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

Novartis

Status and phase

Withdrawn

Phase 3

Conditions

Uveitis

Treatments

Biological: AIN457

Study type

Interventional

Funder types

Industry

Identifiers

NCT01327664

2010-021239-15 (EudraCT Number)

CAIN457C2399

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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