Clinical Trial: Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
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 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.
Detailed Summary: 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 doctor.
Sponsor: The Cleveland Clinic
Current 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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.
Original Secondary Outcome: Same as current
Information By: The Cleveland Clinic
Dates:
Date Received: March 28, 2006
Date Started: March 2006
Date Completion:
Last Updated: May 22, 2007
Last Verified: May 2007
