Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change in concentration of tnf-alfa antibodies in serum
研究概览
简要总结
TNF alfa blockers are widely used for treatment of severe psoriasis. These biologics are well-tolerated with few side effects.
Unfortunately not all patients respond adequately to treatment with tnf alfa blockers. Some do not respond at all while others respond initially but gradually lose effect despite increased dose and more frequent administration.
The cause of treatment failure is largely unknown and it may be production of tnf-alfa neutralizing antibodies. This has been demonstrated in patients with rheumatoid arthritis and inflammatory bowel disease who lost response after treatment with tnf-alfa blockers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age above 18
- •Psoriasis
- •Indication for treatment with tnf alfa blocking drug
- •Written informed consent obtained
排除标准
- •Severe psychiatric disorder
- •No indication for treatment with tnf-alfa blocking drug
- •Pregnancy
- •Breastfeeding
- •No written informed consent
研究组 & 干预措施
tnf-alfa treatment (infliximab, adalimumab, or etanercept)
This arm includes all the patients of the study. They are patients who are start treatment with a tnf-alfa blocking drug
干预措施: subjects will receive either infliximab, adalimumab or etanercept (Drug)
结局指标
主要结局
change in concentration of tnf-alfa antibodies in serum
时间窗: 3, 6, and 12 months after start of tnf-alfa blocking agent
Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies
次要结局
- change in dermatology life quality index (DLQI)(3, 6, and 12 months after start of tnf-alfa blocking agent)
- height (cm)(3 months)
- change in weight (kg)(3, 6, and 12 months after start of tnf-alfa blocking agent)
- change in severity of psoriasis, PASI(3, 6, and 12 months after start of tnf-alfa blocking agent)
- Presence of psoriatic arthritis(3, 6, and 12 months after start of tnf-alfa blocking agent)
研究者
Peter Jensen
MD
University Hospital, Gentofte, Copenhagen