Juvenile Idiopathic Arthritis
Conditions
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. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.
Interventions
DRUGTocilizumab
Tocilizumab will be administered as indicated in the arm description.
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
Inclusion criteria
* 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: 1. 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. \>=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: 1. Etanercept must have been discontinued within \>= 2 weeks prior to baseline 2. Anakinra must have been discontinued within \>= 4 days prior to baseline 3. Abatacept must have been discontinued within \>= 12 weeks prior to baseline 4. Infliximab or adalimumab must have been discontinued within \>= 8 weeks prior to baseline 5. Canakinumab must have been discontinued within \>= 20 weeks prior to baseline 6. Rilonacept must have been discontinued within \>= 6 weeks prior to baseline 7. Golimumab must have been discontinued within \>= 10 weeks prior to baseline 8. 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 criteria
General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Serum Concentration (Cmax) of Tocilizumab | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) | Pharmacokinetic profile of tocilizumab is evaluated in terms of model predicted Cmax at steady state. Pharmacokinetic-evaluable population includes all participants who provided at least one serum pharmacokinetic sample with valid concentration data. |
| Minimum Serum Concentration (Cmin) of Tocilizumab | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) | Pharmacokinetic profile of tocilizumab is evaluated in terms of observed Cmin at day 85. Pharmacokinetic-evaluable population. |
| Model predicted Area Under the Serum Concentration-Time Curve from Time Zero to End of Dosing (AUCtau) of Tocilizumab | Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour) | AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval (2 weeks). Pharmacokinetic-evaluable population. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs | Baseline up to end of the study (up to approximately 60 weeks) |
Countries
Argentina, Belgium, Canada, Germany, Hungary, Poland, Spain, United States
Outcome results
None listed