Ensayos clínicos

Inclusion Criteria:

- Age ≥ 18 years of age.

- Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.

- Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on
International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12
months of enrollment.

- Proteinuria ≥ 500 mg over 24 hours.

- eGFR ≥ 30 ml/min/SA.

- Subjects should be able to give informed consent.

Exclusion Criteria:

- Pregnancy.

- Hepatitis B or C, HIV

- Anemia with Hgb < 8.0 g/dL.

- Thrombocytopenia with platelet count < 100'000.

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication.

- Unable to provide consent.

- Patients receiving > 10 mg of oral prednisone or glucocorticoid equivalent if on
corticosteroids for > 2 weeks (patients would be allowed to be on > 10 mg of
prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).

- Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus
or azathioprine in the last 3 months.

- Patients who have received cyclophosphamide in the last 6 months.

- Patients who received rituximab previously with CD20 count of zero at the time of
enrollment.

- Patient are allowed to be on MMF at time of enrollment but no higher than total of
1500mg/day.

- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea)
or surgically sterile (absence of ovaries and/or uterus): agreement to remain
abstinent or use two adequate methods of contraception, including at least one method
with a failure rate of less than (<) 1 percent (%) per year, during the treatment
period and for at least 12 months after the last dose of study drug.

- For men: agreement to remain abstinent or use a condom plus an additional
contraceptive method that together result in a failure rate of < 1% per year during
the treatment period and for at least 12 months after the last dose of study drug and
agreement to refrain from donating sperm during this same period.

- Patients with diagnosis of glaucoma.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.