Observational Study to Evaluate the Safety and Effectiveness of Cimzia in Rheumatoid Arthritis and Crohn's Disease Patients When Using a Comprehensive Program of Tuberculosis Screening and Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 199
- 试验地点
- 45
- 主要终点
- Incidence of Tuberculosis infection or reactivation during the study
研究概览
简要总结
This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.
详细描述
This is a prospective non interventional study. Patients enrolled in this study will receive Cimzia on prescription according to the instructions for use approved in Russia and within the frame of current standard clinical practices. The patient is evaluated at the Screening Visit for enrollment. A Baseline Visit is to be scheduled no more than 28 days after the Screening Visit. Subsequent evaluations are done routinely every 6 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been prescribed Cimzia
排除标准
- •Any contra-indication according to the Russian Summary of Product Characteristic
结局指标
主要结局
Incidence of Tuberculosis infection or reactivation during the study
时间窗: From Baseline to Week 156 (Visit 7)
The incidence of Tuberculosis (TB) infection or reactivation is assessed by routine TB diagnostic tests (Chest X-ray, skin test, Interferon-γ-release assays recognizing antigens representing 2 Mycobacterium tuberculosis proteins (preferably both blood and skin tests), ESAT-6 and CFP-10)
次要结局
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 26(From Baseline to Week 26 (Visit 2))
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 52(From Baseline to Week 52 (Visit 3))
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 78(From Baseline to Week 78 (Visit 4))
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 104(From Baseline to Week 104 (Visit 5))
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 130(From Baseline to Week 130 (Visit 6))
- Change from Baseline in Disease Activity Score [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) in Rheumatoid Arthritis (RA) patients at Week 156(From Baseline to Week 156 (Visit 7))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 26(From Baseline to Week 26 (Visit 2))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 52(From Baseline to Week 52 (Visit 3))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 78(From Baseline to Week 78 (Visit 4))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 104(From Baseline to Week 104 (Visit 5))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 130(From Baseline to Week 130 (Visit 6))
- Change from Baseline in Harvey Bradshaw Index (HBI) in Crohn's Disease patients (CD) at Week 156(From Baseline to Week 156 (Visit 7))
- Incidence of Adverse Events during the study(From Baseline to Week 156 (Visit 7))