Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Survivin status
研究概览
简要总结
To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.
详细描述
In a prospective observational study the investigators aim to study the ability of modern antirheumatic treatments to suppress levels of survivin in sera. Rheumatoid arthritis patients scheduled to start new pharmacological treatment will be followed for a period of 6 months. No intervention or influence on choice of treatment will be performed, the decision of new/other medication is entirely made by the patient and their rheumatologist. The study entails addition of survivin analyse (1 vial of sera) before and after start of new treatment. Data concerning survivin levels, disease activity and other clinical parameters before and after start of new treatment will also be analysed. The patients will leave sera for survivin analyse at baseline and 3 and 6 months after start of new treatment.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients fulfilling the RA classification criteria according to the ACR/EULAR
排除标准
- •Patients at stable/unchanged anti-rheumatic treatment
- •Other serious physical or mental illness
- •Lack of knowledge in Swedish making answering the questionnaires impossible
研究组 & 干预措施
1
干预措施: abatacept (Drug)
1
干预措施: tocilizumab (Drug)
1
干预措施: tofacitinib/baricitinib (Drug)
1
干预措施: methotrexate (Drug)
1
干预措施: sulfasalazine (Drug)
结局指标
主要结局
Survivin status
时间窗: 6 months
Patients with a survivin level of over 0.45 ng/ml are considered to be survivin positive. Patients with survivin levels under 0.45 ng/ml are considered to be survivin negative A change from survivin positive to survivin negative (or vice versa) equals conversion of survivin status.
次要结局
- Disease activity (DAS28)(6 months)
- Response to treatment(6 months)