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Study of Epratuzumab in Systemic Lupus Erythematosus

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00382837
First received: September 29, 2006
Last updated: May 25, 2012
Last verified: March 2007
History of Changes
  Purpose

Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments


Condition Intervention Phase
Systemic Lupus Erythematosus
 Drug: Epratuzumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems

Resource links provided by NLM:

MedlinePlus related topics: Lupus
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.

Secondary Outcome Measures:
  • To continue to assess the efficacy and tolerability of epratuzumab;
  • To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
  • To continue to assess epratuzumab on Health-related quality of life in lupus patients;
  • To continue to assess disease status as reported by the patient and physician.

Enrollment: 0
Study Start Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

  • Development of toxicity to Epratuzumab
  • Significant protocol deviations from SL0003 Study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382837

  Show 54 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Anna Barry UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00382837     History of Changes
Other Study ID Numbers: SL0005, EudraCT# 2006-003865-15
Study First Received: September 29, 2006
Last Updated: May 25, 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: Ministry of Health
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 May 16, 2013