Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis, Compared With Adalimumab Plus High Dose Oral Glucocorticosteroid, a Non-inferior, Multi-center, Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 130
- 主要终点
- Uveitis control
研究概览
简要总结
This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg/d prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg/d prednisone or equivalent) with slow tapering.
详细描述
According to the most recent European League Against Rheumatism (EULAR) recommendation, patients presenting with an initial or recurrent episode of acute sight-threatening uveitis should be treated with high-dose glucocorticoids, infliximab or interferon-α. Adalimumab, another TNFα antagonist, is also considered as an alternative for infliximab and have proved its efficacy in several RCTs in the treatment of non-infectious intermediate, posterior and pan-uveitis. As higher dose glucocorticosteroid have greater side effects, this study aims to evaluate the non-inferior efficacy and safety of adalimumab plus medium-dose glucocorticosteroid compared with adalimumab plus high-dose glucocorticosteroid (and slow tapering) for recurrent posterior or pan-uveitis attack of Behcet's uveitis. Refractory BU is defined as relapse of posterior or panuveitis with at least 10mg daily prednisone (or equivalent). The acute attack will be controlled with adalimumab (80mg once, 40mg q2w thereafter) plus medium dose initial oral glucocorticosteroid (30mg daily prednisone or equivalent) in the "medium dose" group or plus high dose oral glucocorticosteroid (60mg daily prednisone or equivalent) in the "high dose" group with fixed tapering protocols. Patients will be followed up at 2w, 4w, 8w, and 12w after initiation of treatment. The primary endpoint is the inflammatory control rate. Secondary endpoints are BCVA, vascular leakage score on fundus fluorescein angiography (FFA), BOS 24 score and uveitis deterioration rate. The safety profiles of both groups will be also monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Behçet's disease (BD) patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis
- •The patient should be on ≥10mg/d oral prednisone or equivalent
排除标准
- •Previous treatment with TNFα inhibitors within 3 months
- •Pregnancy, breast feeding women
- •Malignancy
- •Heart failure
- •Demyelinating diseases
- •Renal impairment (creatinine > 1.5 mg/dl)
- •Depression or other psychic disorders
- •History of acute or chronic inflammatory joint or autoimmune disease
- •Patients with severe extra-ocular involvement other than oral/genital ulcer and skin involvement
- •Organ or bone marrow transplant recipient, cardiac failure > NYHA III
- •Acute liver disease with ALT or SGPT 2x above normal
- •White blood cell count < 3500/mm^3
- •Platelet count < 100000/mm^3
- •Hgb < 8.5g/dl
- •T-SPOT TB: ≥200 SFCs per 10^6 PBMC
- •Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of intermediate dose corticosteroids
- •Other severe ocular diseases or intraocular surgery within 3 months
- •Media opacity precluding a clear view of the fundus
- •Positive screen test for HBV, HCV, HIV infection or syphilis
- •Body weight <45 kg
- •Alcohol abuse or drug abuse
- •Mental impairment
- •Uncooperative attitude
研究组 & 干预措施
Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)
Patients will be given adalimumab with 30mg daily prednisone or equivalent with a fixed slow tapering plan.
干预措施: Adalimumab plus different doses of oral glucocorticosteroid (Drug)
High dose group (Adalimumab plus high dose oral glucocorticosteroid)
Patients will be given adalimumab with 60mg daily prednisone or equivalent with a fixed slow tapering plan.
干预措施: Adalimumab plus different doses of oral glucocorticosteroid (Drug)
结局指标
主要结局
Uveitis control
时间窗: 3 months
Inflammation control according to SUN criteria (two steps decrease of anterior chamber cell or vitreous haze or decreased to zero) or active retinal lesion recession with vitreous haze less than 0.5 grade
次要结局
- Best corrected visual acuity (BCVA)(3 months)
- BOS 24 score(3 months)
- Extent of vascular leakage(3 months)
- Uveitis deterioration(3 months)