Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Information source: The Cleveland Clinic
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Discoid Lupus Erthematosus of the Scalp.
Intervention: Raptiva (efalizumab) (Drug)
Phase: Phase 2
Sponsored by: The Cleveland Clinic
Official(s) and/or principal investigator(s):
Wilma F Bergfeld, MD, Principal Investigator, Affiliation: Cleveland Clinic
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 lead to permanent and progressive loss of hair. Lupus is a condition of
chronic inflammation cause by an autoimmune disease. Autoimmune diseases are illnesses which
occur when the body's tissues are attacked by its own immune system. The immune system is a
complex system within the body that is designed to fight infectious agents, for example,
bacteria, and other foreign invaders.
One of the mechanisms that the immune system uses to fight infections is the production of
antibodies. Patients with lupus produce abnormal antibodies in their blood that target
tissues within their own body rather than foreign infectious agents. Lupus can cause disease
of the skin, heart, lungs, kidneys, joints, and nervous system. When only the skin is
involved, the condition is called discoid lupus erythematosus (DLE).
Raptiva (efalizumab) is a humanized immunoglobulin(a protein extract from blood which fights
off infection-sometimes called "antibody"), which targets the immune cells that are activated
in inflammation. Raptiva has been approved for use in the management of psoriasis at doses
of 1mg/kg, but is not approved for the treatment of DLE.
Official title: Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: A 10% increase in visualized hair count in the target region between baseline and week 24 as determined by macrophotography and validated computer assisted dot mapping technique.
Rating of treatment benefit via use of global photographs of the vertex region assessed as an overall improvement from baseline.
Physician's global assessment (PGA) will be used to assess improvement of disease.
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 be administering 0. 7mg/kg at week one and 1mg/kg once a week
thereafter until week 24. If the subject feels uncomfortable self-administering these
injections, the subject may identify a caregiver to administer these injections for them. He
or she will be taught to administer these injections by the dermatology nurse or research
Minimum age: 18 Years.
Maximum age: 70 Years.
- 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
- 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.
Locations and Contacts
Cleveland Clinic, Cleveland, Ohio 44195, United States
Starting date: March 2006
Last updated: May 22, 2007