lupus nephritis MedDRA version: 20.0 Level: LLT Classification code 10029142 Term: Nephritis systemic lupus erythematosus System Organ Class: 100000004857 MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Rixathon
Product Code: [045450032]
Pharmaceutical Form: Concentrate for solution for injection/infusion
CAS Number: 174722-31-7
Current Sponsor code: ASL Città di Torino
Concentration un
Sponsors
A.S.L. TO 2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Condition or disease: Biopsy Proven Lupus Nephritis class III, IV, V Number of enrolled patients: 54 Eligibility: Ages Eligible for Study: 18 Years or older Sexes Eligible for Study: All Inclusion Criteria: All the following inclusion criteria are to be met: - SLE, according to SLICC (Arthritis Rheum 2012; May 2; doi: 10.1002/art.34473) criteria ; - ISN/RPS 2003 Class III (A or A/C), IV (A or A/C ; S or G) or V lupus GN confirmed on renal biopsy performed within six months before randomization. -Contraception (any type); -Signed informed consent (drafted according to local practice and approved by the local ethics committee). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: Any of the following: - Pregnancy or breast-feeding; -Anticipated non-compliance with the protocol - History of malignancy (except non-melanoma skin and cervical intraepithelial cancer) ; - Previous treatment with RTX (whenever) and previous treatment with another biologic agent within the last 6 months; - HIV infection; - Active HBV/HCV/TB infection; - Severe liver, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic or psychiatric disturbances, that would contraindicate inclusion in the protocol, as judged by the clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In this prospective open label randomized control trial, researchers will investigate if treatment of lupus nephritis with a short term (3 months) intensified B-Cell depletion therapy (IBCDT) consisting of a combination of glucorticoids (GCs), rituximab (RTX) and cyclophosphamide (CYC), is safe and equally effective compared to a standard regimen of GCs and mycophenolate mofetil (MMF) for induction (3-6 months) followed by MMF as a maintenance therapy for at least 2 years. Additionally, the steroid sparing effects of the IBCD as compared to the standard regimen will be evaluated. Primary: Complete renal remission at 12 months Complete renal remission at 30 months;Secondary Objective: Secondary: a)safety profile of the regimens and rate of side effects b)steroid-sparing effect c)response as assessed by the Systemic Lupus Erythematosus Activity Index 2000 (SLEDAI-2K) d)changes in immunological and biochemical parameters e)relapse profile;Primary end point(s): Primary: Complete renal remission at 12 months Complete renal remission at 30 months;Timepoint(s) of evaluation of this end point: Primary: Complete renal remission at 12 months Complete renal remission at 30 months | — |
Countries
Italy
Contacts
Public ContactCMID - Nefrologia
ASL Città di Torino
Outcome results
None listed