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Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

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

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 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
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

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
Other: Placebo

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

Information from the National Library of Medicine

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

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.

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

  Show 60 Study Locations
Sponsors and Collaborators
UCB Pharma
Study Director: Anna Barry UCB Pharma

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00383214     History of Changes
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:
B-cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases