EUCTR2010-018517-29-DE进行中（未招募）1 期
Topoproteome-Analysis of Psoriasis under Fumarate-Treatment. - ToPoF Clinical Trial
Medical Faculty, Otto-von-Guericke-University Magdeburg0 个研究点目标入组 15 人开始时间: 2010年1月26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
- 15
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 Fumaderm initial / Fumaderm:
- •Adult patients with moderate to severe plaque psoriasis in so far as solely topical treatment is not sufficient.
- •- No pre-treatment with Fumaderm initial / Fumaderm in the patient´s history.
- •- The patient is able to understand the study, capable to give informed consent and available for the 20 weeks of the trial.
- •- 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
- •dermatology life quality index (DLQI, according to Finlay & Kahn) of more than 10.
- •- 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 (cyclosporine, methotrexate, acitretin),
- •iii) 4 weeks for uv-treatment inclusive balneo-photo-therapy,
- •iv) 3 months for infliximab, adalimumab, golimumab, etanercept, and efalizumab,
- •v) 6 months for ustekinumab, and
- •vi) 6 months for any investigational compound / drug or any investigational treatment.
- •- Willingness of the study participant, that during the study treatment none of the under i) to vi) aforementioned treatments will be applied.
- •- 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 vaccination with a live-vaccine during 4 weeks before the start of the study medication, during 16 weeks of study medication and during 12 weeks afterwards.
- •- Willingness to keep natural sun light exposure adequately constant and to avoid the use of artificial uv exposure (solarium).
- •- Use of anticonception in female study participants of child bearing potential under study medication. Recommendation of a highly effective method of birth control (i.e. with a failure rate of less than 1% per year).
- •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 Fumaderm initial / Fumaderm.
- •- Known hypersensitivity towards the active compounds, i.e. dimethylfumarate, ethylhydrogenfumarate calcium-, magnesium- or zinc-salt, or to any other constituent of Fumaderm® initial / Fumaderm®.
- •- Severe gastrointestinal diseases, alike Ulcus ventriculi and Ulcus duodeni.
- •- Severe liver and kidney diseases.
- •- Hematologic diseases.
- •- Medium-severe to severe heart insufficiency (NYHA III/IV).
- •- Indication for a demyelinating disease (e.g. multiple sclerosis) in the patient`s history or in the history of a family member.
- •- Minimal psoriasis, alike localized plaque psoriasis or chronic stationary plaque psoriasis with an extent of less than 10% of body surface.
- •- Psoriasis of the pustular subtype.
- •- Persons under the age of 18 years.
- •- Pregnancy.
- •- Breast feeding.
- •- Relevant pathologic laboratory findings for blood cell count, liver- and kidney- parameters as well as urine status.
- •- On-going systemic treatment with methotrexate, retinoid, psoralen, cyclosporine, immunosuppressive drugs/agents, cytostatics and drugs with known nephrotoxicity.
- •- On-going topical treatment with fumaric acid derivatives, e.g. as ointments and/or bath preparations.
- •- HIV-infection.
- •- Hepatitis B oder C in the patient`s history.
- •- Malignancy of recent relevance.
- •- Serious other reason out of the investigator`s judgement.
- •Criteria for premature discontuinuation are:
- •According to label in case of:
- •- Substantial decrease of blood leukocyte count (especially with counts below 3000/µl) or other blood cell alterations.
- •- Increase of creatinin.
- •- Relevant disturbances of kidney and liver function.
- •According to an expert consensus conference [P. Altmeyer, E. Christophers et al.: Leitlinien zur Therapie mit Fumarsäureestern] dose reduction or complete stop of treatment is necessary under the following circumstances:
- •i) increase of serum creatinin for more than 30% of the level before treatment,
- •ii) proteinuria,
- •iii) decrease of leucocytes below 3.000/µl,
- •iv) decrease of lymphocytes below 500/µl and
- •v) persistant eosinophilia of more than 25 %.
- •Other absolute indications for an early termination of study medication are:
- •- Subjective and/or objective non-tolerable gastrointestinal reactions and flush-reactions.
- •- Substantial clinical worsening of psoriasis, defined as a PASI-increase by 50% as compared to the level before study treatment.
- •- Grade 3 system toxicity.
- •- Grade 4 adverse event (AE) or serious adverse event (SAE) due to study medication.
- •- Severe Infection (grade 3) including sepsis.
- •- Occurence of pregnancy.
- •- Need for vaccination with a live-vaccine.
- •- Withdrawal of consent.
- •The treatment may be discontinued under the following conditions:
- •- Lack of subject compliance.
- •- Significant protocol deviation.
- •- Upon decision of the investigator due to other serious reasons.
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