Pharmacokinetics Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
A Randomized Phase II Pharmacokinetics/Pharmacodynamics Study of Epratuzumab in Patients With Systemic Lupus Erythematosus
1 other identifier
interventional
20
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2005
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 10, 2005
CompletedFirst Posted
Study publicly available on registry
June 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedApril 3, 2012
March 1, 2012
1.9 years
June 10, 2005
March 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of pharmacokinetic samples for epratuzumab levels and evaluation of adverse events, infusion reactions and other safety parameters.
Secondary Outcomes (1)
Evaluation of pharmacokinetic samples to assess immunogenicity and evaluation of post-treatment BILAG scores for initial efficacy and disease variability.
Interventions
Eligibility Criteria
You may qualify if:
- 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.)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (3)
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15261, United States
Rheumatology Associates
Charleston, South Carolina, 29407, United States
Related Publications (1)
Dorner T, Kaufmann J, Wegener WA, Teoh N, Goldenberg DM, Burmester GR. Initial clinical trial of epratuzumab (humanized anti-CD22 antibody) for immunotherapy of systemic lupus erythematosus. Arthritis Res Ther. 2006;8(3):R74. doi: 10.1186/ar1942. Epub 2006 Apr 21.
PMID: 16630358BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anna Barry
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2005
First Posted
June 13, 2005
Study Start
April 1, 2005
Primary Completion
March 1, 2007
Study Completion
June 1, 2007
Last Updated
April 3, 2012
Record last verified: 2012-03