Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 439
- 试验地点
- 10
- 主要终点
- Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
研究概览
简要总结
BINAR is an open and multicentric Tunisian national registry performed by nearly 100 rheumatologists
详细描述
BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical study performed in rheumatology consultations, of both public and liberal sectors. Eligible patients are recruited by successive inclusions until the end of the recruitment period, set at one year. A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project and a Data Review Committee supervises the management of the data and carries out all the missions of audit and control of validity of the collected data, as well as the planning of statistical analysis.
Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).
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
- •Age ≥ 18 years
- •Patient followed for rheumatoid arthritis according to ACR EULAR criteria or spondylitis including all disorders (axial, peripheral, enthesitis).
- •Patient on biological treatment at the time of inclusion
- •First biological treatment initiated ≤ 2 years
- •Informed consent, read and signed
排除标准
- •Evolutionary neoplasia at the time of inclusion
- •Other associated systemic diseases, except Sjögren's Syndrome
- •Consent not obtained
- •Pregnant or lactating woman
结局指标
主要结局
Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
时间窗: Up to two years of follow-up
Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\] : occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
次要结局
- Assessment of Rheumatoid Arthritis Activity(At baseline and at two years follow-up)
- Assessment of Spondylitis Disease Activity(At baseline and at two years follow-up)
- Assessment of Spondylitis Fonctional Activity(At baseline and at two years follow-up)
- Assessment of Spondylitis Activity(At baseline and at two years follow-up)
- Health Assessment Questionnaire(At baseline)