Efficacy ans safety of subcutaneous Efalizumab in the treatment of patients with cutaneous lupus erythematosus: A mono-centre, open-label, prospective pilot study - EFALUPUS

niversitätskrankenhaus Schleswig-Holstein0 个研究点目标入组 17 人开始时间: 2008年10月16日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients of any gender aged from 18 to 65 years;
•A clinical and histological diagnosis of CLE (DLE, SCLE or SLE with DLE or SCLE lesions) who failed to response to topical corticosteroids;
•One to 5 target lesions scoring at least moderate disease” on the IGA scale;
•One to 5 target lesions with disease activity defined as having a local RCLASI sum scoring of at least 4 per lesion based on an assessment of erythema, scale/hyperkeratosis, edema/infiltration and subcutaneous nodule/plaque of the lesion;
•Willing and able to self-inject Efalizumab or has a carer (voluntary care giver) who is willing and able to perform the injections or willing and able to come weekly to the site to get the injection;
•Sexually active females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen for at least 12 weeks prior to the study, during the study and one month after the end of the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years)
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years)
•F.1.3.1 Number of subjects for this age range

•Only scarring target lesions
•SLE with major organ involvement, requiring systemic medical treatment for the SLE;
•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 tuberculosis or other severe infection diseases, including chronic or localized
•Known malignancies other than effective treated non melanoma skin cancer
•Known thrombocytemia or anemia
•Concomitant, or within six weeks prior to dosing, systemic treatment with anti-malarials and/or concomitant or within four weeks prior to dosing, systemic treatment with corticosteroids, retinoids, thalidomide, immunosuppressive or other systemic drugs for CLE and SLE
•Treatment with immunosuppressive drugs for other reasons 4 weeks prior and within the study
•Topical corticosteroids within 14 days prior to dosing
•Concomitant treatment with drugs with a known photosensitizing potential, e.g. tetracyclines, griseofulvin, thiazides, furosemide, sulfonamides or tolebutamide;
•Known hypersensitivity to RAPTIVA® or any of its components
•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.
•Vaccination within 2 weeks prior dosing or planned vaccination during the study;

发起方

niversitätskrankenhaus Schleswig-Holstein