EUCTR2014-003022-40-DE进行中（未招募）1 期
Comparison of the bacterial microbiota in the skin and gut of psoriasis patients before and after sytemic treatment with adalimumab and ustekinumab or cyclosporin - MIPSO
niversitätsklinikum Münster0 个研究点目标入组 36 人开始时间: 2014年10月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
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
- •Inclusion criteria for all patients:
- •1. Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI = 10).
- •2. > 18 years (male and female).
- •3. Treatment according to the guidelines and standard therapies for
- •psoriasis with adalimumab, ustekinumab or cyclosporine.
- •Additional inclusion criteria for patients who will receive adalimumab or ustekinumab:
- •1.Patients with moderate or severe chronic plaque psoriasis who did not respond to other systemic therapy such as ciclosporine, methotrexate, or PUVA or patients with contraindications or intolerance to such a therapy.
- •Additional inclusion criteria for patients who will receive ciclosporine:
- •1.Patients with at least moderate psoriasis vulgaris (plaque psoriasis) (PASI = 10) who are not adequately treatable with conventional systemic therapy.
- •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 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Exclusion criteria for all patients:
- •1.Patients treated with systemic immunosuppressives, adalimumab, etanercept, ustekinumab or infliximab within a period of 5 half-life periods of the respective drug before taking the initial skin swabs /biopsies.
- •2.Simultaneous therapy with systemic immunosuppressives.
- •3.Patients treated with antibiotics within at least 4 weeks before taking the initial skin swabs/biopsies or patients treated with antibiotics in the course of the trial with the exception of tuberculosis prophylaxis with Isoniazid.
- •4.Psoriasis patients who currently receive phototherapy or have received phototherapy within a period of 2 weeks before taking the initial skin swabs/biopsies.
- •5.Patients who can not interrupt the local, topical therapy with calcineurin inhibitors or vitamin D3 analogues in skin areas chosen for the skin swabs/biopsies. In skin areas chosen for the swabs/biopsies topical therapy is not allowed within 7 days before sampling.
- •6.Patients with relevant active infections (e.g. active tuberculosis or other severe infections such as sepsis and opportunistic infections).
- •7.HbsAG-positive patients. HCV-PCR-positive patients.
- •8.HIV-positive patients.
- •9.Current malignancies or history of malignancies.
- •10.Immunodeficient patients.
- •11.Patients who currently receive chemotherapy or radiotherapy or received chemotherapy or radiotherapy within the last 12 months prior to sampling of the initial skin swabs/biopsies.
- •12.Patients with uncontrolled chronic diseases which require continuous therapy, and which are not stable in the opinion of the investigator.
- •13.Patients with other chronic skin diseases such as atopic dermatitis or lupus erythematosus, which could affect the cutaneous microbiota.
- •14.Patients with psychiatric comorbidity, which causes deficient or missing ability for consent.
- •15.Participation in an another interventional trial during this trial or within 4 weeks of study entry or within 5 half-life periods of the prior investigational drug according to which period is longer.
- •16.Pregnancy or lactation. Women of childbearing potential or men with female partners of childbearing potential: Unwilling to agree to use reliable contraceptive methods (Pearl index < 1) during the trial and in addition to it at least 15 weeks after termination of therapy with Stelara® and at least 5 months after termination of therapy with Humira®.
- •17.Evidence of MRSA within 6 months before taking the initial skin swabs/biopsies.
- •18.Patients with psoriasis vulgaris exlusively located in the area of the head.
- •Additional exclusion criteria for patients who will receive adalimumab:
- •1.Allergy to adalimumab or the other excipients of Humira®.
- •2.Heart failure NYHA III° or IV°.
- •3.Preexisting or incipient demyelinating diseases of the CNS or the PNS.
- •4.Simultaneous therapy with anakinra or abatacept.
- •5.Simultaneous vaccination with life vaccines. Vaccination with life vaccines within 5 months after the end of therapy with adalimumab.
- •6. Contraindications against tuberculosis prophylaxis with Isoniazid in the respective patients.
- •Additional exclusion criteria for patients who will receive ustekinumab:
- •1.Allergy to ustekinumab or the other excipients of Stelara®. Allergy to latex.
- •2.Simultaneous vaccination with life vaccines or vaccination with life vaccines within 2 weeks of starting therapy with ustekinimab and within at least 15 weeks after the end of therapy with ustekinumab.
- •3. Contraindications against tub
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