EUCTR2010-023645-29-DE进行中（未招募）不适用
Efficacy and safety of fumaric acid esters in the treatment of patients with cutaneous lupus erythematosus: A monocentre, open-label, prospective pilot study - FumaCLE
niversitätsklinikum Münster0 个研究点目标入组 11 人开始时间: 2011年1月11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
- 入组人数
- 11
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
- •-Patients of any gender aged from 18 to 70 years;
- •-A clinical and histological diagnosis of CLE (DLE, SCLE, LET, without major systemic involvement) who failed to response to topical corticosteroids;
- •-Total RCLASI activity score of >6 (at least 3 points in at least 2 locations) on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion (mucous membrane lesions/alopecia excluded);
- •-Women of childbearing potential must agree to use at least one primary method of contraception and, at the same time, a secondary method of contraception from the time of screening, throughout trial treatment, and for at least one month after finishing treatment.
- •-Signed informed consent.
- •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
- •-Patients unable to comply with the requirements of the study;
- •-Only scarred cutaneous target lesions without activity;
- •-Systemic Lupus Erythematosus (SLE) with major systemic organ involvement, e.g. clinical significant renal involvement, requiring systemic medical treatment for the disease;
- •-Active skin disease other than CLE or another progressive or serious disease that interferes with the study outcome;
- •-Symptoms of a clinically significant illness that may influence the outcome of the study in the four weeks before and during the study;
- •-Active severe infection diseases, including chronic or localized;
- •-Known malignancies in the last 5 years, other than effective treated non melanoma skin cancer;
- •-Severe liver- or kidney- disease;
- •-Severe gastrointestinal disease, like gastric or duodenal ulcer;
- •-Severe hematologic disorders;
- •-Patients with leucopenia (<3.000/mm3);
- •- Patients with lymphopenia (<500/mm3);
- •-Patients with known hypersensitivity to fumaric acid esters or their derivatives, or to any study medication components;
- •-Topical corticosteroids within 14 days prior to dosing;
- •-Local treatment with fumaric acid derivates;
- •-Initiation or change in the dose of any current systemic medication for the treatment of CLE/SLE prior to the study (time depending on drug class);
- •-Treatment with immunosuppressive drugs for other reasons, 4 weeks prior and within the study;
- •-Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolebutamide;
- •-Drugs associated to CLE-induction: terbinafine, hydrochlorothiazide, diltiazem, verapamil, nifedipine, nitrendipine, fluorouracil, penicillamine, infliximab, adalimumab, etanercept, pantoprazole;
- •-Drugs interfering/ interacting with fumaric acid esters;
- •-Drugs with nephrotoxic potential, e.g. retinoids, psoralens, methotrexate, cyclosporine, immunosuppressants, cytostatics;
- •-Participation in another clinical trial including the four week period preceding the study or having received a non-licensed drug within the last 3 months prior to the study;
- •-Pregnancy (according to pregnancy test) or nursing;
研究者
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