CTRI/2010/091/000479未知3 期
A 28-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study to Assess AIN457 Versus Placebo in Inducing and Maintaining Uveitis Suppression in Adults With Active, Non-infectious, Intermediate, Posterior or Panuveitis Requiring Immunosuppression (INSURE Study)
Novartis Healthcare Pvt Ltd7 个研究点 分布在 1 个国家目标入组 208 人开始时间: 待定
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 208
- 试验地点
- 7
- 主要终点
- Mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier.
研究概览
简要总结
Target number of patients from India is 34.FPFV planned for the study is 10-Sep-2010.No patients screened from India
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 0.00 Day(s)（—）
- 性别
- All
入选标准
- •Male and female subjects greater than or equal to 18 years of age.
- •Where relevant, parents will also sign the informed consent according to local laws and regulations.
- •Patients with diagnosis of chronic non infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
- •Evidence of active intermediate, posterior or panuveitis (grade greater than or equal to 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
- •Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis • Prednisone or equivalent greater than or equal to 10 mg daily at any time within the past 3 months • Greater than or equal to 1 periocular injection or greater than or equal to 1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening) • Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months.
- •(Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study) • Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator
- •Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed, and dated informed consent before any study assessment is performed.
排除标准
- •Ocular concomitant conditions or disease
- •Patients receiving or that may require prednisone (or equivalent) greater than or equal to 1.5 mg/kg/day for the treatment of their active uveitis.
- •2.Patients with a primary diagnosis of Behçets disease, anterior uveitis, or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (e.g. punctuate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR)
- •Patients with infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma).
- •Ocular treatments
- •Treatment with intravitreal antiVEGF agents administered to the study eye within 3 months prior to screening.
- •Treatment 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.
- •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 (e.g. 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
- •Any previous treatment with AIN457
- •Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening.
- •No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial.
- •Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening.
- •Treatment with any live or live attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening.
- •No treatment with live or live attenuated vaccines will be allowed during the course of the clinical trial.
- •Active systemic infections during the last two weeks prior to screening (exception.
- •common cold)
- •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.
- •Systemic or extraocular disease that would contraindicate long-term immunosuppression, especially infectious diseases such as • any active, chronic or localized infection • a history of an infectious disease that can spontaneously reemerge or that is impossible to completely cure, such as histoplasmosis, toxoplasmosis, malaria, viral hepatitis, and HIV AIDS • history of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TBGold test.
- •Patients with evidence of latent tuberculosis may enter the trial after evaluation
- •Systemic or extraocular disease that would contraindicate long term immunosuppression, especially infectious diseases such as • any active, chronic or localized infection • a history of an infectious disease that can spontaneously re-emerge or that is impossible to completely cure, such as histoplasmosis, toxoplasmosis, malaria, viral hepatitis, and HIV AIDS • history of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis infection as defined by either a positive PPD skin test or a positive QuantiFERON TBGold test.
- •by a appropriate specialist and after sufficient treatment has been initiated according to local regulations or standard of care
- •History of lymphoproliferative disease or any known malignancy or history of malignancy within the past 5 years of any organ system, treated or untreated, whether or not there is evidence of local recurrence or metastases (except for non-melanoma skin cancer that has been treated with no evidence or recurrence in the past 3 months, carcinoma in situ of the cervix or colon polyps with non invasive malignancy that have been removed).
- •History of ongoing drug or alcohol abuse within the 6 months prior to screening or clinical evidence of such abuse or clinical suspicion of such abuse.
- •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.
结局指标
主要结局
Mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier.
时间窗: baseline to 28 weeks
次要结局
- ? Proportion of responders with no recurrence of active intermediate, posterior, or panuveitis in the study eye at 28 weeks(baseline to 28 weeks)
- ? Change from baseline in Quality of Life/Patient reported outcome assessments(baseline to 28 weeks)
- ? Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 28 weeks(baseline to 28 weeks)
- ? Mean change in best corrected visual acuity from baseline to 28 weeks(baseline to 28 weeks)
- ? change in immunosuppressive medication score from baseline to Week 28(baseline to 28 weeks)
研究者
研究点 (7)
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