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This study has been withdrawn prior to enrollment.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: December 5, 2013
Last verified: December 2013

February 24, 2011
December 5, 2013
March 2011
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01327664 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uveitis
Biological: AIN457
Experimental: AIN457 300mg s.c every 2 weeks
Intervention: Biological: AIN457
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
May 2014   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01327664
CAIN457C2399, 2010-021239-15
Not Provided
External Affairs, Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2013

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