Study of Epratuzumab in Systemic Lupus Erythematosus

NCT ID: NCT00383513

Last Updated: 2012-07-12

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2012-01-31

Brief Summary

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Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Detailed Description

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Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Conditions

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Systemic Lupus Erythematosus

Keywords

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Lupus Antibody B-Cell Immunotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Epratuzumab

Group Type EXPERIMENTAL

Epratuzumab

Intervention Type BIOLOGICAL

360 mg/m\^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

Interventions

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Epratuzumab

360 mg/m\^2 four consecutive 12-week maintenance cycles beginning with 2 consecutive weekly administrations each lasting ≤ 1 hour

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria

* Development of toxicity to epratuzumab
* Significant protocol deviations during the SL0003 or SL0004 studies
* Evidence of significant infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Birmingham, Alabama, United States

Site Status

Tucson, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

Upland, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

Denver, Colorado, United States

Site Status

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

Site Status

Baltimore, Maryland, United States

Site Status

Durham, North Carolina, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Countries

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

Other Identifiers

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EudraCT #: 2006-004496-36

Identifier Type: -

Identifier Source: secondary_id

SL0006

Identifier Type: -

Identifier Source: org_study_id