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

Uveitis Clinical Trial

— SUPPORT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01327664
• Other study ID #: CAIN457C2399
• Secondary ID: 2010-021239-15
• Status: Withdrawn
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: December 5, 2013
• Start date: March 2011

Study information

• Verified date: December 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: SwissmedicGermany: Paul-Ehrlich-InstitutSpain: Spanish Agency of MedicinesItaly: Comitato Etico per la Sperimentazione Clinica dei Medicinali Dell'Azienda Ospedaliero -Universitaria Careggi di FirenzeTurkey: IEGM (The General Directorate of Pharmaceuticals and Pharmacy)United Kingdom: Medicines and Healthcare Products Regulatory AgencyBrazil: ANVISA (Agencia Nacional de Vigilancia Sanitaria)India: Drugs Controller General of IndiaIsrael: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Biological:
• AIN457

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants with adverse events as a measure of safety and tolerability		up to 36 months	Yes
Primary	Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis		up to 36 months	No
Primary	Mean time to achieve the criteria for clinically inactive posterior segment uveitis		up to 36 months	No
Secondary	Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment		up to 36 months	No
Secondary	Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment		up to 36 months	No
Secondary	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	No