NCT01829295已完成3 期
First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 7
- 主要终点
- Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)
研究概览
简要总结
In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) Uveitis Trial, the investigators propose to establish which immunosuppressive therapy, methotrexate or mycophenolate mofetil, is more effective as a first-line, corticosteroid-sparing agent for the treatment of non-infectious uveitis in a block-randomized, observer-masked, comparative effectiveness trial.
详细描述
This is a randomized comparative effectiveness trial to determine which treatment, methotrexate or mycophenolate mofetil, is more effective as first-line corticosteroid-sparing treatment for patients with non-infectious intermediate, posterior and panuveitis requiring corticosteroid-sparing therapy. The primary outcome is treatment success assessed at the 6 month visit (Phase 1, 0-6 months). If patients are a treatment success, they continue on the medication for another 6 months (Phase 1, 6-12 months). Patients who are a treatment failure can crossover to the other medication (Phase 2, 0-6 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All the following criteria must be met at enrollment:
- •Historical non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye
- •Active inflammation within the last 180 days, defined by the presence of any of the following (in at least one eye) according to Standardization of Uveitis Nomenclature (SUN) criteria:
- •≥ 2+ anterior chamber cells
- •≥ 2+ vitreous haze
- •active retinal or choroidal lesions
- •Active inflammation at enrollment, defined by the presence of any of the following (in at least one eye) according to SUN criteria:
- •≥1+ anterior chamber cells and/or
- •≥1+ vitreous haze and/or
- •active retinal/choroidal lesions
- •At least one of the following criteria must be met before or at enrollment:
- •Active inflammation after 4 weeks of high-dose (1mg/kg prednisone equivalent) corticosteroid treatment or 4 weeks following a regional corticosteroid injection
- •Treatment with oral corticosteroids resulting in a reduction of inflammation, followed by an increase in inflammation (of at least 1 grade in anterior chamber cells or vitreous haze or a change of non-active to active lesions) when corticosteroid is tapered, in the 180 weeks prior to enrollment
- •Active inflammation after long-acting corticosteroid injection 4 weeks to 180 days prior to enrollment
- •Active inflammation after treatment with >10mg/day oral prednisone for at least the past 90 days prior to enrollment
- •Known chronic condition necessitating corticosteroid-sparing immunosuppressive treatment: Behcet's disease with posterior segment involvement, multifocal choroiditis with panuveitis, serpiginous choroidopathy, birdshot retinochoroidopathy, diffuse retinal vasculitis, Vogt-Koyanagi-Harada with bullous serous retinal detachments and/or choroidal detachments, sympathetic ophthalmia. No prior therapy required for these patients
- •Willingness to start corticosteroid treatment at 1mg/kg or 60mg a day of prednisone, whichever is less
- •Willingness to limit alcohol consumption
- •Willingness to use an acceptable method of contraception during the study period (i.e. pharmacologic medications, devices, barrier methods) or abstinence.
排除标准
- •Any of the following
- •Any infectious cause of uveitis
- •Prior immunosuppressive therapy other than corticosteroids in the past 12 months
- •Prior intolerability or safety issues with methotrexate or mycophenolate mofetil
- •Prior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil
- •Prior biologic therapy at any time
- •Media opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes
- •Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes
- •Periocular or intravitreal corticosteroid injection in the past 4 weeks
- •Fluocinolone acetonide implant in either eye in < 3 years
- •Intraocular surgery in < 30 days, or planning on getting surgery within the next 6 months
- •Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye
- •< 16 years of age at enrollment
- •Planning to conceive during the study period, pregnant or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal is mandatory)*
- •Any history of cancer (If a patient has a history of non-melanoma skin cancer they can still be considered for inclusion in this study, provided it is not currently active).
- •Systemic autoimmune disease anticipated to dictate treatment course
- •Abnormal Complete blood count (≤ 2,500 white blood cells and/or ≤ 75,000 platelets and/or ≤9 hemoglobin) within 4 weeks prior to enrollment*
- •Abnormal alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal for the lab and/or creatinine ≥ 1.5 within 4 weeks prior to enrollment*
- •Evidence of active tuberculosis, HIV infection, syphilis, or hepatitis B or C (patients must have a tuberculin skin test, or interferon-gamma release assay, a chest radiograph, Rapid plasma reagin / Venereal disease research laboratory test (RPR/VDRL), fluorescent treponemal antibody absorption test (FTA-ABS), or other treponemal tests, Hepatitis B surface antigen, Hepatitis C antibody tests, and HIV test within 90 days prior to enrollment)**
- •*Testing required within 4 weeks prior to enrollment; **Testing required within 90 days prior to enrollment.
研究组 & 干预措施
Methotrexate
Experimental
oral methotrexate
干预措施: Methotrexate (Drug)
Methotrexate
Experimental
oral methotrexate
干预措施: Prednisone (Drug)
Mycophenolate Mofetil
Experimental
oral mycophenolate mofetil
干预措施: Mycophenolate mofetil (Drug)
Mycophenolate Mofetil
Experimental
oral mycophenolate mofetil
干预措施: Prednisone (Drug)
结局指标
主要结局
Number of Participants Achieving Treatment Success at 6 Months (Phase I, 0-6 Months)
时间窗: 6 Months
Controlled ocular inflammation (≤ 0.5+ anterior chamber cells, ≤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and ≤ 2 drops/day of topical 1% prednisolone acetate.
次要结局
- Number of Participants Achieving Treatment Success After Switching to Other Medication (Phase II, 0-6 Months)(6 Months)
- Number of Participants Achieving Treatment Success at 12 Months on Same Medication (Phase I, 6-12 Months)(12 Months)
研究者
研究点 (7)
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