Institutional Review Board, Hospital for Special Surgery
October 01, 2014
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.
• 3 patients
• Screen (4 weeks)
• Treatment (24 weeks)
• Follow-up (24 weeks)
• 13 clinic visits during the 48 month study + Screening visit
Inclusion Criteria (selected):
1. Male or female of ≥18 years of age
2. Diagnosis of SLE satisfying at least 4 out of the 11 ACR classification criteria
3. Disease duration of at least 6 months from the time of diagnosis
4. SLEDAI-2K score ≥6 at screening visit.
History of vaccinations against S. pneumococcus and influenza virus (as seasonally required),or vaccination against these pathogens at the screening visit. Subjects receiving one or more of these vaccinations at the screening visit must have at least 2 weeks between the vaccination and the date of randomization. (Live or live-attenuated vaccines are not permitted
Exclusion Criteria (selected) :
2. Within 2 weeks prior to screening visit: Use of corticosteroids (CS) exceeding 40 mg daily prednisone or equivalent. Increase in dosing of CS, or Use of injectable CS
3. Introduction of mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) within2 months prior to screening , increase in dosing within 1 month before screening , or use of intravenous mycophenolic acid(MPA or mycophenolate) in the 2 months prior to screening
4. Use of cyclophosphamide within 3 months before screening
5. Use of belimumab (or other anti-BLyS therapy) rituximab, ocrelizumab, or other B cell-directed biologic therapies within 1 year before screening