MedDRA version: 9.1 Level: SOC Classification code 10028395 MedDRA version: 9.1 Level: LLT Classification code 10040970
Conditions
Interventions
Product Name: ABETIMUS SODIUM
Product Code: LJP394
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RIQUENT
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concen
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA DELLA SECONDA UNIVERSITA` DEGLI STUDI DI NAPOLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Systemic Lupus Erythematosus (SLE) classified according to the American College of Rheumatology criteria. Previous SLE renal disease within four years and presence of serum anti-dsDNA antibodies at the time of enrollement. Male or female, age 15-70 years. Ability to give an informed consent. Women should not be pregnant or breast-feeding. Patients of both sex will use an acceptable method of birth control during the study. Possibility and availability to submit to weekly intravenous injections for the duration of treatment. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Evidence of renal flare within three months of screening; treatment with alkylating agents (as cyclophosphamide), anti-TNF, cyclosporine within three months of screening; within two months of screening treatment with mycophenolate mofetile >1g/day, azatioprine >100 mg/day, methotrexate >10 mg/week, leflunomide >10mg/day; treatment with Rituximab within six months of screening; serum creatinine level = or > 2.5 mg/dL; pregnancy or lactation; alcoholism or drugs using.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The time to a documented renal flare and the number of renal flares.To determine the efficacy of Abetimus Sodium in the prevention of renal flares in patients with SLE and a history of renal disease;Secondary Objective: To gain informations on the effect of abetimus on: markers related to its mechanism of action (titre of anti-dsDNA antibodies, levels of circulating C3 and of IL-18); levels of urinary MCP-1; steroid-sparing effects; health-related quality of life (SF36), disease activity (ECLAM) and damage (SLICC).;Primary end point(s): The primary objectives are delay of the time to a documented renal flare and reduction of the incidence of documented renal flares in SLE patients on Abetimus, in comparison with placebo, during 32 months. A protocol-defined renal flare requires that it be attributed to SLE by the treating physician. In addition, 1 or more of the following 3 criteria were required: 1) a reproducible increase in 24-hour urine protein levels to (a) >1,000 mg if the baseline value was 2,000 mg if the baseline value was 200-1,000 mg, or (c) more than twice the value at baseline if the baseline value was >1,000 mg; 2) a reproducible increase in serum creatinine of >20% or at least 0.3 mg/dl, whichever was greater, accompanied by proteinuria (>1,000 mg/24 hours), hematuria (>4 RBCs/high-power field), and/or RBC casts; or 3) new, reproducible hematuria (>11-20 RBCs/high-power field) or a reproducible increase in hematuria by 2 grades compared with baseline, associated with >25% dysmorphic RBCs, glomerular in origin, exclusive of menses, accompanied by either an 800-mg increase in 24-hour urinary protein levels or new RBC casts. | — |
Countries
Italy
Outcome results
None listed