Status:
TERMINATED
Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis
Lead Sponsor:
Tufts Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Arthritis, Juvenile Rheumatoid
Still's Disease, Juvenile Onset
Eligibility:
All Genders
2-16 years
Phase:
NA
Brief Summary
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 am...
Detailed Description
Systemic onset Juvenile Idiopathic Arthritis (soJIA) is a type of arthritis (inflammation of the joints) that occurs with other symptoms including fever, swollen lymph nodes (glands), rash, and body a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00868751
Start Date
March 1 2009
End Date
June 1 2010
Last Update
May 15 2017
Active Locations (1)
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1
Tufts Medical Center/Floating Hospital for Children
Boston, Massachusetts, United States, 02111