Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00113971
First received: June 10, 2005
Last updated: March 30, 2012
Last verified: March 2012

June 10, 2005
March 30, 2012
April 2005
March 2007   (final data collection date for primary outcome measure)
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
Not Provided
Complete list of historical versions of study NCT00113971 on ClinicalTrials.gov Archive Site
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

The goal of this study is to evaluate how epratuzumab is processed by the body (pharmacokinetics) and whether 2 dose levels of epratuzumab are safe and effective in patients with SLE.

This study is planned to provide information on how the body processes epratuzumab and how epratuzumab affects the body when epratuzumab is given once weekly for 4 weeks in a row at one of 2 different dose levels. Additional information will be obtained related to the natural variability of disease activity in SLE patients.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lupus Erythematosus, Systemic
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
20
June 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has SLE by American College of Rheumatology revised criteria (meets >/= 4 criteria)
  • Has had SLE for at least 6 months prior to study entry
  • Has at least one elevated autoantibody level at study entry
  • Has moderately active SLE disease at study entry in any body/organ system (Full criteria not present here due to length of considerations. The protocols should be consulted regarding the complete list of entry 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
  • Prior therapy with other anti-B cell antibodies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00113971
SL0002 (IMMU-103-SLE-02)
Not Provided
UCB Pharma
UCB Pharma
Not Provided
Study Director: Anna Barry UCB Pharma
UCB Pharma
March 2012

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