Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Biogen
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active rheumatoid arthritis (RA) for ≥ 6 months
Receiving treatment for RA on an outpatient basis
Have had an inadequate response to at least one non-biological disease-modifying anti-rheumatic drug (DMARD) and have been receiving this DMARD(s) for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline
Demonstrated tolerability to currently prescribed DMARDs
If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to the first day of treatment with rituximab (Day 1)
Use of one nonsteroidal anti-inflammatory drug (NSAID) is permitted if the dose is stable for ≥ 2 weeks prior to Day 1
Male or female subjects, between 18 and 80 years of age, who have a documented diagnosis of active RA for ≥ 6 months, diagnosed according to the revised 1987 ACR criteria for the classification of RA
Receiving treatment for RA on an outpatient basis
Have had an inadequate response to at least one biologic DMARD and have been receiving this agent at screening and for ≥ 12 weeks prior to baseline, with stable dose greater than or equal to 4 weeks prior to baseline
Have demonstrated tolerability to currently prescribed DMARDs/biologics
If taking a background corticosteroid, use of the corticosteroid must be at a stable dose during the 4 weeks prior to baseline
Use of one NSAID is permitted if the dose is stable for ≥ 2 weeks prior to baseline
You may not be if
Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)
Functional Class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis
History of or current inflammatory joint disease other than RA or other systemic autoimmune disorder
Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years
Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of enrollment
Lack of peripheral venous access
Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine, or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation
Primary or secondary immunodeficiency (history of or currently active), including known history of human immunodeficiency virus (HIV) infection
Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline
History of medically significant opportunistic infection
History of serious recurrent or chronic infection
History of deep space/tissue infection within 52 weeks prior to baseline
History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
History of significant cytopenias or other bone marrow disorders
History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline
Pregnancy or lactation
Neuropathies and neurovasculopathies that might interfere with pain evaluation
Methotrexate (MTX) monotherapy at the time of screening
Concurrent treatment with MTX and leflunomide in combination
Concurrent treatment with any biologic agent
Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol
History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins
Previous treatment with an anti-α4 integrin agent
Previous treatment with any cell-depleting therapies, including investigational agents
Receipt of any vaccine within 28 days prior to baseline
Intolerance or contraindications to IV corticosteroids
Receipt of IV immunoglobulin (IVIG) or Prosorba\<TM\> column within 6 months prior to baseline
Any previous treatment with rituximab
Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome)
Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
History of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
Diagnosis of juvenile idiopathic arthritis, or juvenile RA, and/or RA before age 16 years
Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned within 24 weeks of randomization
Lack of peripheral venous access
Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
Evidence of significant uncontrolled concomitant disease such as, but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders that, in the investigator's opinion, would preclude subject participation
Primary or secondary immunodeficiency (history of or currently active), including known history of HIV infection
Known active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of baseline or completion of oral antibiotics within 2 weeks prior to baseline
History of medically significant opportunistic infection
History of serious recurrent or chronic infection
History of deep space/tissue infection within 52 weeks prior to baseline
History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ (except basal cell and squamous cell carcinoma of the skin that have been excised and cured)
History of significant cytopenias or other bone marrow disorders
History of alcohol, drug, or chemical abuse within 24 weeks prior to baseline
Pregnancy or lactation
Neuropathies and neurovasculopathies that might interfere with pain evaluation
Infliximab monotherapy at the time of screening (infliximab should be in combination with MTX)
Concurrent treatment with MTX and leflunomide in combination
Concurrent treatment with more than one biologic agent
Prior to Day 1, subjects will be discontinued from all DMARDs/combinations that are prohibited in the protocol
History of a severe allergic or anaphylactic reaction to a biologic agent, or known hypersensitivity to any component of rituximab or to murine proteins
Previous treatment with an anti-α4 integrin agent
Previous treatment with any cell-depleting therapies
Treatment with any investigational agent within 28 days of baseline or 5 half-lives of the investigational drug (whichever is the longer)
Receipt of any vaccine within 28 days prior to baseline
Intolerance or contraindications to IV corticosteroids
Receipt of IVIG or Prosorba\<TM\> column within 6 months prior to baseline
Any previous treatment with rituximab
Positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody
Positive purified protein derivative (PPD) skin test not adequately treated according to Center for Disease Control (CDC) guidelines
