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

• Conditions: Cutaneous lupus erythematosus (discoid LE or subacute cutaneous LE) or systemic lupus erythematosus with cutaneous DLE or SCLE lesions without major organ involvment.; MedDRA version: 9.1Level: LLTClassification code 10013071Term: Discoid lupus erythematosis; MedDRA version: 9.1Level: LLTClassification code 10057903Term: Subacute cutaneous lupus erythematosus; MedDRA version: 9.1Level: LLTClassification code 10056509Term: Cutaneous lupus erythematosus

• Registration Number: EUCTR2008-003833-25-DE
• Lead Sponsor: niversitätskrankenhaus Schleswig-Holstein

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

•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

Exclusion Criteria

•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;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified