EUCTR2008-006227-31-DE进行中（未招募）1 期
Inflammatory Topoproteome of Psoriasis under Etanercept Treatment - IDEA Trial
Medical Faculty, Otto-von-Guericke-University Magdeburg0 个研究点开始时间: 2009年1月13日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •According to approved label status of Enbrel:
- •Adult patients with moderate to severe plaque psoriasis, who have failed to respond to, or who have a contraindication to, or are intolerant of other systemic therapies including cyclosporin, methotrexate and PUVA.
- •According to study protocol:
- •The patient is able to understand the study and capable to give informed consent.
- •Written informed consent.
- •Age of more than 18 years.
- •Psoriasis Area and Severity Index (PASI) of more than 10 or involvement of body surface by psoriasis for more than 10% or Dermatologic Life Quality Index (DLQI, according to Finlay and Kahn) of more than 10.
- •Exclusion of an active or latent tuberculosis by negative tuberculosis-skin/-blood-test and chest x-ray.
- •Consideration of the following wash-out-intervals before the start of study medication: i) 2 weeks for antipsoriatic topical drugs (vitamin D and analogues, tazarotene, corticosteroids, tar), ii) 4 weeks for conventional antipsoriatic systemic drugs (methotrexate, acitretin, fumarates and ciclosporin), iii) 4 weeks for UV-treatment, iv) 3 months for efalizumab, adalimumab, infliximab, and golilumab, v) 6 months for ustekinumab, and vi) 6 months for any investigational compound / drug.
- •In case of treatment with a beta-blocker, ACE-inhibitor, anti-malaria drug (resochin), interferon or lithium: stable medication with these agents for at least 4 weeks before the start of the study medication.
- •No foreseeable necessity for vaccinations during 4 weeks before the start of the study medication, during 16 weeks of study medication and during 8 weeks afterwards.
- •Willingness to keep natural / sun light exposure adequately constant und to avoid the use of artificial UV exposition (solarium).
- •Use of anticonception in female and male study participants under study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •According to approved label status of Enbrel:
- •Hypersensitivity against the active compound (i.e. etanercept) or any other compound of Enbrel or to latex of the lid of the Enbrel syringe.
- •Sepsis or risk of sepsis.
- •A treatment with Enbrel must not be initiated in patients with active infections, including chronic or localised infections.
- •According to study protocol:
- •Severe/relevant infections including infections by tuberculosis bacteria, HIV, hepatitis B or C virus.
- •Cronic or relapsing infections in the history.
- •Diseases favouring infections, e.g. severe or un-controlled diabetes mellitus.
- •Intake of immunosuppressive agents / drugs.
- •Treatment with anankinra (= Kineret) or abatacept (= Orencia) or sulfasalazin.
- •Indication for a demyelinating disease (e.g. multiple sclerosis) in the patient´s history or in the history of a family member.
- •Heart insufficiency (NYHA III/IV).
- •Malignancies of recent relevance (incl. solid tumors, malignant hematopoetic diseases, lymphoproliferative diseases, non-melanocytic skin cancer).
- •Blood dyscrasia (incl. severe anemia, leukopenia, thrombocytopenia, pancytopenia).
- •Moderate or severe alcohol hepatitis.
- •Treatment resistance to Enbrel.
- •Intolerance to biologics.
- •Autoimmune diseases coinciding with the formation of antinuclear antibodies.
- •Precedent or current medication with azathioprine or 6-mercaptopurine.
- •History of a Felty syndrome or of a splenomegaly in combination with leukocytopenia.
- •Breast feeding.
- •Up-coming need for vaccination with live vaccine.
- •Absolute criteria for premature discontinuation are:
- •- Occurence of pregnancy.
- •- Clinically significant worsening of disease - defined as an increase of PASI of > 50% as compared to the begin of study medication.
- •- Grade 3 systemic toxicity.
- •- Grade 4 adverse event or a serious adverse event thought to be related to study medication.
- •- Serious infection (grade 3) incl. sepsis syndrome with hypotension.
- •- Withdrawal of consent.
- •- Significant exposure to varicella-virus.
- •- Need for vaccination with live vaccine.
- •The treatment may be discontinued under the following conditions:
- •- Lack of subject compliance.
- •- Significant protocol deviation.
- •- Upon decision of the investigator due to serious other reasons.
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