EUCTR2009-011237-27-DE进行中（未招募）不适用
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 (SHIELD Study) - C2303
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •1.Male and female subjects =18 years of age
- •2.Patients with Behçet’s disease and with a history of recurrent uveitis in a least one eye. Patients with both active (experiencing an acute exacerbation) and quiescent (in between exacerbations) intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet’s disease at the time of screening are eligible for the study. The diagnosis of Behçet’s disease lies in the judgment of the investigator.
- •3.Documented evidence of =2 recurrent exacerbations of either intermediate uveitis, posterior uveitis or panuveitis in the study eye within the past 6 months (this could include the current exacerbation for patients having an acute exacerbation at enrollment). Exacerbations fulfilling the study inclusion criteria must have one or more of the following recorded in the patients medical record for each recurrent exacerbation:
- •a. =2+ vitreous haze score with <2+ anterior chamber cell grade (intermediate or posterior uveitis) or =2+ vitreous haze score with =2+ anterior chamber cell grade (panuveitis)
- •b. presence of retinal infiltrates or vasculitis or hemorrhages
- •c. documented =10 ETDRS letter or 2 line Snellen decrease in visual acuity attributed to ocular inflammation secondary to the recurrent exacerbation of Behçet’s disease.
- •4.Requirement for at least of the following immunosuppressive therapies for any 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Behçet’s disease
- •a. Prednisone or equivalent =10 mg daily
- •b. The need for at least =1 periocular injection or =1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not been given within 6 weeks of screening)
- •c. Treatment with cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid or methotrexate either as monotherapy or in combination with or without steroids. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are not eligible for the study.)
- •d. Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for the study if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator
- •5.Patient 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
排除标准
- •-Ocular concomitant conditions/disease
- •Subjects with infectious uveitis, uveitis due to other causes than Behçet’s disease, or uveitis of unknown etiology.
- •Less severe (i.e. anterior) uveitis associated with Behçet’s disease
- •-Ocular treatments, for instance
- •with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to screening.
- •with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months.
- •Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle.
- •Current use of or likely need for systemic medications known to be toxic to the lens,
- •retina, or optic nerve (e.g. deferoxamine, chloroquine, ethambutol)
- •-Systemic conditions or treatments, for instance
- •Treatment with any live or live-attenuated vaccine (including vaccine for varicella-zoster virus or measles) within 2 months prior to screening.
- •Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening and no prior treatment with AIN457.
- •Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to enrollment.
- •Active systemic infections during the last two weeks (exception: common cold) prior to screening.
- •Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at an unacceptable risk for participation in an immunomodulatory therapy.
- •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.
- •-Compliance/Administrative, for instance
- •Inability or unwillingness to undergo repeated subcutaneous injections
- •Inability or unwillingness to receive treatment with oral corticosteroids if recommended by the study investigator.
- •Participation in any other clinical investigation within 4 weeks prior to screening (or longer if required by local regulations), and for any other limitation of participation based on local regulations.
- •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 serum pregnancy test (hCG>5mIU/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, spermicidal gel plus condom, 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. 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 appropiriate clinical profile and had no regular menstrual bleeding for at least twelve (12) months pr
研究者
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