NCT01904292

A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \<30 kg.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Subcutaneous 162 mg dose QW or Q2W for 52 weeks

Timeline

• Start date: 2013-08-15
• Primary completion: 2017-06-13
• Completion: 2017-06-13
• First posted: 2013-07-22
• Last updated: 2017-11-20

Locations

42 sites across 12 countries: United States, Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Russia, Spain, United Kingdom