EUCTR2008-003833-25-DEActive, not recruitingNot Applicable
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 sites17 target enrollmentStarted: October 16, 2008Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 17
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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;
Investigators
Similar Trials
Completed
Not Applicable
Feasibility, safety and efficacy of Subcutaneous Electrical Nerve Stimulation (SENS) in patients with chronic refractory angina pectoris. A pilot study.angina pectorisNL-OMON33732niversitair Medisch Centrum Groningen10
Unknown
Phase 3
Efficacy and Safety of Subcutaneous Secukinumab for Moderate to Severe Chronic Plaque-type Psoriasis for up to 1 Year (ERASURE)psoriasisJPRN-jRCT2080221490ovartis Pharma K.K.
Completed
Not Applicable
Safety and efficacy of subcutaneous tocilizumab for patients with systemic-onset juvenile idiopathic arthritisSystemic-onset juvenile idiopathic arthritis(sJIA)JPRN-UMIN000023036Department of Pediatrics, Yokohama City University5
Not yet recruiting
Phase 4
Safety and efficacy of efalizumab in combination with methotrexate in patients with severe psoriasis: a comparative study.Psoriasis10014982NL-OMON31349niversitair Medisch Centrum Sint Radboud30
Active, not recruiting
Phase 1
Safety and efficacy of efalizumab in combination with methotrexate in patients with severe psoriasis: a comparative study.Moderate to severe chronic plaque psoriasisMedDRA version: 9.1Level: LLTClassification code 10050576Term: Psoriasis vulgarisEUCTR2007-001630-14-NLniversity Medical Centre St. Radboud, Department of Dermatology30
