EUCTR2009-013901-33-FR进行中（未招募）不适用
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Population: Patients with intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease enrolled in the core study. In the extension study patients may elect to continue study treatments (Group 1) or only to complete the treatment-free safety follow-up period (Group 2).
- •Inclusion for Group 1 :
- •Patients who have completed the entire treatment period of the 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 a written, signed, and dated informed consent before any study assessment is performed.
- •Inclusion for Group 2 :
- •Patients who were randomized into 24-week core study and did not complete the treatment period or will not continue in the extension treatment phase.
- •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
排除标准
- •Exclusion for 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.
- •Active systemic infections during the last two weeks (exception: common cold) prior Visit16 that in the opinion of the study investigator or sponsor that would be a contraindication to additional treatment with AIN457.
- •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, (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.
- •?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.
- •There are no Exclusion criteria for Group 2.
研究者
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