NCT02322723撤回不适用
Real Life Evaluation of Rheumatoid Arthritis Patients in Israel Treated With HUMIRA
AbbVie0 个研究点开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Proportion of patients who reached clinical response at 6 months
研究概览
简要总结
In Israel, data is lacking regarding the long-term effectiveness of Adalimumab in outpatient real life setting. Moreover, the association between long-term effectiveness of Adalimumab and patients' functional status as well as cultural aspects of sick leaves and visits to physician's clinics has not been demonstrated in this population. This study will collect the required data in real life settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is eligible to Adalimumab treatment according to the Israeli National Health Basket and for whom a decision of initiating Adalimumab has already been taken. Patients that are naïve to Adalimumab therapy, that have been prescribed adalimumab in accordance to physician's clinical decision and according to local guidelines, up to 30 days prior to screening.
- •Patient has performed tuberculosis (TB) screening and treatment according to national guidelines for TB screening prior to anti Tumor Necrosis Factor (anti-TNF) treatment.
- •Patient has been diagnosed with Rheumatoid Arthritis (RA) and has disease duration < 3 years.
- •Patient has moderately to severely active RA defined by Disease Activity Score (DAS) (moderately (3.2 ≤ DAS ≤ 5.1) severely (DAS ≥5.1))
- •Patient is able to sign written informed consent.
- •Patient is treated with Methotrexate (MTX) alone or in combination with other Disease Modifying Antirheumatic Drugs (DMARDs)
- •Patient might have been treated with another anti-TNF inhibitor agent if discontinued due to secondary loss of efficacy or side effects.
排除标准
- •Patient with known hypersensitivity to Adalimumab, or any of its components.
- •Patients suffering from serious infection, latent TB or other conditions prohibiting the use of Adalimumab.
- •Patient had previous non-response to an anti-TNF agent.
- •Patients currently treated with other biologic therapy.
结局指标
主要结局
Proportion of patients who reached clinical response at 6 months
时间窗: At 6 months
Proportion of patients who reached Disease Activity Score (DAS)-28 of less than 2.6 or a good DAS response compared to the score on Day 0.
次要结局
- Proportion of patients who reached clinical response at 24 months(At 24 months)
- Change in patient's functional status(Up to 24 months)
- Change in frequency of sick leave episodes(Up to 24 months)
- Change in frequency of outpatient clinic visits(Up to 24 months)
研究者
相似试验
已完成
不适用
Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRAModerate-to-severe Rheumatoid ArthritisNCT01117480AbbVie (prior sponsor, Abbott)1,013
已完成
不适用
Real-World Outcome of Rheumatoid Arthritis Patients in Korea on AdalimumabRheumatoid ArthritisNCT02627924AbbVie91
已完成
不适用
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in TaiwanRheumatoid ArthritisNCT02616380AbbVie100
进行中（未招募）
1 期
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers.Whole-Body MRI in Rheumatoid Arthritis Protocol (WRAP)Reumatoid artritisMedDRA version: 12.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidEUCTR2009-014394-41-DKHvidovre Hospital
已完成
不适用
Real-World Outcome of Adalimumab on Rheumatoid Arthritis Patients in ChinaRheumatoid ArthritisNCT02668640AbbVie55