NCT01455701

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)

A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab will be administered as indicated in the arm description.

Timeline

• Start date: 2012-10-26
• Primary completion: 2016-07-28
• Completion: 2017-07-13
• First posted: 2011-10-20
• Last updated: 2019-11-04

Locations

20 sites across 8 countries: United States, Argentina, Belgium, Canada, Germany, Hungary, Poland, Spain

Regulatory

• FDA-regulated drug study