Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Uveitis

In brief

The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.

Key facts

Study ID

NCT01103024

Run by

Novartis

People needed

0

Starts

2010-12-01

Expected to finish

2011-02-01

Last updated by the study team

2020-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have completed the entire treatment period of the 28-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 a written, signed, and dated informed consent before study treatment in the extension study

You may not qualify if…

• 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Texas Retina Associates — Arlington, Texas, United States
• Novartis Investigative Site — London, Ontario, Canada
• Novartis Investigative Site — North York, Ontario, Canada
• Novartis Investigative Site — Ramat Gan, Israel
• Novartis Investigative Site — Bunkyō City, Japan
• Novartis Investigative Site — Fukuoka, Japan
• Novartis Investigative Site — Fukushima, Japan
• Novartis Investigational Site — Kyoto, Japan
• Novartis Investigative Site — Sapporo, Japan
• Novartis Investigative Site — Tochigi, Japan
• Novartis Investigative Site — Bern, Switzerland

Full record on ClinicalTrials.gov

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