Clinical trial NCT00137969 (phase 2/phase 3, status: completed)
Conditions: lupus erythematosus, systemic
ICD codes: M32.9, M32.0, M32.11, M32.12, M32.13, M32.14, M32.8
Drugs: rituximab, placebo, prednisone, acetaminophen, diphenhydramine
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, [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, CC1=CC(O)=CC(C)=C1Cl, CN(C)CCOC(C1=CC=CC=C1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of systemic lupus erythematosus (SLE).

          -  Active disease at screening.

          -  Stable use of one immunosuppressive drug.

          -  Use of an antimalarial drug.

          -  For subjects of reproductive potential (males and females), use of a reliable means of
             contraception throughout their study participation.

        Exclusion Criteria:

          -  Unstable patients 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.

          -  Active moderate to severe glomerulonephritis.

          -  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.

          -  Lack of peripheral venous access.

          -  Pregnant women or nursing (breast feeding) mothers.

          -  History of severe, allergic, or anaphylactic reactions to humanized or murine
             monoclonal antibodies.

          -  Significant, uncontrolled medical disease in any organ system not related to SLE that
             in the investigator's opinion would preclude subject participation.

          -  Concomitant conditions that require oral or systemic corticosteroid use.

          -  Known human immunodeficiency virus (HIV) infection.

          -  Known active infection of any kind (excluding fungal infection of nail beds) or any
             major episode of infection requiring hospitalization or treatment with intravenous
             (IV) antibiotics.

          -  History of deep space infection.

          -  History of serious recurrent or chronic infection.

          -  History of cancer, including solid tumors, hematological malignancies, and carcinoma
             in situ.

          -  Active alcohol or drug abuse, or history of alcohol or drug abuse.

          -  Major surgery.

          -  Previous treatment with CAMPATH-1H antibody.

          -  Previous treatment with any B cell-targeted therapy.

          -  Treatment with any investigational agent within 28 days of screening (Day -7) or 5
             half-lives of the investigational drug (whichever is longer).

          -  Receipt of a live vaccine within 28 days prior to screening.

          -  Intolerance or contraindication to oral or IV corticosteroids.

          -  Use of a new immunosuppressive drug prior to screening or change in dose of ongoing
             immunosuppressive drug prior to screening.

          -  Prednisone dose of ≥ 1 mg/kg/day prior to screening.

          -  Treatment with cyclophosphamide or a calcineurin inhibitor.

          -  Treatment with a second immunosuppressive or immunomodulatory drug.

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x the upper
             limit of normal.