Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

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

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.


Condition Intervention Phase
Lupus Erythematosus, Systemic
Drug: epratuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.

Secondary Outcome Measures:
  • Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

Estimated Enrollment: 20
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

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

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
  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: NCT00113971

Locations
United States, New York
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
United States, Pennsylvania
Lupus Center of Excellence
Pittsburgh, Pennsylvania, United States, 15261
United States, South Carolina
Rheumatology Associates
Charleston, South Carolina, United States, 29407
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Anna Barry UCB, Inc.
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00113971     History of Changes
Other Study ID Numbers: SL0002 (IMMU-103-SLE-02)
Study First Received: June 10, 2005
Last Updated: March 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by UCB, Inc.:
study of epratuzumab in systemic lupus erythematosus
systemic lupus erythematosus
SLE

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

ClinicalTrials.gov processed this record on July 28, 2014