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

This study has been withdrawn prior to enrollment.

(Study will not be initiated as planned.)

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT01327664

First received: February 24, 2011

Last updated: March 31, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

February 24, 2011

Last Updated Date

March 31, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Participants with adverse events as a measure of safety and tolerability [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Mean time to achieve the criteria for clinically inactive posterior segment uveitis [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01327664 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Uveitis

Intervention ^ICMJE

Biological: AIN457

Study Arm (s)

Experimental: AIN457 300mg s.c every 2 weeks

Intervention: Biological: AIN457

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

125

Completion Date

Not Provided

Estimated Primary Completion Date

May 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01327664

Other Study ID Numbers ^ICMJE

CAIN457C2399, 2010-021239-15

Has Data Monitoring Committee

Not Provided

Responsible Party

External Affairs, Novartis Pharmaceuticals Corporation

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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