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Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

Primary Purpose

Lupus Erythematosus, Systemic

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
epratuzumab
Sponsored by
UCB Pharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia Presbyterian Medical Center
  • Lupus Center of Excellence
  • Rheumatology Associates

Outcomes

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.

Full Information

First Posted
June 10, 2005
Last Updated
March 30, 2012
Sponsor
UCB Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT00113971
Brief Title
Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
Official Title
A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Study Start Date
April 2005 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic
Keywords
study of epratuzumab in systemic lupus erythematosus, systemic lupus erythematosus, SLE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
epratuzumab
Primary Outcome Measure Information:
Title
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
Secondary Outcome Measure Information:
Title
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Barry
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Lupus Center of Excellence
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Rheumatology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background

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Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)

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