JPRN-jRCTs061220030进行中（未招募）2 期
Prospective study of the efficacy and safety of mycophenolate mofetil in patients with noninfectious uveitis and scleritis
Kiuchi Yoshiaki0 个研究点目标入组 10 人开始时间: 2022年6月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Age at the time of consent acquisition is 18 years or older
- •2) Patients who can go to the outpatient clinic every 4 to 12 weeks after the start of administration
- •3) Patients who have written consent to participate in this study
- •4) Non-infectious uveitis (intermediate, anterior intermediate, posterior, panuveitis) with a history of at least one eye
- •5) At least one eye with active eye inflammation for 90 days or more, SUN criteria, over 2 cells in the anterior chamber, over 2 vitreous opacity, retinal choroidal lesions
- •6) Patients who are visiting our hospital for at least one of the following.
- •If there is an activity of eye inflammation even after administration of prednisolone, equivalent to 1
- •mg/ kg, for 4 weeks.
- •When the anti-inflammatory effect is obtained by oral prednisolone treatment equivalent to 0.5-1mg/ kg and the relapse of inflammation due to the gradual decrease in oral administration is within 90 days before registration.
- •If oral steroids are more than 10 mg/day are required 90 days before registration.
- •Uveitis that chronically requires immunosuppressive agents, Behcet's disease, polyfocal chorioretinitis,
- •retinal vasculitis, chronic recurrent stage Vogt Koyanagi Harada's disease, sympathetic ophthalmia,
- •When steroids cannot be used for a long time due to side effects.
- •7) Patients who fall under any of the following.
- •male (No need for contraception) / Women who consent to contraception before, during, and after discontinuation of this drug for 6 weeks / Women who are judged to be medically infertile.
排除标准
- •1) Infectious uveitis
- •2) Patients who cannot see through the fundus due to binocular cataract, corneal opacity, post-iris adhesion, etc.
- •3) Chronically low intraocular pressure in both eyes, IOP less than 5 mmHg, 3 months
- •4) Patients who underwent endovascular surgery within 3 months before the start of administration of this drug.
- •5) Patients who received immunosuppressive agents other than steroids within 12 months before the start of administration of this drug.
- •6) Patients positive for hepatitis virus and tuberculosis syphilis.
- •7) In patients with severe renal disease, serum Cr 1.5 mg / dL or higher or CKD stage 3b or higher.
- •8) Patients with systemic autoimmune disease.
- •9) Patients with the following complications, Liver disease, mental illness, seizure and paroxysmal disease, heart disease due to other causes.
- •10) Patients who have had serious side effects with immunosuppressants in the past.
- •11) Patients with malignant disease.
- •12) Patients who fall under the contraindications for MMF.
- •13) Patients who fall under at least one of the following.
- •White blood cells less than 2500 / uL, Platelets less than 75000 / uL, hemoglobin less than 9g / dL,
- •AST / ALT is more than twice the normal upper limit, Creatinine more than 1.5mg / dL
- •14) Pregnant or lactating females, females who may be pregnant or who wish to have children.
- •15) Patients who are participating in or willing to participate in other clinical studies while participating in this study.
- •16) When it is determined that it interferes with, limits, or confuses the evaluation specific to the clinical research plan.
- •17) Employees of the investigator or the implementing medical institution that are directly
- •involved in this research or other clinical research, or the family of such employees or the investigator.
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