Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308204
Status:
WITHDRAWN
Last Update Posted:
2020-02-19
First Post:
2006-03-28
Brief Title:
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
inadequate number of enrolled study subjects
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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 immunoglobulina 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 1mgkg but is not approved for the treatment of DLE
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 immunoglobulina 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 1mgkg but is not approved for the treatment of DLE
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 be administering 07mgkg at week one and 1mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None