A 38-week extension to a 24-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis (ENDURE Study) - ENDURE, C2301E1

Conditions: Adjunctive therapy to standard-of-care for the treatment of patients with quiescent, non-infectious intermediate, posterior or panuveitis
MedDRA version: 12.0Level: LLTClassification code 10022941Term: Iridocyclitis

Registration Number: EUCTR2009-015508-24-GB

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 232

Inclusion Criteria

1. Patients who have completed the entire treatment period of the 24 week core study
2. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Inability or unwillingness to undergo repeated subcutaneous injections
2.Inability to comply with study or follow-up procedures.
3.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.
4.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)
5.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, (e.g., intra-uterine device plus condom, condom plus spermicidal gel, diaphragm plus condom, etc., hormone replacement as either oral or implantable is acceptable as one form), from the time of screening and for the duration of the study, through study completion and for 16 weeks after study drug discontinuation. [Note: Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), spermicides alone without condoms or cervical caps and withdrawal are not considered acceptable methods of contraception.]
•They are postmenopausal with an appropriate clinical profile (e.g, age appropriate, history of vasomotor symptoms) and had no regular menstrual bleeding for at least twelve (12) months prior to initial dosing. Menopause must be confirmed by a plasma FSH level of >40 IU/L at screening
•They have undergone reliable surgical sterilization at least six (6) months prior to initial dosing. Surgical sterilization procedures should be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History / Current Medical Conditions section of the CRF.
•Their career, lifestyle, or sexual orientation precludes intercourse with a male partner
•Partners have been sterilized by vasectomy or other reliable means
6.Male subjects must agree to use simultaneously two acceptable methods of contraception (e.g. condom plus spermicidal gel) for the entire duration of the study, up to the study completion visit, unless they have undergone a vasectomy more than six (6) months prior to first dosing. A vasectomy must be supported with clinical documentation made available to the sponsor and/or Principal Investigator and noted in the Relevant Medical History/ Current Medical Conditions sections of the CRF. Periodic abstinence or withdrawal are not acceptably adequate methods of contraception.
Reliable contraception must be maintained in men and women throughout the study and for 16 weeks after study drug discontinuation.
No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients.