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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT00868751
Eligibility Criteria:
Inclusion Criteria:
* Systemic Juvenile Idiopathic Arthritis according to ILAR criteria (2001)
* Duration of disease ≥ 6 months since onset
* Presence of active disease as determined by the presence of at least 5 active joints, OR at least 2 active joints if receiving prednisone at a dose \> 0.2 mg/kg/day or \> 10 mg/day (whichever is less)
* Incomplete prior response to methotrexate treatment for at least 3 months at a minimum dose of 15 mg/M2/week, or intolerance to methotrexate
* Discontinued treatment with other biologics prior to first tocilizumab infusion, for approximately two pharmacokinetic half-lives as per specific biologic (e.g. 48 hours for anakinra, 7 days for etanercept)
* Not receiving corticosteroids, OR taking oral corticosteroids and the dose has remained stable for 1 week prior to the first tocilizumab infusion at ≤ 2 mg/kg/day prednisone or prednisolone and no more than 80 mg/day
Exclusion Criteria:
* Concomitant administration of biologic therapies
* Serum creatinine \>1.5 ULN (upper limits normal)
* AST or ALT \> 1.5 ULN
* Total bilirubin \> 1.3 mg/dL
* Platelet count \< LLN (lower limits normal)
* Hemoglobin \< 6.0 g/dL
* WBC count \< 5,000/mm3
* Neutrophil count \< 2,000/ mm3
* Fibrinogen \< LLN
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT00868751
Study Brief:
Protocol Section:
NCT00868751