Dose Ranging Study of Brentuximab Vedotin in Adults With Lupus
NCT ID: NCT02533570
Last Updated: 2018-06-11
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
20 participants
INTERVENTIONAL
2015-07-31
2017-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Brentuximab vedotin
4 dose groups
Brentuximab vedotin
Placebo
Matching placebo
Placebo
Interventions
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Brentuximab vedotin
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of SLE for at least 6 months prior to screening
* Active SLE as indicated by SLE Disease Activity Index (SLEDAI) ≥ 4 at screening
* Must have failed a treatment for SLE after a trial of at least 3 months
Exclusion Criteria
* Subject has had recent serious or ongoing infection, or risk for serious infection
* Subject has a history of new or recurrent malignancy within the past 5 years
* The subject is pregnant and/or breastfeeding
* The subject fulfills diagnostic criteria for another rheumatic (overlap) disease that may confound clinical assessments in the study
* The subject has urgent, severe SLE disease activity, which, in the opinion of the Investigator, warrants immediate immunosuppressive therapy and would not be appropriate for the study
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Steve Sesterhenn, MD
Role: STUDY_DIRECTOR
Seattle Genetics Medical Monitor
Locations
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University of Alabama at Birmingham - (UAB)
Birmingham, Alabama, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Advanced Medical Research, LLC
La Palma, California, United States
University of Colorado
Aurora, Colorado, United States
Clinical Research of West Florida - Corporate
Clearwater, Florida, United States
Lakes Research, LLC
Miami Lakes, Florida, United States
Arthritis Associates
Orlando, Florida, United States
McIlwain Medical Group
Tampa, Florida, United States
Henry Ford Health System
Detroit, Michigan, United States
Clayton Medical Associates, P.C.
St Louis, Missouri, United States
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Arthritis & Rheumatology Center of Oklahoma
Oklahoma City, Oklahoma, United States
Ramesh C Gupta MD
Memphis, Tennessee, United States
Tekton Research, Inc.
Austin, Texas, United States
Accurate Clinical Research
Houston, Texas, United States
Arthritis Clinic of Northern Virginia, PC
Arlington, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SGN35-022
Identifier Type: -
Identifier Source: org_study_id
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