EUCTR2010-023901-36-DE进行中（未招募）不适用
Psoriasis-topoproteome under ustekinumab treatment (PIROUETTE-Study)- as an interventional observation study (phase IV) within approved label and indication and with minimal invasive taking of skin biopsies- as an investigator originated proposal (IOP) / investigator initiated study/trial (IIS/T)according to AMG and GCP regulations - PIROUETTE-Study
Faculty of Medicine, Otto-von-Guericke-University, Magdeburg0 个研究点开始时间: 2011年1月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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 STELARA™: adult patients (i.e. age of more than 18 years) 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 ciclosporin, methotrexate or PUVA.
- •No pre-treatment with STELARA™ in the patient´s history.
- •The patient is able to understand the study and capable to give informed consent.
- •Written informed consent.
- •Psoriasis area and severity index (PASI) of more than 10, or
- •involvement of body surface by psoriasis for more than 10 %, or
- •DLQI (dermatology life quality index, according to Finlay & Kahn) of more than 10.
- •Exclusion of an active or latent tuberculosis by negative tuberculosis-skin-test (negative Tbc Elispot blood test, respectively) and chest x-ray (not older than 6 months).
- •Consideration of the following wash-out-intervals before the start of study medication:
- •i) 2 weeks for antipsoriatic topical drugs (vitamin D and analogues, dithranol, corticosteroids, tar, tazarotene),
- •ii) 4 weeks for conventional antipsoriatic systemic drugs (ciclosporin, methotrexate, fumarates, acitretin),
- •iii) 4 weeks for uv-treatment,
- •iv) 3 months for etanercept, infliximab, adalimumab, and golimumab,
- •v) 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 12 weeks before the beginning of the study medication.
- •No foreseeable necessity for vaccination with a live-vaccine during 4 weeks before the beginning of the study medication, during 28 weeks of study and during 12 weeks afterwards.
- •Willingness to keep natural sun light exposure adequately constant and to avoid the use of artificial uv exposition (solarium).
- •Use of anticonception in female study participants under study medication up to 15 weeks after the last injection.
- •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 STELARA™:
- •- Hypersensitivity against the active compound (i.e. ustekinumab) or any other compound of STELARA™.
- •- Clinical relevant active infections.
- •- Malignancies of recent relevance.
- •- Intake of immunosuppressive agents / drugs.
- •- Vaccination with live-vaccines.
- •- Pregnancy.
- •- Breast feeding.
- •Absolute criteria for premature discontinuation of study medication:
- •- Clinically significant worsening of disease, defined as an increase of PASI > 25% as compared to the beginning 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.
- •- Need for vaccination with live-vaccine.
- •- Occurrence of pregnancy.
- •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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