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Trial record 1 of 1 for:    NCT00383214
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Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

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: NCT00383214
Recruitment Status : Terminated
First Posted : October 3, 2006
Last Update Posted : June 7, 2012
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Other: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 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 Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
Study Start Date : May 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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Arm Intervention/treatment
Active Comparator: Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
 Drug: Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Placebo Comparator: Placebo
Intravenous
 Other: Placebo
Intravenous


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

Inclusion Criteria:

  • +ANA at screening
  • BILAG Index B Level Activity in at least 2 body systems/organs
  • Has SLE by ACR revised criteria (meets,<4 criteria)

Exclusion Criteria:

  • Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
  • Allergy to human antibodies or Murine.
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): NCT00383214


Locations
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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: NCT00383214    
Other Study ID Numbers: SL0004(IMMU-103-04)
EudraCT #: 2005-000706-31
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
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