A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis (ENDURE)

NCT01090310 Phase 3 TERMINATED Results posted

This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Details

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	TERMINATED
Enrolment	86
Start date	2010-08
Completion	2011-07

Conditions

• Non-infectious Uveitis

Interventions

• AIN457
• Placebo

Primary outcomes

• The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline — Baseline to 52 weeks
  Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension

Countries

United States, Brazil, Germany, India, Israel, Spain, Switzerland, United Kingdom