TNF-alfa Inhibitors and Antibody Production in Patients With Psoriasis
Production of Antibodies Against Tnf-alfa Blockers in Patients With Psoriasis
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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Hellerup、丹麦、2900
- 招聘中
- Copenhagen University Hospital Gentofte, Department of Skin and Allergies
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接触：
- Lone Skov, MD, PhD
- 电话号码：+4539773204
- 邮箱：lone.skov.02@regionh.dk
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接触：
- Peter Jensen, MD
- 电话号码：+4539777538
- 邮箱：peter.jensen@regionh.dk
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首席研究员：
- Lone Skov, MD, PhD
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副研究员：
- Peter Jensen, MD
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副研究员：
- Claus Zachariae, MD, PhD
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-
-
-
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Stockholm、瑞典、17177
- 招聘中
- Karolinska Institute, Department of Medicine
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接触：
- Mona Ståhle, MD, PhD
- 邮箱：mona.stahle@ki.dk
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首席研究员：
- Mona Ståhle, MD, PhD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male or female
- Age above 18
- Psoriasis
- Indication for treatment with tnf alfa blocking drug
- Written informed consent obtained
Exclusion Criteria:
- Severe psychiatric disorder
- No indication for treatment with tnf-alfa blocking drug
- Pregnancy
- Breastfeeding
- No written informed consent
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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
|
The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug. The study subjects will receive treatment with one drug only -
The consulting dermatologist decides which drug to use according to official guidelines
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in concentration of tnf-alfa antibodies in serum
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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Measurement (ELISA) of concentration of tnf-alfa neutralizing antibodies
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3, 6, and 12 months after start of tnf-alfa blocking agent
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in severity of psoriasis, PASI
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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severity of psoriasis assessed by PASI
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3, 6, and 12 months after start of tnf-alfa blocking agent
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Presence of psoriatic arthritis
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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Does the patient have psoriasis arthritis
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3, 6, and 12 months after start of tnf-alfa blocking agent
|
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change in dermatology life quality index (DLQI)
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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psoriasis severity assessed by the dermatology life quality index (DLQI)
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3, 6, and 12 months after start of tnf-alfa blocking agent
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height (cm)
大体时间：3 months
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subject´s height in centimeters
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3 months
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change in weight (kg)
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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subjects weight in kilograms
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3, 6, and 12 months after start of tnf-alfa blocking agent
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
assessment of change in concentrations of other biomarkers of interest in psoriasis
大体时间：3, 6, and 12 months after start of tnf-alfa blocking agent
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Collection of 3 ml of serum which are kept at -80 degrees celcius for later analysis of future biomarkers of interest
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3, 6, and 12 months after start of tnf-alfa blocking agent
|
合作者和调查者
调查人员
- 研究主任：Lone Skov, MD, PhD、Copenhagen University Hospital Gentofte, Department of Skin and Allergies
- 首席研究员：Mona Ståhle, MD, PhD、Karolinska Institute, Department of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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