Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

This study has been terminated.
Information provided by (Responsible Party):
UCB, Inc. Identifier:
First received: September 29, 2006
Last updated: June 6, 2012
Last verified: June 2012

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

Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: Epratuzumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

Further study details as provided by UCB, Inc.:

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

Enrollment: 54
Study Start Date: May 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT00383214

  Show 60 Study Locations
Sponsors and Collaborators
UCB, Inc.
Study Director: Anna Barry UCB, Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc. Identifier: NCT00383214     History of Changes
Other Study ID Numbers: SL0004(IMMU-103-04), EudraCT #: 2005-000706-31
Study First Received: September 29, 2006
Last Updated: June 6, 2012
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Brazil: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Ministry of Health
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
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
United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
B-cell immunotherapy

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 17, 2014