EUCTR2009-011237-27-IT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 Beh?ets patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - ND
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
- •Inclusion Criteria Male and female subjects >18 years of age Patients with Beh?ets 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 Beh?ets disease at the time of screening are eligible for the study. The diagnosis of Beh?ets disease lies in the judgment of the investigator. Criteria for the diagnosis of Beh?ets disease according to the International Uveitis Study Group criteria and the Beh?ets Disease Research Committee criteria (complete or incomplete type) are provided Appendix 2. 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 screening). 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 with <2+ anterior chamber cell grade (intermediate or posterior uveitis) or >2+ vitreous haze 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 Beh?ets disease. Requirement for either of the following immunosuppressive therapies for at least 3 of the past 6 months for the treatment of or to prevent an exacerbation of ocular inflammation related to Beh?ets disease a. Prednisone or equivalent >10 mg daily b. The need for at least >1 periocular injection or >1 intravitreal corticosteroid injection in the study eye within the past 6 months (the last injection must have 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 at any time with chlorambucil or cyclophosphamide are not eligible for the study.) Patients not meeting the above specified criteria for immunomodulatory therapies are eligible for enrollment if they are intolerant to systemic immunomodulatory therapy as determined by the study investigator
- •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 criteria Ocular concomitant conditions/disease Subjects with infectious uveitis, uveitis due to other causes than Beh?ets disease, or uveitis of unknown etiology. Less severe (i.e. anterior) uveitis associated with Beh?ets disease Ocular treatments Treatment with intravitreal anti-VEGF agents administered to the study eye within 3 months prior to study screening Treatment with any injected or implantable corticosteroid releasing device (i.e. flucinolone acetonide implant, Retisert) in the study eye within the last 3 years. 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. Planned elective ocular surgery during the study. Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract, vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation of the safety or efficacy of the study treatment (i.e. uncontrolled glaucoma, toxoplasma scar, macular scarring). 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, etc.) Systemic conditions or treatments 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). History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years (except for non-melanoma skin cancer that has been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix, colon polyps with non-invasive malignancy that have been removed)
研究者
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