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Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

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ClinicalTrials.gov Identifier: NCT00113971
Recruitment Status : Terminated
First Posted : June 13, 2005
Last Update Posted : April 3, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Lupus Erythematosus, Systemic Drug: epratuzumab Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
Study Start Date : April 2005
Primary Completion Date : March 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Pharma
Investigators
Study Director: Anna Barry UCB Pharma
More Information

Publications:
Kaufmann J, Wegener WA, Horak ID, et al. Pilot clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy in systemic lupus erythematosus (SLE) [abstract]. Ann Rheum Dis 2004; 63 (suppl I): Thu0443. (Published online at http://www.eular.org)

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00113971     History of Changes
Other Study ID Numbers: SL0002 (IMMU-103-SLE-02)
First Posted: June 13, 2005    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: March 2012

Keywords provided by UCB Pharma:
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