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

Primary Purpose

Uveitis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

AIN457

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AIN457 300mg s.c every 2 weeks

Arm Description

Outcomes

Primary Outcome Measures

Participants with adverse events as a measure of safety and tolerability

Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis

Mean time to achieve the criteria for clinically inactive posterior segment uveitis

Secondary Outcome Measures

Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment

Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment

Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457

Full Information

NCT ID

NCT01327664

First Posted

February 24, 2011

Last Updated

December 5, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01327664

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Withdrawn

Why Stopped

Study will not be initiated as planned.

Study Start Date

March 2011 (undefined)

Primary Completion Date

May 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Uveitis

Keywords

Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 300mg s.c every 2 weeks

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

AIN457

Primary Outcome Measure Information:

Title

Participants with adverse events as a measure of safety and tolerability

Time Frame

up to 36 months

Title

Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis

Time Frame

up to 36 months

Title

Mean time to achieve the criteria for clinically inactive posterior segment uveitis

Time Frame

up to 36 months

Secondary Outcome Measure Information:

Title

Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment

Time Frame

up to 36 months

Title

Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment

Time Frame

up to 36 months

Title

Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457

Time Frame

up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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