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Withdrawn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
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring Quiescent uveitis, intermediate uveitis, panuveitis, posterior uveitis, uveitis
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
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
No
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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