Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study
Part of paid clinical trials in Omaha, Nebraska.
- Sponsor
- University of Nebraska
- Study ID
- NCT01717170
- Phase
- PHASE1/PHASE2
- Status
- Unknown
Conditions
- Intermediate Uveitis
- Pan-uveitis
- Posterior Uveitis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab — DRUGTocilizumab (4 mg/kg or 8 mg/kg)
Study Details
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.
Key Dates
- Start date
- Mar 31, 2013
- Status verified
- Apr 2017
- Primary completion
- Jun 30, 2017
- Completion
- Dec 31, 2017
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Tocilizumab (4 mg/kg)Tocilizumab (4 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
- Experimental: Tocilizumab (8 mg/kg)Tocilizumab (8 mg/kg) as an intravenous infusion over 1 hour at day 0, 30, 60, 90, 120, and 150.
Primary Outcome Measure
Frequency and severity of adverse events from baseline (BL) to month 6. [ Time Frame: Baseline (BL) to month 6. ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Truhlsen Eye Institute, University Of Nebraska Medical Center | Omaha | Nebraska | 68105 | - |