Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uv… (NCT01103024) | Clinical Trial Compass
WithdrawnPhase 3
Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis
Stopped: Core study in non-infectious active uveitis was terminated
United States, Canada, Israel0Started 2010-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…