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Monoclonal Antibodies

Tocilizumab (8 mg/kg) for Intermediate Uveitis (STOP-Uveitis Trial)

Phase 1 & 2
Waitlist Available
Led By Quan D Nguyen, MD, MSc
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration.
Awards & highlights

STOP-Uveitis Trial 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.

Eligible Conditions
  • Intermediate Uveitis
  • Panuveitis
  • Chorioretinitis

STOP-Uveitis Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 1, 3, 6, and 12 after therapy or at the time of rescue therapy administration. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of adverse events from baseline (BL) to month 6.
Secondary outcome measures
Frequency and severity of adverse events at month 12.
Other outcome measures
Percentage of patients with a decrease of ≥ 2 steps in vitreous haze or resolution of haze (for patients with 1+ haze at baseline) based on the National Eye Institute (NEI) scale at 1, 3, 6, and 12 months after therapy or at time of rescue.

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo

STOP-Uveitis Trial Design

2Treatment groups
Experimental Treatment
Group I: Tocilizumab (8 mg/kg)Experimental Treatment1 Intervention
Tocilizumab (8 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Group II: Tocilizumab (4 mg/kg)Experimental Treatment1 Intervention
Tocilizumab (4 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
FDA approved

Find a Location

Who is running the clinical trial?

University of NebraskaLead Sponsor
537 Previous Clinical Trials
1,143,918 Total Patients Enrolled
Quan D Nguyen, MD, MScPrincipal InvestigatorTruhlsen Eye Institute, University of Nebraska Medical Center
8 Previous Clinical Trials
332 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study
Quan Dong Nguyen, MD 2013. "Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01717170.
All > Uveitis
~3 spots leftby Apr 2025
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