Study of Epratuzumab in Systemic Lupus Erythematosus

NCT ID: NCT00382837

Last Updated: 2014-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Epratuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria

* Development of toxicity to Epratuzumab
* Significant protocol deviations from SL0003 Study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Anna Barry

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Upland, California, United States

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Farmington, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Chicago, Illinois, United States

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Baltimore, Maryland, United States

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New York, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Durham, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Gallipolis, Ohio, United States

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Tulsa, Oklahoma, United States

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Charleston, South Carolina, United States

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Dallas, Texas, United States

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Arlington, Virginia, United States

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Edmonds, Washington, United States

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Brussels, , Belgium

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Liège, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Goiânia, , Brazil

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Rio de Janeiro, , Brazil

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São Paulo, , Brazil

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Winnipeg, Manitoba, Canada

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Prague, , Czechia

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Paris, , France

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Toulouse, , France

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Erlangen, , Germany

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Heidelberg, , Germany

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Mannheim, , Germany

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München, , Germany

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Debrecen, , Hungary

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Pécs, , Hungary

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Ancona, , Italy

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Brescia, , Italy

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Amsterdam, , Netherlands

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Groningen, , Netherlands

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Leiden, , Netherlands

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Piešťany, , Slovakia

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Barcelona, , Spain

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Madrid, , Spain

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Santander, , Spain

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Seville, , Spain

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Leeds, West Yorkshire, United Kingdom

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Birmingham, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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United States Belgium Brazil Canada Czechia France Germany Hungary Italy Netherlands Slovakia Spain United Kingdom

Other Identifiers

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EudraCT# 2006-003865-15

Identifier Type: -

Identifier Source: secondary_id

SL0005

Identifier Type: -

Identifier Source: org_study_id

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