Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis (SUPPORT)

A Multicenter, Open-label Study to Evaluate the Long Term Clinical Use of Treatment With AIN457 in Patients Completing Clinical Trials Investigating AIN457 for the Treatment of Non-infectious Intermediate, Posterior or Panuveitis

This study will provide patients who have completed the AIN457 Phase II and Phase III clinical trials in non-infectious uveitis continued access to treatment with AIN457 while collecting safety data and information on long term clinical use of treatment with AIN457.

Study Overview

• Status: Withdrawn
• Conditions: Uveitis
• Intervention / Treatment: Biological: AIN457

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give a written, signed, and dated informed consent before any study assessment is performed
• Patient is currently enrolled in CAIN457A2208 or has completed the core and extension study treatment periods in the ongoing AIN457 phase III clinical trial Studies (e.g., CAIN457C2301 and CAIN457C2301E1)
• Willingness to discontinue AIN457 or be weaned from standard of care immunosuppressive therapy if recommended by the study investigator

Exclusion Criteria:

• Need for treatment with ocular procedures or systemic medications prohibited in this study including an alkylating agent or another biologic therapy other than AIN457
• Pregnant or nursing (lactating) women
• Women of childbearing potential unwilling to use protocol defined acceptable methods of contraception throughout the study and for 16 weeks after study drug discontinuation

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AIN457 300mg s.c every 2 weeks	Biological: AIN457

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Participants with adverse events as a measure of safety and tolerability	up to 36 months
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis	up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis	up to 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment	up to 36 months
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment	up to 36 months
Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457	up to 36 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: uveitis; intermediate uveitis; panuveitis; posterior uveitis; Quiescent uveitis
• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis
• Other Study ID Numbers: CAIN457C2399; 2010-021239-15 (EudraCT Number)