Clinical trial NCT00282347 (phase 3, status: completed)
Conditions: lupus nephritis
ICD codes: B26.83, A51.44, N11.8, N11.9, N12
Drugs: rituximab, placebo, mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, prednisone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, N[C@@H](CCCNC(N)=N)C(O)=O, [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@]12C, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1, CC1=CC(O)=CC(C)=C1Cl, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        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.