2024-513371-41-00招募中2 期
UVB : Multicenter, randomized, prospective trial comparing the Efficacy and Safety of Adalimumab to that of Tocilizumab in severe uveitis of Behçet’s disease
Assistance Publique Hopitaux De Paris, Assistance Publique Hopitaux De Paris22 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 22
- 主要终点
- Efficacy will be defined by a complete remission of ocular involvement with prednisone (or prednisolone, only if prednisone is out of stock in the market) lower or equal to 5 mg/day at W16 after randomization. Complete remission of ocular inflammation will be defined as complete resolution of retinal vasculitis and/or macular edema with prednisone (or prednisolone, only if prednisone is out of stock) lower or equal to 5 mg/day at W16. In patients with bilateral uveit
研究概览
简要总结
To assess the benefit of tocilizumab comparatively to that of adalimumab in sight-threatening Behçet’s disease uveitis at week 16.
研究设计
- 分配方式
- Randomized
- 主要目的
- Uvb
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 at Inclusion
- •Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
- •Provide written, informed consent prior to the performance of any study-specific procedures
- •Diagnosis of Behçet’s disease according to the International Criteria for Behçet's Disease (ICBD) (see appendix 18.2) or history of aphtosis
- •Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis
- •Sight threatening uveitis defined according to the validated international definition as 2 lines of drop in visual acuity on a 10/10 scale, and/or retinal inflammation (macular oedema and/or retinal vasculitis).
- •Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to Inclusion with no evidence of active Tuberculosis, active infection, or malignancy
- •For female subjects of child-bearing potential (premenopausal female capable of becoming pregnant), a negative serum pregnancy test (plasmatic or urinary)
- •For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 3 and 5 months after stopping therapy for tocilizumab and adalimumab, respectively.
- •Negative TB test obtained within 12 weeks prior to inclusion. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or UVB protocol, version 5.0 of 02/04/2024 31/76 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course. The treatment should be started at the latest at inclusion
排除标准
- •Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
- •History of intestinal ulceration or diverticulitis
- •Known porphyria
- •Laboratory values assessed during Inclusion: a. Neutrophil < 1.0 x 10^3/mm3 ; b. Platelet count < 80x 10^3/mm3 ; c. ASAT or ALAT > 5 ULN
- •Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
- •Patient on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion (these drugs must be withdrawn prior to receiving the tocilizumab or adalimumab dose on Day 0).
- •Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
- •Severe renal (Glomerular filtration rates (GFR) <30ml/min) or liver insufficiency (prothrombin <50% without other causes)
- •Any live (attenuated) vaccine within 30 days prior to inclusion
- •Breastfeeding and pregnant women
- •Active tuberculosis or history of untreated tuberculosis and/or severe infection
- •Positive HIV antibody and/or positive hepatitis B surface antigen and/or positive hepatitis C RNA, results obtained within 1 month prior to inclusion
- •History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin
- •History of severe allergic or anaphylactic reactions to monoclonal antibodies
- •History of multiple sclerosis and/or demyelinating disorder
- •Hypersensitivity to the active substance or an excipient of the IMP or the auxiliary medicine
- •Active or suspected ocular infection
- •Infection oculaire active suspectée
结局指标
主要结局
Efficacy will be defined by a complete remission of ocular involvement with prednisone (or prednisolone, only if prednisone is out of stock in the market) lower or equal to 5 mg/day at W16 after randomization. Complete remission of ocular inflammation will be defined as complete resolution of retinal vasculitis and/or macular edema with prednisone (or prednisolone, only if prednisone is out of stock) lower or equal to 5 mg/day at W16. In patients with bilateral uveit
Efficacy will be defined by a complete remission of ocular involvement with prednisone (or prednisolone, only if prednisone is out of stock in the market) lower or equal to 5 mg/day at W16 after randomization. Complete remission of ocular inflammation will be defined as complete resolution of retinal vasculitis and/or macular edema with prednisone (or prednisolone, only if prednisone is out of stock) lower or equal to 5 mg/day at W16. In patients with bilateral uveit
次要结局
- Measures of corticosteroid sparing (e.g., percent meeting targets [lower than 0.1 mg/day/kg of prednisone (or prednisolone, only if prednisone is out of stock in the market)], mean dose at week 16, and cumulative dose).
- Time to response onset
- Measures of acute-phase reactants (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], at week 4, 8, 12, 16, 24, 36 and 48
- Rate and Time to occurrence of relapse or worsening while on study. (Relapse will be defined as the reappearance of clinical and/or paraclinical features of active disease or by the occurrence of new lesions or progression of preexisting lesions).
- Changes in Behcet’s Disease Current Activity Form (BDCA) at week 8, 16 and 24
- Changes in Behcet’s Syndrome Activity Score (BSAS) at week 16
- Changes in other organs involved by BD at week 4, 8, 12, 16, 24, 36 and 48
- Changes in quality of life (QOL) (SF36v2 TM Health Survey) and Behcet’s Disease Quality of Life Measure (BD-QoL) at week 16 and 24
- Safety and tolerability of treatments in BD patients as assessed by frequency and severity of adverse clinical events at week 4, 8, 12, 16, 24, 36 and 48
- Time to treatment failure (time to occurence)
- Changes in Tyndall, flare and Vitreous Haze at week 8, 16, 24, 36 and 48
- Changes in Best corrected visual acuity (SNELLEN score) at week 8, 16, 24, 36 and 48
- Changes in central retinal thickness measured with Optical Coherence Tomography (OCT) at week 8, 16, 24, 36 and 48
- Percentage of patients with central retinal thickness <300 microns at week 8, 16, 24, 36 and 48
- Percentage of patients without retinal vessel leakage on retinal angiography at week 16, and at week 24, 36 and 48, in case of retinal vasculitis
研究者
Pr Bahram BODAGHI
Scientific
Assistance Publique Hopitaux De Paris
研究点 (22)
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