Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00383214
First received: September 29, 2006
Last updated: June 6, 2012
Last verified: June 2012
  Purpose

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
Intravenous
Other: Placebo
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383214

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

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov 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.:
Lupus,
antibody,
B-cell immunotherapy

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

ClinicalTrials.gov processed this record on July 29, 2014