Study of Epratuzumab in Systemic Lupus Erythematosus - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00111306

Purpose

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

Condition	Intervention	Phase
Systemic Lupus Erythematosus	Drug: epratuzumab	Phase III

MedlinePlus related topics: Lupus

Drug Information available for: Immunoglobulins Globulin, Immune Epratuzumab Yttrium Y 90 Epratuzumab

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Further study details as provided by UCB:

Primary Outcome Measures:

Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.

Secondary Outcome Measures:

Proportion of patients with complete response or partial response;
Individual BILAG assessments;
Physician and patient assessment scores;
Time-to treatment failure;
Successful steroid reduction by weeks 20 and 24;
Maintenance of steroid reduction at 24 and 48 weeks;
Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
Assess epratuzumab on Health-related quality of life.

Estimated Enrollment:	510
Study Start Date:	June 2005

Eligibility

Criteria

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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111306

Locations

United States, Alabama

Birmingham, Alabama, United States
United States, Arizona

Tucson, Arizona, United States
United States, California

Los Angeles, California, United States

Upland, California, United States
United States, Colorado

Denver, Colorado, United States
United States, District of Columbia

Washington, District of Columbia, United States
United States, Maryland

Baltimore, Maryland, United States
United States, New York

Bronx, New York, United States

New York, New York, United States
United States, North Carolina

Durham, North Carolina, United States

Winston-Salem, North Carolina, United States
United States, Oklahoma

Tulsa, Oklahoma, United States
United States, South Carolina

Charleston, South Carolina, United States
Belgium

Brussels, Belgium
Hungary

Debrecen, Hungary
Netherlands

Amsterdam, Netherlands
Spain

Santander, Spain
United Kingdom

Birmingham, United Kingdom

Sponsors and Collaborators

UCB

Investigators

Study Director:

Anna Barry

UCB

More Information

Study ID Numbers:	SL0003 (IMMU-103-03), EudraCT #: 2005-000705-59
Study First Received:	May 19, 2005
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00111306
Health Authority:	United States: Food and Drug Administration; Belgium: Ministry of Social Affairs, Public Health and the Environment; Brazil: Ministry of Health; Canada: Health Canada; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; India: Ministry of Health; Italy: The Italian Medicines Agency; Mexico: National Institute of Public Health, Health Secretariat; Netherlands: Medicines Evaluation Board (MEB); Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by UCB:

Lupus
Antibody
B-cell immunotherapy

Study placed in the following topic categories:

Antibodies
Autoimmune Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immunoglobulins

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009