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Janssen Stelara Study (Lupus) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug, ustekinumab, is safe and helps people with SLE.
What is the Condition Being Studied?
Systemic Lupus Erythematosus (SLE)

Who Can Participate in the Study?

Adults age 18-75 who:
- Have been diagnosed with SLE
- Are getting standard of care treatment for active SLE
- Do not have a history of active or inactive tuberculosis

Age Group
Adults

What is Involved?

IIf you choose to join this study, you will:
- Be randomly assigned (like drawing numbers from a hat) to one of the two groups:
-- Group 1 patients will get the study drug, ustekinumab (an intravenous (IV) infusion)
OR
--Group 2 patients will get the placebo (an inactive liquid like saltwater) IV infusion
- Have physical exams and EKGs done
- Give blood and urine samples
- Fill out surveys and questionnaires about your ability to do your
normal activities at home, your ability to work, your pain, and how your
condition is affecting your quality of life
- Have 16 study visits

Study Details

Full Title
A Multicenter. Randomized, Double blind, Placebo-controlled, Parallel-group Study of Ustekinumab in Subjects with Active Systemic Lupus Erythematosus CNTO1275SLE3001
Principal Investigator
Protocol Number
IRB: PRO00100394
NCT: NCT03517722
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698