Prospective Analysis of Patients on Adalimumab for Non Infective Uveitis in Adults A 3 Year Follow Up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2. Sub-group analysis of various parameters.
研究概览
简要总结
Primary Objectives:
- Efficacy and Safety: Evaluate the effectiveness and safety of adalimumab. This will be assessed through:
a) Improvement in visual acuity (BCVA)
b) Reduction in disease activity using standardized criteria
c) Changes in clinical parameters (anterior chamber flare and cells, vitreous opacity, fundus findings)
Secondary Objectives:
- Subgroup Analysis: Analyze treatment outcomes based on demographic factors (age, gender) and specific disease characteristics (e.g., uveitis subtype, rheumatological disease subtypes).
Long-term Outcomes: Assess the durability of treatment effects and optimize follow-up visit frequency based on disease activity and treatment response.
Statement of Study Hypothesis:
Data collection and analysis of Indian patients receiving Adalimumab for uveitis. This therapy is being used in the developed world for a long time now. However, due to cost constraints it was not used much in India and at AIIMS, New Delhi. Now, with availability of biosimilars and some funding from an NGO we have started using this for patients at AIIMS. This study is an attempt to systematically keep data of such patients for assessing the effectivity and side effect profile in our patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years
- •Diagnosed with NIU requiring systemic treatment
- •Sight threatening uveitis cases which are started on Adalimumab therapy such as cases of chronic intermediate uveitis, choroiditis, vasculitis, or VKH will be predominantly included.
- •Both chronic and recurrent cases of above subtypes of uveitis on Adalimumab will be included.
- •Definitions of chronic and recurrent is as per standardized uveitis nomenclature (International).
- •Unable to maintain remission on 5mg or less prednisolone with or without other immunomodulators
- •Willingness to receive adalimumab therapy and participate in the study.
排除标准
- •Possible to maintain remission on prednisolone 5 mg or less
- •Possible to maintain remission on immunomodulators with or without prednisolone in a dose of 5mg or less
- •Active or uncontrolled systemic infection
- •Active tuberculosis
- •Uncontrolled or significant medical conditions (e.g., severe cardiovascular disease, uncontrolled diabetes, active malignancy)
- •Pregnancy or breastfeeding
- •Multiple sclerosis or other demyelinating diseases
- •Inability or unwillingness to provide informed consent.
结局指标
主要结局
2. Sub-group analysis of various parameters.
时间窗: 1. Participant recruitment: 6 months | 2. Intervention and follow-up: 3 years | 3. Data analysis and reporting: 6 months | 3. Long-term outcomes of Adalimumab treatment
1. Efficacy & Safety of Adalimumab in NIU.
时间窗: 1. Participant recruitment: 6 months | 2. Intervention and follow-up: 3 years | 3. Data analysis and reporting: 6 months | 3. Long-term outcomes of Adalimumab treatment
3. Long-term outcomes of Adalimumab treatment
时间窗: 1. Participant recruitment: 6 months | 2. Intervention and follow-up: 3 years | 3. Data analysis and reporting: 6 months | 3. Long-term outcomes of Adalimumab treatment
次要结局
- 1.Visual Acuity Improvement(2.Reduction in Retinal Thickness)
研究者
SANJAY KUMAR MISHRA
Dr RP Centre for Ophthalmic Sciences All India Institute of Medical Sciences (AIIMS) Ansari Nagar, New Delhi 110029