Monoclonal Antibody Treatment for Systemic Lupus Erythematosus
Status:
Completed
Trial end date:
2017-09-07
Target enrollment:
Participant gender:
Summary
This study will examine the safety and effects of the monoclonal antibody MRA in patients
with systemic lupus erythematosus (SLE). Antibodies normally fight invading organisms. In
autoimmune diseases, such as lupus, however, antibodies attack the body s own tissues. MRA is
an antibody manufactured in the laboratory that blocks the action of interleukin-6 (IL-6), a
substance that increases antibody production and is involved in inflammation that may cause
organ damage in SLE.
Patients 18 years of age and older with moderately active systemic lupus erythematosus may be
eligible for this 6-month study. Candidates will be screened with blood and urine tests,
chest X-ray, electrocardiogram (EKG), and screening tests for certain cancers.
Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the
clinic. The MRA is infused over a period of about 1 hour through a catheter (thin plastic
tube) inserted into an arm vein. Patients will be observed for 1 to 2 hours after each
infusion for drug side effects. For the first and last infusions, patients will return to the
clinic for blood tests 24 to 48 hours after the infusion. Additional tests may be done if
medically indicated.
Three different doses of MRA will be used in three groups of patients. The first group (4
patients) will receive the lowest dose. If this dose is well tolerated, a second group (6
patients) will receive a higher dose. If this dose is also well tolerated, a third group (6
patients) will receive the highest study dose.
Patients will be evaluated at various intervals for up to 3 months after the last dose of
MRA. The follow-up visits will include a review of the patient s medical history, a physical
examination, blood and urine tests, and an EKG.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)