Study of Epratuzumab in Systemic Lupus Erythematosus

NCT ID: NCT00111306

Last Updated: 2011-11-08

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-03-31

Brief Summary

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The purpose of the study is to evaluate the safety \& efficacy of Epratuzumab with standard treatments for patients with SLE.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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epratuzumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has SLE by ACR revised criteria (meets \<4 criteria);
* Has SLE with at least one elevated lupus antibody;
* Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion Criteria

* Active severe CNS or Renal disease defined by BILAG as Level A
* Allergy to murine or human antibodies
* Antiphospholid antibodies AND a history of thrombocytopenic events
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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Anna Barry

Role: STUDY_DIRECTOR

UCB Pharma

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

Denver, Colorado, United States

Site Status

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

Site Status

Baltimore, Maryland, United States

Site Status

New York, New York, United States

Site Status

The Bronx, New York, United States

Site Status

Durham, North Carolina, United States

Site Status

Winston-Salem, North Carolina, United States

Site Status

Tulsa, Oklahoma, United States

Site Status

Charleston, South Carolina, United States

Site Status

Brussels, , Belgium

Site Status

Debrecen, , Hungary

Site Status

Amsterdam, , Netherlands

Site Status

Santander, , Spain

Site Status

Birmingham, , United Kingdom

Site Status

Countries

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United States Belgium Hungary Netherlands Spain United Kingdom

References

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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Reference Type DERIVED
PMID: 33687069 (View on PubMed)

Other Identifiers

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EudraCT #: 2005-000705-59

Identifier Type: -

Identifier Source: secondary_id

SL0003 (IMMU-103-03)

Identifier Type: -

Identifier Source: org_study_id