Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis
Stopped early · Not applicable
Conditions studied: Arthritis, Juvenile Rheumatoid, Still's Disease, Juvenile Onset
In brief
The purpose of this study is to see if tocilizumab is safe and effective for treating systemic onset Juvenile Idiopathic Arthritis (soJIA). Another purpose is to see if tocilizumab helps reduce the amount of steroids (prednisone) needed to control symptoms of soJIA.
Key facts
- Study ID
- NCT00868751
- Run by
- Tufts Medical Center
- People needed
- 1
- Starts
- 2009-03-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2017-05-15
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Tufts Medical Center/Floating Hospital for Children — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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