Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis Study (ENDURE)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 232

Inclusion Criteria

Group 1: Active treatment

Patients who have completed the entire treatment period of 24 week core study

Patients must be able to understand and communicate with the investigator and comply with the requirements for the study and must give written, signed and dated informed consent before starting treatment in the extension study.

Group 2: Patients in follow-up who will not receive drug in extension study

Patients who were randomized into the 24-week core study and did not complete the treatment period or will not continue treatment in the extension phase.

Exclusion Criteria

Group 1:
* Inability or unwillingness to undergo repeated subcutaneous injections.
* Inability to comply with study or follow-up procedures.
* Any medical or psychiatric condition which, in the investigator's opinion would preclude the participant from adhering to the protocol or completing the study per protocol.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
* Women of childbearing potential (WoCBP), defined as all women physiologically capable of becoming pregnant, UNLESS:
* They are using simultaneously double barrier or two acceptable methods of contraception.
* They are postmenopausal with an appropriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing.
* They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing.
* Their career, lifestyle, or sexual orientation precludes intercourse with a male partner.
* Partners have been sterilized by vasectomy or other reliable means.
No Exclusion criteria for Group 2.
Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence of active intermediate, posterior, or panuveitis defined by either: &#8805; 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of &#8805; 10 ETDRS lettersTimepoint: After baseline of CORE study

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Quality of Life/Patient reported outcome assessmentsTimepoint: Baseline to 52 weeks;Change in immunosuppressive medication score from baseline to 52 weeksTimepoint: Baseline to 52 weeks;Mean change in best corrected visual acuity from baselineTimepoint: Baseline to 52 weeks;Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeksTimepoint: Baseline to 52 weeks;Mean time to recurrence of active intermediate, posterior, or panuveitis from baselineTimepoint: Baseline to 52 weeks