Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
Brief Summary: To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.


Options:
A: Inclusion Criteria:

* age 16 years of above at the time of screening
* ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
* Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
* Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (\>90% chronic irreversible scarring)
* Relapse or resistant to (3 consecutive doses) IVCY
* Resistant lupus or Relapse lupus nephritis defined as follows:

  * Increase in serum creatinine \>/= 0.3 mg/dl or
  * Increase in proteinuria \> 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
* Life-time cumulative dose of IVCY \> 6 grams
* Female patients of childbearing potential must have a negative serum pregnancy

Exclusion Criteria:

Relates to SLE

* Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
* Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR \< 30 ml/min(except creatinine clearance or MDRD-GFR \> 50 ml/min in the 12 weeks prior to screening)
* History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
* Severe extra-renal organ involvement

Related to Treatment

* Previous of any Mycophenolate groups in the 6 months prior to screening
* Treatment with any investigational drugs in the 3 months prior to screening

Related to General Health

* Pregnancy or breast feeding mothers.
* Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
* Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
* History of cancer, including solid tumors, hematological malignancies and carcinoma.
* Evidence of current abuse of drugs or alcohol.

Related to Laboratory Findings

* Neutrophile \< 1,500/mm3, Hb \< 7g/L, Platelet \< 50,000/mm3 (except active SLE)
* Positive HBsAg or anti-HCV or anti-HIV.
B: Inclusion Criteria:

1. Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN).
2. Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI\< 4，Scr\< 3 mg/dl.
3. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment.
4. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups.

Exclusion Criteria:

1. Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months.
2. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L).
3. Patients with severe infection or central nervous system symptoms.
4. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis.
5. Patients who have abnormal blood glucose, with a fasting blood glucose \> 6.2 mmol/L or post meal blood glucose \> 11.2 mmol/L.
6. Patients who are pregnant or lactating.
7. Patients who are known to be allergic to a macrolide.
C: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria.
* Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN), with either active or active/chronic disease.
* Proteinuria.
* 16-75 years of age.

Exclusion Criteria:

* Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
* Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions.
* Lack of peripheral venous access.
* Pregnancy or lactation.
* History of severe allergic or anaphylactic reactions to monoclonal antibodies.
* Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude subject participation.
* Concomitant chronic conditions, excluding SLE (eg, asthma, Crohn's disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening.
* History of renal transplant.
* Known human immunodeficiency virus (HIV) infection.
* Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization.
* History of deep space infection within 1 year of screening.
* History of serious recurrent or chronic infection.
* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinomas of the skin that have been treated or excised and have resolved).
* Currently active alcohol or drug abuse or history of alcohol or drug abuse within 52 weeks prior to screening.
* Major surgery requiring hospitalization within 4 weeks of screening (excluding diagnostic surgery).
* Treatment with cyclophosphamide or calcineurin inhibitors within the 90 days prior to screening.
* Use of mycophenolate mofetil (MMF) at a dose of \> 2 grams daily for longer than the 90 days prior to screening.
* Intolerance or history of allergic reaction to MMF.
* Intolerance or history of allergic reaction to both angiotensin-converting enzyme (ACE) inhibitors and angiotensin-receptor blockers.
* Use of oral prednisone (or corticosteroid equivalent) at a dose of \> 20 mg/day for longer than the 14 days prior to screening.
* Previous treatment with CAMPATH-1H (alemtuzumab).
* Previous treatment with a B-cell targeted therapy.
* Treatment with any investigational agent (including biologic agents approved for other indications) within 28 days of the start of the screening period or 5 half-lives of the investigational drug (whichever is longer).
* Receipt of a live vaccine within the 28 days prior to screening.
* Intolerance or contraindication to oral or IV corticosteroids.
* Current therapy with a nonsteroidal anti-inflammatory agent.
* Positive hepatitis B sAg or hepatitis C serology.
D: Inclusion Criteria:

* Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
* Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
* A stable serum creatinine ≤3 mg/dL

Exclusion Criteria:

* Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit
* Subjects with drug-induced SLE, as opposed to idiopathic SLE
* Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
* Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
* Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
* Subjects who have received treatment with rituximab \< 6 months prior to the screening visit

Answer: A