Clinical trial NCT01327664: Study to Evaluate the Long Term Use of Treatment With AIN457 for Uveitis
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Uveitis
Keywords: Quiescent uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Participants with adverse events as a measure of safety and tolerability
timeFrame: up to 36 months
measure: Proportion of patients achieving the criteria for clinically inactive posterior segment uveitis
timeFrame: up to 36 months
measure: Mean time to achieve the criteria for clinically inactive posterior segment uveitis
timeFrame: up to 36 months
Secondary outcomes:
measure: Proportion of patients experiencing clinically active posterior segment uveitis in patients discontinuing AIN457 treatment
timeFrame: up to 36 months
measure: Time to recurrence of clinically active posterior segment uveitis after discontinuation of AIN457 treatment
timeFrame: up to 36 months
measure: Time to resolution of a recurrence of clinically active posterior segment uveitis in patients discontinuing AIN457 and treated only with the reinitiation of AIN457
timeFrame: up to 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: