Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis
Phase 3
Withdrawn
- Conditions
- Uveitis
- Interventions
- Biological: AIN457
- Registration Number
- NCT01327664
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AIN457 300mg s.c every 2 weeks AIN457 -
- Primary Outcome Measures
Name Time Method Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis up to 36 months Participants with adverse events as a measure of safety and tolerability up to 36 months Mean time to achieve the criteria for clinically inactive posterior segment uveitis up to 36 months
- Secondary Outcome Measures
Name Time Method 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 Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment up to 36 months