Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00383214
Last Updated: 2012-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
54 participants
INTERVENTIONAL
2005-05-31
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Epratuzumab in Systemic Lupus Erythematosus
NCT00111306
Study of Epratuzumab in Systemic Lupus Erythematosus
NCT00382837
Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
NCT00624351
Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE)
NCT01261793
Study of Epratuzumab in Systemic Lupus Erythematosus
NCT00383513
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Placebo
Intravenous
Placebo
Intravenous
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Epratuzumab
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
Placebo
Intravenous
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BILAG Index B Level Activity in at least 2 body systems/organs
* Has SLE by ACR revised criteria (meets,\<4 criteria)
Exclusion Criteria
* Allergy to human antibodies or Murine.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anna Barry
Role: STUDY_DIRECTOR
UCB Pharma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
Upland, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
New York, New York, United States
Plainview, New York, United States
Rochester, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Gallipolis, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Dallas, Texas, United States
Arlington, Virginia, United States
Edmonds, Washington, United States
Brussels, , Belgium
Liège, , Belgium
Rio de Janeiro, Rio de Janeiro, Brazil
Goiânia, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Sorocaba, , Brazil
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
Hradec Králové, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Paris, , France
Toulouse, , France
Erlangen, , Germany
Heidelberg, , Germany
Mannheim, , Germany
München, , Germany
Ancona, , Italy
Brescia, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Barcelona, , Spain
Madrid, , Spain
San Cristóbal de La Laguna, , Spain
Santander, , Spain
Seville, , Spain
Leeds, West Yorkshire, United Kingdom
Birmingham, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Sheffield, , United Kingdom
United Kingdom, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EudraCT #: 2005-000706-31
Identifier Type: -
Identifier Source: secondary_id
SL0004(IMMU-103-04)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.