Study Stopped
Study will not be initiated as planned.
Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis
SUPPORT
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
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2011
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedDecember 6, 2013
December 1, 2013
3.2 years
February 24, 2011
December 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Participants with adverse events as a measure of safety and tolerability
up to 36 months
Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
up to 36 months
Mean time to achieve the criteria for clinically inactive posterior segment uveitis
up to 36 months
Secondary Outcomes (3)
Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment
up to 36 months
Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment
up to 36 months
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
Study Arms (1)
AIN457 300mg s.c every 2 weeks
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 24, 2011
First Posted
April 1, 2011
Study Start
March 1, 2011
Primary Completion
May 1, 2014
Last Updated
December 6, 2013
Record last verified: 2013-12