Clinical trial NCT00626197 (phase 3, status: terminated)
Conditions: lupus nephritis, systemic lupus erythematosus
ICD codes: B26.83, A51.44, N11.8, N11.9, N12, M32.9, M32.0, M32.11, M32.12, M32.13, M32.14, M32.8
Drugs: corticosteroids, cyclophosphamide, mycophenolate mofetil, ocrelizumab, placebo, azathioprine
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, ClCCN(CCCl)P1(=O)NCCCO1, N[C@@H](CCCNC(N)=N)C(O)=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O
Reason stopped: 
    study was terminated due to an imbalance of serious and opportunistic infections in the
    ocrelizumab treated patients versus the placebo arm.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Age 16 years or above at the time of the screening

          -  Ability and willingness to provide written informed consent and to comply with the
             schedule of protocol requirements

          -  Diagnosis of SLE

          -  Active lupus nephritis

        Exclusion Criteria:

          -  Currently active retinitis, poorly controlled seizure disorder, acute confusional
             state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia

          -  Severe renal impairment

          -  Lack of peripheral venous access

          -  Pregnancy or breast feeding mothers

          -  History of severe allergic or anaphylactic reactions to humanized, chimeric or murine
             monoclonal antibodies or i.v. immunoglobulin

          -  Known severe chronic pulmonary disease

          -  Evidence of significant uncontrolled concomitant diseases in any organ system not
             related to SLE, which, in the investigator's opinion, would preclude patient
             participation

          -  Concomitant condition which has required treatment with systemic corticosteroid
             (excluding topical or inhaled steroids) prior to screening

          -  Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection

          -  Known active infection of any kind prior to Day 1

          -  History of serious recurrent or chronic infection

          -  History of cancer, including solid tumors, hematological malignancies and carcinoma in
             situ (except basal cell carcinoma of the skin that has been excised and cured).

          -  History of alcohol or drug abuse prior to screening

          -  Major surgery prior to screening, excluding diagnostic surgery

          -  Previous treatment with CAMPATH-1H

          -  Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) prior to screening

          -  Previous treatment with a B-cell targeted therapy other than one directed at BAFF
             (e.g. anti-CD20, anti-CD22)

          -  Treatment with any investigational agent prior to screening

          -  Receipt of any live vaccines prior to Day 1

          -  Intolerance or contraindication to oral or i.v. corticosteroids

          -  Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but
             HBcAb positive may be enrolled with a negative DNA test