Clinical Trial: Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study

Brief Summary: In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with non-infectious intermediate, posterior, or panuveitis.

Detailed Summary:
Sponsor: University of Nebraska

Current Primary Outcome: Frequency and severity of adverse events from baseline (BL) to month 6. [ Time Frame: Baseline (BL) to month 6. ]

Safety and tolerability of repeated Tocilizumab infusions in patients with non-infectious uveitis, as assessed by frequency and severity of adverse events from baseline (BL) to month 6.


Original Primary Outcome: Same as current

Current Secondary Outcome: Frequency and severity of adverse events at month 12. [ Time Frame: Baseline to Month 12 ]

Safety and tolerability of repeated Tocilizumab infusions in patients with non-infectious uveitis, as assessed by frequency and severity of adverse events at month 12.


Original Secondary Outcome: Same as current

Information By: University of Nebraska

Dates:
Date Received: October 26, 2012
Date Started: March 2013
Date Completion: December 2017
Last Updated: April 26, 2017
Last Verified: April 2017