Status:
COMPLETED
A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participan...
Eligibility Criteria
Inclusion
- Fulfils international league of associations for rheumatology (ILAR) classification criteria for sJIA
- Duration of sJIA symptoms lasting for at least 1 months subsequent to diagnosis of sJIA
- Presence of active disease as determined by the presence of:
- Greater than or equal to (\>=) 2 active joints at screening and baseline, with at least 14 consecutive days of temperature recordings, which may include the presence or absence of fever (\>=38 degree Celsius) during the time between screening and baseline; or
- \>=2 active joints at screening and baseline, with a fever \>=38 degree Celsius for at least 5 consecutive days during the time between screening and baseline; under these circumstances a participant does not need to complete a full 14 days of temperature diary entries to meet this inclusion criteria
- Not currently receiving corticosteroids (CS) or if taking oral CS like prednisone or equivalent, the dose should be less than or equal to (\<=) 1 milligram per kilogram per day (mg/kg/day) and the dose has remained stable for at least 2 weeks prior to baseline
- Not currently receiving methotrexate (MTX) or if taking MTX (together with either folic acid or folinic acid according to local standard-of-care), the dose has remained stable or has been discontinued for at least 4 weeks prior to baseline
- Not currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) or if taking NSAID, the dose has remained stable or has been discontinued for at least 2 weeks prior to baseline
- If the participants has received previous treatment with any of the following biologic agents, these must have been discontinued according to the following timelines prior to the baseline visit and are not permitted during the study:
- Etanercept must have been discontinued within \>= 2 weeks prior to baseline
- Anakinra must have been discontinued within \>= 4 days prior to baseline
- Abatacept must have been discontinued within \>= 12 weeks prior to baseline
- Infliximab or adalimumab must have been discontinued within \>= 8 weeks prior to baseline
- Canakinumab must have been discontinued within \>= 20 weeks prior to baseline
- Rilonacept must have been discontinued within \>= 6 weeks prior to baseline
- Golimumab must have been discontinued within \>= 10 weeks prior to baseline
- Certrolizumab pegol must have been discontinued within \>= 10 weeks prior to baseline
- History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and CS
Exclusion
- General
Key Trial Info
Start Date :
October 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01455701
Start Date
October 26 2012
End Date
July 13 2017
Last Update
November 4 2019
Active Locations (20)
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1
Children's National Medical Center; Pediatric Rheumatology
Washington D.C., District of Columbia, United States, 20010-2970
2
The University of Chicago;Department of Pediatrics
Chicago, Illinois, United States, 60649
3
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
4
The Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States, 02111