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Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva

Primary Purpose

Discoid Lupus Erthematosus of the Scalp

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Raptiva
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Discoid Lupus Erthematosus of the Scalp focused on measuring discoid lupus, lupus, discoid lupus erythematosus, lupus of the scalp

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Raptiva

Arm Description

raptiva injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

clinical improvement of disease
Physician's global assessment (PGA) will be used to assess improvement of disease.

Full Information

First Posted
March 28, 2006
Last Updated
February 17, 2020
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00308204
Brief Title
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Official Title
Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
inadequate number of enrolled study subjects
Study Start Date
March 2006 (Actual)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erthematosus of the Scalp
Keywords
discoid lupus, lupus, discoid lupus erythematosus, lupus of the scalp

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Raptiva
Arm Type
Experimental
Arm Description
raptiva injection
Intervention Type
Drug
Intervention Name(s)
Raptiva
Other Intervention Name(s)
efalizumab
Intervention Description
injection
Primary Outcome Measure Information:
Title
Efficacy in growing scalp hair
Description
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.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
clinical improvement of disease
Description
Physician's global assessment (PGA) will be used to assess improvement of disease.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilma F Bergfeld, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Discoid Lupus Erythematosus of the Scalp and a Trial of Biologic Therapy With Raptiva

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