Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of RA for at least 6 months.
Inadequate response to MTX
Use of folate
If female and of childbearing potential, have a negative serum pregnancy test within 8 weeks prior to first rituximab infusion
You may not be if
Diagnosis of juvenile idiopathic arthritis (also known as juvenile rheumatoid arthritis) and/or RA before age 16
Any surgical procedure, including bone/joint surgery or planned surgery within 8 weeks prior to screening or within 16 weeks of Week 1 (Day 1) visit
Inflammatory arthritis other than RA (e.g., inflammatory bowel disease, systemic lupus erythematosus (SLE), or psoriatic arthritis)
Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA
Use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks prior for infliximab, adalimumab, or leflunomide)
Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
Previous treatment with Tysabri\<TM\> (natalizumab)
Previous treatment with rituximab
Previous treatment with any cell-depleting therapies, including investigational agents
Treatment with IV \&-globulin or Prosorba(R) Column within the previous 6 months
Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit
Receipt of a vaccine within 4 weeks prior to Day 1 infusion
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Primary or secondary immunodeficiency (history of or active)
Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation over the ensuing 2 years
Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds)
History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
History of significant cytopenias or other bone marrow disorders
History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
Pregnant or nursing (breast feeding) women
Lack of peripheral venous access
Chronic daily use of narcotic analgesics
History of alcohol, drug, or chemical abuse within 6 months prior to screening
