Discoid Lupus Erthematosus of the Scalp Clinical Trial
Official title:
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
| NCT number | NCT00308204 |
| Other study ID # | ACD3433s |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2006 |
| Est. completion date | August 2007 |
| Verified date | February 2020 |
| Source | The Cleveland Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | August 2007 |
| Est. primary completion date | August 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic | Cleveland | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| The Cleveland Clinic |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy in growing scalp hair | 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. | 36 weeks | |
| Secondary | clinical improvement of disease | Physician's global assessment (PGA) will be used to assess improvement of disease. | 36 weeks |