Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
NCT ID: NCT01103024
Last Updated: 2020-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2010-12-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AIN457 300mg s.c every 2 weeks
AIN457
AIN457 300mg s.c every 4 weeks
AIN457
AIN457 150mg s.c every 4 weeks
AIN457
Placebo s.c every 2 weeks
Placebo
Interventions
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AIN457
AIN457
AIN457
Placebo
Eligibility Criteria
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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 study treatment in the extension study
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Countries
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Other Identifiers
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2009-015509-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457C2302E1
Identifier Type: -
Identifier Source: org_study_id
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