Observational Retrospective Studies on Single Nucleotide Variants (SNPs) on the Interleukin-6 Receptor (IL6R) and Their Influence on the Response to Treatment and Safety in Patients With Specific Rheumatic Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- CRP change
研究概览
简要总结
Tocilizumab and Sarilumab are first-line biological disease-modifying anti-rheumatic drug (bDMARD) which inhibits Interleukin 6 (IL-6) pathway through blockade of its receptor on the treatment of Rheumatoid Arthritis and other rheumatic diseases as Giant Cell Arteritis, Still's disease and Idiopathic Juvenile Arthritis. At present, there is a lack of evidence to recommend the treatment of one bDMARD over another. Seeking for genetic biomarkers to predict response to treatment could be key towards a personalized treatment strategy in rheumatology.
The investigators aime to evaluate whether functional single nucleotide polymorphisms (SNPs) in the IL6R gene could predict response and/or toxicity in patients with rheumatic diseases treated with anti-IL-6 receptor drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Diagnosis of Rheumatoid Arthritis by the American College of Rheumatology (ACR) 2010 criteria or
- •Diagnosis of Giant Cell Arteritis by the International League of Associations for Rheumatology (ILAR) criteria or
- •Diagnosis of Still disease by classification criteria (Yamaguchi et al.) or
- •Diagnosis of Idiopathic Juvenile Arthritis by ACR 1990 criteria.
- •All of the previous must have been treated with anti-IL-6R monoclonal antibodies in the last 5 years
排除标准
- •<18 years at recruitment
- •Another rheumatic disease different of the ones in the inclusion criteria
结局指标
主要结局
CRP change
时间窗: 6 months
Acute phase reactant reduction in the other diseases different of RA.
Rate of adverse events
时间窗: During treatment with anti-IL6R drugs
Known adverse events during treatment with anti-IL6R drugs
DAS28-C-reactive Protein (CRP) change
时间窗: at 6 months
Activity measure for patients with Rheumatoid Arthritis (RA)
Erythrocyte sedimentation rate (ESR) change
时间窗: 6 months
Acute phase reactant reduction in the other diseases different of RA.
次要结局
未报告次要终点