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Study of Epratuzumab in Systemic Lupus Erythematosus

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00111306
First received: May 19, 2005
Last updated: November 7, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Systemic Lupus Erythematosus
Drug: epratuzumab
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 Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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.

Estimated Enrollment: 510
Study Start Date: June 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Has SLE by ACR revised criteria (meets <4 criteria);
  • Has SLE with at least one elevated lupus antibody;
  • Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic

Exclusion Criteria:

  • Active severe CNS or Renal disease defined by BILAG as Level A
  • Allergy to murine or human antibodies
  • Antiphospholid antibodies AND a history of thrombocytopenic events
  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: NCT00111306

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Upland, California, United States
United States, Colorado
Denver, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Maryland
Baltimore, Maryland, United States
United States, New York
Bronx, New York, United States
New York, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Oklahoma
Tulsa, Oklahoma, United States
United States, South Carolina
Charleston, South Carolina, United States
Belgium
Brussels, Belgium
Hungary
Debrecen, Hungary
Netherlands
Amsterdam, Netherlands
Spain
Santander, Spain
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: Anna Barry UCB Pharma
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00111306     History of Changes
Other Study ID Numbers: SL0003 (IMMU-103-03), EudraCT #: 2005-000705-59
Study First Received: May 19, 2005
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration
Belgium: Ministry of Social Affairs, Public Health and the 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: National Institute of Public Health, Health Secretariat
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

Keywords provided by UCB Pharma:
Lupus
Antibody
B-cell immunotherapy

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

ClinicalTrials.gov processed this record on November 24, 2014