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.
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
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)
--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