Institutional Review Board, Hospital for Special Surgery
March 18, 2016
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
Alana B. Levine, MD
This trial will be conducted as a randomized open label multicenter study in individuals with active lupus nephritis age 18 and older. There will be two treatment groups of a total of 40 participants.
The study treatment will include rituximab, cyclophosphamide (CTX), and Solumedrol. This treatment will be followed by prednisone and belimumab in one group, and by prednisone without belimumab in the other group.
The total study duration will be 200 weeks. The enrollment period for this study will be 104 weeks. Study participation period will be 96 weeks, which includes a treatment phase of 48 weeks and an assessment phase of 48 weeks.
●Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria.
● Positive antinuclear antibody (ANA) or positive anti-ds DNA test results at the screening visit.
● Age 18 years or older.
● Active lupus nephritis.
● Urine Protein-Creatinine ratio >1 at study entry based on a 24-hour collection.
● Ability to provide informed consent.
●Anyone who has newly diagnosed lupus nephritis
●Anyone who has low neutrophil (a type of white blood cell) levels
●Anyone who has a low platelet (cells that help stop bleeding) count
●Anyone who has severe anemia (lack of red blood cells)
●Anyone who has very low gammaglobulin (a type of protein important to the immune system) levels
●Anyone who has infection in the lungs called tuberculosis that was not treated
●Anyone who has any active infections or has had a severe infection within the last 60 days
●Anyone who has chronic infection that is currently being treated with antibiotics
●Anyone who has received a live vaccine (a vaccine with a weakened version of a living microbe) within 3 months of study enrollment
●Anyone who has end-stage renal disease
●Anyone who has certain types of cancer in the past
● Anyone who has ever had a transplant
● Anyone who has a primary immunodeficiency (an immune system defect that is often genetic) in the past
● Anyone who is pregnant, planning to become pregnant while in the study, or breastfeeding
● Anyone who is unwilling to use an approved form of birth control (including but not limited to a diaphragm, an intrauterine device, progesterone implants or injections, oral contraceptives, the double- barrier method, or a condom)
● Anyone who has received cyclophosphamide within the past 6 months.
●Anyone who has used anti-TNF medication within the last 90 days (e.g. remicade ®, Enbrel®, humira ®, cimiza ®, simponi ®)
●Anyone who has used biologic drug (a drug that has been made from biological sources) within the last 90 days
●Anyone who has used non- biologic experimental therapeutic agents within a certain time frame
●Anyone who has received an experimental biologic agent within the past 12 months
●Anyone who has used immunoglobulin (also known as IVIG; this is a process where blood product is administered in the vein), plasmapheresis (a process where the plasma layer of blood is removed, treated, and returned to the body), or leukopheresis (a process where white blood cells are separated from blood) within the past 90 days
● Anyone who has received a biologic B cell therapy (therapies that target the B cells, which are a type of immune cell), including rituximab, belimumab, and atacicept
● Anyone who has an abnormal liver function test
● Anyone who has a serious condition that, in the investigator’s opinion, would put them at risk if they join this study
● Anyone who has a disease other than lupus that requires corticosteroids (corticosteroids are a class of chemicals that include steroid hormones)
● Anyone who has a current substance abuse or history of substance abuse within the past year
● Anyone who has had a severe allergic reaction to chimeric (not fully human) or fully human monoclonal antibodies (identical antibodies that are made by identical immune cells)
● Anyone who has had a severe allergic reaction to certain contrast agents
● Anyone who has poor vein access
● Anyone who has a history of severe depression or a severe mental condition
● Anyone who has a history of suicidal thoughts within the past 2 months or suicidal behavior within the past 6 months, or has a significant suicide risk in the investigator’s opinion
● Anyone who is unable to comply with study and follow-up tests