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Trial record 1 of 1 for:    NCT00111306
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Study of Epratuzumab in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00111306
Recruitment Status : Terminated
First Posted : May 20, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Description
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Brief Summary:
The purpose of the study is to evaluate the safety & efficacy of Epratuzumab with standard treatments for patients with SLE.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: epratuzumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : June 2005
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111306


Locations
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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 Pharma
Investigators
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Study Director: Anna Barry UCB Pharma
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00111306    
Other Study ID Numbers: SL0003 (IMMU-103-03)
EudraCT #: 2005-000705-59
First Posted: May 20, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011
Keywords provided by UCB Pharma:
Lupus
Antibody
B-cell immunotherapy
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents