Date

2015-09-25

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

1. Male or female subjects aged 18 to 75 years. 2. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria. 3. Kidney biopsy within 6 months prior to Screening (Visit 1) with a histologic diagnosis of lupus nephritis (International Society of Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G, (A) or (A/C); or Class V, alone or in combination with Class III or IV. 4. Laboratory evidence of active nephritis at screening, defined as: • Class III: Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24 hour urine collection • Class IV-S or Class IV-G: Confirmed proteinuria ?1,500 mg/24 hours when assessed by 24 hour urine collection • Class V (alone or in combination with Class III or IV): Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24 hour urine collection

Next Version

1. Male or female subjects aged 18 to 75 years inclusive at the time of screening. 2. Diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology criteria (1997; see Appendix 7) 3. Kidney biopsy within 6 months prior to screening (Visit I) with a histologic diagnosis of lupus nephritis (Nephrology/Renal Pathology Society 2003 classification of lupus nephritis) Classes III, IV-S or IV-G (A) or (A/C): or Class V, alone or in combination with Class III or IV: see Appendix 5. 4. Subjects with laboratory evidence of active nephritis at screening, defined as follows: • Class III, IV-S or IV-G: Confirmed proteinuria ? 1,500 mg/24 hours when assessed by 24- hour urine collection, defined by a urine protein/creatinine ratio (UPCR) of ?1.5 mg/mg assessed in a first morning void urine specimen (2 samples). • Class V (alone or in combination with class III or IV) Confirmed proteinuria ?2,000 mg/24 hours when assessed by 24-hour urine collection, defined by a UPCR of ?2 mg/mg assessd in a first morning void urine collection specimen (2 samples)