JIA
* Psoriatic JIA
* Enthesitis related JIA
* Undifferentiated JIA
* Psoriasis
* Sacroiliitis
* Uveitis
* Enthesitis
* Prior treatments permitted:
* NSAIDS
* Hydroxychloroquine
* Intraocular / topical / intraarticular glucocorticoids
* IV or PO steroids if one of the below criteria are met:
--If treated ≤ 3 months prior to baseline: treatment cannot exceed 2 weeks
--If treated \> 3 months prior to baseline: any treatment course is permitted as long as treatment was completed 90 days prior to baseline
* Methotrexate started no more than 1 month prior to the baseline visit
* Biologics - received only 1 dose within 1 week of the baseline visit
Exclusion Criteria:
* Features consistent with systemic JIA
* Treatment with any medications for JIA aside from those listed above.
* Known inflammatory bowel disease
* Known celiac disease
* Known Trisomy 21
* History of or current malignancy
* Concomitant serious active or recurrent chronic bacterial, fungal or viral infection
* Significant organ system disorder limiting use of treatments for pJIA
* Live vaccine within a month prior to baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT02593006
Study Brief:
Protocol Section:
NCT02593006