Study Details
Testing the Drug Anifrolumab to Treat Pediatric Patients with Systemic Lupus Erythematosus
(IRB#: IRB_00167080)
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect various organs of the body, especially the skin, joints, blood, kidneys, and central nervous system. "Chronic" means that it can last for a long time. "Autoimmune" means that there is a disorder of the immune system, which, instead of protecting the body from bacteria and viruses, attacks the persons tissues. Anifrolumab is an approved drug not yet tested in pediatric patients (ages 5 to 18 years old) with SLE. This study wants to see if the drug will help pediatric patients with this condition and is safe. People in the study will receive the study drug Anifrolumab or a placebo. The placebo looks like the drug but does not have the medication. Being in the study requires attending in-person visits at the study clinic for about 2 years and 4 months. Participants will be paid for time spent in the study. Medical tests will be done during the study to track the health of participants.
- All genders
- Over 7 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 7 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 5 to 18 years old
- Diagnosis of SLE
- Auto-antibody positive so instead of protecting the body from bacteria and viruses an attack on the persons tissues occurs
- Must be receiving at least one specific treatment for SLE
- Able to attend in-person visits at the study clinic
Exclusion Criteria
- Diagnosis of a monogenic form (mutation of a single gene) SLE
- History of or current diagnosis of clinically significant non-SLE-related vasculitides (the bodys immune system attacks the blood vessels causing inflammation)
- History of suicidal thoughts and behavior
- Active severe or unstable neuropsychiatric SLE (disease affects the brain, spinal cord, or other nerves in the body)
- Any other serious disease or disorder that impacts study participation
Will I be paid for my time?
Yes
IRB#: IRB_00167080
PI: PETER CHIRASEVEENUPRAPUND
Department: PEDIATRICS
Approval Date: 2024-10-17 06:00:00
Specialties: Rheumatology
I am Interested