NCT00308204

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.4 years

First QC Date

March 28, 2006

Last Update Submit

February 17, 2020

Conditions

Discoid Lupus Erthematosus of the Scalp

Keywords

discoid lupuslupusdiscoid lupus erythematosuslupus of the scalp

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • clinical improvement of disease

    36 weeks

Study Arms (1)

Raptiva

EXPERIMENTAL

raptiva injection

Drug: Raptiva

Interventions

RaptivaDRUG

injection

Also known as: efalizumab
Raptiva

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

efalizumab

Condition Hierarchy (Ancestors)

Lupus Erythematosus, CutaneousConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Wilma F Bergfeld, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff

Study Record Dates

First Submitted

March 28, 2006

First Posted

March 29, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)