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Your journey
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More info
You can access this
clinical trial
if you have
Juvenile Idiopathic Arthritis
and you are
between 2 and 17
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

PART1 Participants in Part 1 (Run-in-Phase) of study will receive Tocilizumab (TCZ) (RoActemra/Actemra) 12 milligrams per kilogram (mg/kg) or 8 mg/kg intravenously (IV) every 2 weeks (Q2W) for up to 24 weeks. Participants who experience a laboratory abnormality during part 1 may be eligible to move into Part 2 of the study. PART 2 This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose frequency in participants with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing, that has since resolved. Participants will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 5 consecutive infusions, participants who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.

Provided treatments

  • Drug: Tocilizumab

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01734382. The sponsor of the trial is Hoffmann-La Roche and it is looking for 40 volunteers for the current phase.
Official trial title:
A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With Tocilizumab