Clinical trial NCT00580229 (phase 2/phase 3, status: completed)
Conditions: rheumatoid arthritis
ICD codes: M06.9, M05.9, M06.08, M06.00, M06.011, M06.012, M06.019
Drugs: prednisone
SMILES: [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:

          -  American College of Rheumatology Criteria for Rheumatoid Arthritis

          -  Age 18-80

          -  Concomitant methotrexate (MTX) [oral or parenteral at any dose]

          -  IgG & IgM levels above lower limit of normal.

          -  Adequate renal function as indicated by serum creatinine of < or = 1.8

          -  Study subjects can be either MTX-inadequate responders or TNF-alpha antagonists
             inadequate responders

          -  Able and willing to give written informed consent and comply with the requirements of
             the study protocol

          -  Negative serum pregnancy test (for women of child bearing age)

          -  Men and women of reproductive potential must agree to use an acceptable method of
             birth control during treatment and for twelve months (1 year) after completion of
             treatment.

          -  If patients are on corticosteroids, they must be on a dose of < or = to prednisone
             10mg oral daily (or its equivalence) and the dose must remain stable for 4 weeks prior
             to their first rituximab infusion.

        Exclusion Criteria:

          -  An inflammatory arthritis other than RA

          -  ANC < 1.5 x 103

          -  Hemoglobin: < 8.0 gm/dL

          -  Platelets: < 100,000/mm

          -  AST or ALT >2.5 x Upper Limit of Normal unless related to primary disease.

          -  Positive Hepatitis B or C serology (Hep B Surface antigen and Hep C antibody)

          -  History of positive HIV (HIV conducted during screening if applicable)

          -  Treatment with any TNF-alpha antagonist within 8 weeks of Day 1 visit (for infliximab
             and adalimumab) or 4 weeks (for etanercept).

          -  Previous treatment with abatacept (Orencia) at any time.

          -  Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
             of the investigational drug (whichever is longer)

          -  Receipt of a live vaccine within 4 weeks prior to randomization

          -  Previous Treatment with Rituximab (MabThera® / Rituxan®)

          -  Previous treatment with Natalizumab (Tysabri®)

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

          -  History of recurrent significant infection or history of recurrent bacterial
             infections

          -  Known active bacterial, viral fungal mycobacterial, or other infection (including
             tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
             nail beds) or any major episode of infection requiring hospitalization or treatment
             with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks
             prior to screening

          -  Ongoing use of high dose steroids (>10mg/day) or unstable steroid dose in the past 4
             weeks

          -  Lack of peripheral venous access

          -  History of drug, alcohol, or chemical abuse within 6 months prior to screening

          -  Pregnancy (a negative serum pregnancy test should be performed for all women of
             childbearing potential within 7 days of treatment) or lactation

          -  Concomitant malignancies or previous malignancies within 5 years, with the exception
             of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in
             situ of the cervix

          -  History of psychiatric disorder that would interfere with normal participation in this
             protocol

          -  Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

          -  Any other disease, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or render the patient at high risk from treatment
             complications

          -  Inability to comply with study and follow-up procedures