Study of Epratuzumab in Systemic Lupus Erythematosus

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

May 19, 2005
November 7, 2011
June 2005
March 2007   (final data collection date for primary outcome measure)
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.
Lupus disease activity
Complete list of historical versions of study NCT00111306 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Study of Epratuzumab in Systemic Lupus Erythematosus
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: epratuzumab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
510
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Hungary,   Netherlands,   Spain,   United Kingdom
 
NCT00111306
SL0003 (IMMU-103-03), EudraCT #: 2005-000705-59
Not Provided
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: Anna Barry UCB, Inc.
UCB, Inc.
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP