Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00308204
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00308204
Study Brief:
Protocol Section:
NCT00308204