None listed
Conditions
Interventions
Group 1 Type of group
Infusion i.v. of ocrelizumab 1000 mg on days 1 and 15, followed by 1000 mg i.v. Week 16 and then every 16 weeks.
Group name:Group 3 Type of group
Infusion i.v. placebo on days 1 and 15, followed by placebo infusion on Week 16 and then every 16 weeks.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: • 16 years of age or older at the time of selection. • Ability and willingness to provide written informed consent (or obtain the consent of a family tutor, when appropriate) and comply with the schedule of protocol requirements. • Diagnosis of SLE according to the ACR criteria (see Appendix 4). At least 4 criteria must have been present for the diagnosis of SLE. It is not necessary that the 4 criteria are present at the time of selection. • Active lupus nephritis defined as follows: NL Class III or IV [exclusive III (C), IV-S (C) and IV-G (C)] according to WHO or ISN confirmed by biopsy (within 6 months prior to randomization). Patients may present Class V (see Table 1) coexisting. When possible, biopsies should be classified and reported according to the ISN / RPS classification scheme. And presence of: protein index in urine to creatinine in urine (Upr: Ucr)> 1 (which should not have improved 50% in the previous 6 months). • Patients with reproductive potential (men and women) should use a reliable contraceptive method during the study (eg, hormonal contraceptive, intrauterine device, barrier method) according to local regulations and the recommendations of the attending physician. The relevant section of the product information of CYC, MMF or AZA must be respected (as applicable). • Women with a capacity to procreate must present a negative serum pregnancy test at the screening visit prior to enrollment on Day 1.
Exclusion criteria
Exclusion criteria: • Currently active retinitis, poorly controlled seizure disorder, acute state of confusion, myelitis, stroke or CVA syndrome, cerebellar ataxia or dementia. • Severe renal insufficiency, defined by the calculated IFG (by Cockroft-Gault) 50% of glomeruli with sclerosis or> 50% interstitial fibrosis in the renal biopsy). • Absence of peripheral venous access. • Pregnancy or nursing mothers. • History of severe anaphylactic or allergic reactions to humanized, chimeric or murine monoclonal antibodies or immunoglobulin i.v. • Known severe chronic lung disease (FEV1 20 mg / day for more than 14 days before selection. During the 14 days p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A complete renal response (CRR) is defined as follows: 1. Creatinine in normal serum (and with an increase of not more than 25% from baseline) 2. Inactive urine sediment 3. Improvement in the protein index in urine to creatinine in urine to <0.5. Measure:Patients who achieve a Complete Renal Response Timepoints:week 48 ; Outcome name:A partial renal response (RRPI is defined as follows: A reduction of at least 50% in proteinuria from baseline, with an increase of no more than 25% of serum creatinine in week 48 compared to the evaluation basal. Measure:Patients who reach a partial renal response Timepoints:week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• Proportion of patients that reach a renal response (partial or complete) in Week 36 and maintain or improve this response until Week 48. • Proportion of patients that reach a complete renal response in Week 48. • Proportion of patients that reach a complete or partial renal response in Week 48. • Time to complete renal response. • AUC of IFGc between the baseline evaluation and week 48. Measure:Disease activity in Week 48 Timepoints:week 48 ; Outcome name:• Proportion of patients that achieve a renal response (partial or complete) and maintain or improve this response for 48 weeks. • Time to the first renal exacerbation, of those patients who demonstrate at least a partial renal response. Measure:Disease activity after Week 48 Timepoints:week 48 ; Outcome name:• Proportion of patients achieving a clinically significant improvement in scores of the physical and mental component of SF 38 Week 48 compared to the baseline assessment. • Proportion of patients achieving a clinically significant improvement in fatigue using the Facit-Fatigue questionnaire Week 48 compared to the baseline assessment. Measure:Quality of life Timepoints:week 48 | — |
Countries
Peru, United States
Contacts
Public ContactGabriela Celina Loyola
IQVIA RDS Peru S.R.L
Outcome results
None listed