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 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT06560606
Eligibility Criteria:
Inclusion Criteria:
Cohort 1: - Biologic Basis of JIA
* ≤18 years\*
* Active objective arthritis suspected to be JIA or diagnosed with JIA within 6 months of enrolment
* Treatment naïve except for NSAIDs, allowed to have received NSAIDS within 6 months of diagnosis
Cohort 2 - Start Biologics
* JIA diagnosis as per ILAR criteria (all subtypes)
* ≤18 years\*
* Active arthritis
* For sJIA, active disease not necessarily with arthritis.
* Time of start, restart or switch biologic therapy: e.g. failure, insufficient/partial response or intolerance
Cohort 3 - Stop Biologics
* JIA diagnosis as per ILAR criteria (all subtypes)
* ≤18 years\*
* Inactive disease
* Discontinuing/tapering biologics for inactive disease
Cohort 4: Extreme Phenotypes
* Unexplained systemic inflammation with arthritis/arthralgia as a part of manifestations
* High suspicion of genetic contribution
* Severely affected patients with difficult to control disease (ie failure of multiple biologics)
Exclusion Criteria:
Cohort 1 :
* Arthritis explained by another diagnosis
* Joint injections as previous treatment less than 4 weeks prior to enrollment
Cohort 2:
* Arthritis explained by any other cause
* Start on biologics as an indication for uveitis only
Cohort 3:
\- Tapering scheme \> 12 months to complete biologics stop
Cohort 4:
\- Arthritis explained by another diagnosis
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06560606
Study Brief:
Protocol Section:
NCT06560606