Status:
WITHDRAWN
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Lead Sponsor:
The Cleveland Clinic
Conditions:
Discoid Lupus Erthematosus of the Scalp
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy of Raptiva (efalizumab) in the treatment of discoid lupus erythematosus (DLE). Discoid lupus erythematosus is a chronic disorder, which may lea...
Detailed Description
This is an open label study in which the subject will be given the medication Raptiva (efalizumab) and they will be taught to self-inject by the dermatology nurse or research doctor. The subject will ...
Eligibility Criteria
Inclusion
- adults with discoid lupus erythematosus with active area of disease involving at least 10% of scalp, confirmed by biopsy, bacterial and fungal culture negative.
- ability to provide written informed consent and comply with study assessments for the full duration of the study.
- adults 18 to 70 years of age.
- if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary.
- if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary.
- Platelets \>100,000
Exclusion
- subjects with known hypersensitivity to Raptiva (efalizumab) or any of its components
- pregnant or lactating women
- patients receiving immunosuppressive agents (not allowed 30 days or 5 half-live periods before Day 0, whichever is longer).
- prior enrollment in the study
- any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- participation in another simultaneous medical investigation or trial
- history of malignancy in the last 10 years.
- signs or symptoms of systemic lupus erythematosus.
- have a history of active tuberculosis or are currently undergoing treatment for tuberculosis. A purified protein derivative (PPD) test or chest x-ray will be performed at the screening visit. Patients with a positive PPD test or chest x-ray will be excluded.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00308204
Start Date
March 1 2006
End Date
August 1 2007
Last Update
February 19 2020
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195