Characterization of Immunogenicity of Tumor Necrosis Factor Inhibitors in Arthritis Patients With Poorer Treatment Response Due to Gender, Obesity and Smoking Status.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Treatment response
研究概览
简要总结
The aim of the study is to explore whether the influence of gender, tobacco smoking and obesity on treatment response in tumor necrosis factor inhibitors (TNFIs) can be explained by high degree of inflammation, human leucocyte antigen (HLA) type, autoantibodies, TNF and TNFI concentration and presence of ADA.
详细描述
Tumor necrosis factor inhibitors (TNFIs) have been uses with success since 1999 in Denmark in treatment of various inflammatory diseases, eg. rheumatoid arthritis (RA), Chrohn's disease, psoriasis, psoriatic arthritis (PsA) and ankylosing spondylitis (AS).
TNFIs block a central cytokine in the inflammatory process, tumor necrosis factor (TNF).
Because the drugs are large proteins, they are prone to trigger an immune response and elicit anti-drug antibodies(ADA).
Epidemiologic studies have revealed that groups of patients (women, tobacco smokers, obese patients) with inflammatory rheumatic diseases have a lower response to TNFIs. The reasons for this are not fully elucidated. The hypothesis is that immunogenicity and changed pharmacokinetic of TNFI are causes of the inferior response.
The investigators will carry out a prospective clinical studies of 120 arthritis patients (RA, PsA and AS) initiating treatment with adalimumab or infliximab. The patients will be followed for 12 months and will be registered in DANBIO as normal praxis. Blood samples will be collected at baseline, 2, 4 and 12 months or at termination of the 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years
- •Diagnosed with RA, PsA or AS.
- •Starting treatment with infliximab or adalimumab.
- •Co- treatment with csDMARD or glucocorticoid is acceptable.
- •No new bDMARD is initiated at the time of sampling.
排除标准
- 未提供
结局指标
主要结局
Treatment response
时间窗: 12 months
Changes in disease activity score according to the diagnose. A reduction in the disease activity score indicates a good treatment response. * Disease Activity Score 28 joints with C-reactive protein (DAS28-CRP) * Disease Activity in Psoriasis Arthritis (DAPSA) * Ankylosing Spondylitis Activity Score (ASDAS) * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) * Bath Ankylosin Spondylitis Functional Index (BASFI)
次要结局
- Concentration of autoantibodies(Day 1)
- Immunogenesity(12 months)
- Drug koncentration(12 months)
- Concentration of markers of inflammation(12 months)
- HLA-type(Day 1)
研究者
Karen Buch Lauridsen
Principal Investigator
Aalborg University Hospital