Clareo Health | A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants
A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants
Oral corticosteroids (less than or equal to \[\</=\] 10 mg per day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted if on a stable dose regimen for \>/=4 weeks prior to baseline
Permitted non-biologic DMARDs are allowed if at a stable dose for \>/=4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab
Females of childbearing potential and males with female partners of childbearing potential must agree to use a reliable means of contraception for at least 3 months following the last dose of tocilizumab
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 12 months following baseline
Rheumatic autoimmune disease other than RA; secondary Sjögren's syndrome with RA is permitted
Functional Class IV as defined by the ACR Classification of Functional Status in RA
Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16
Prior history of or current inflammatory joint disease other than RA
Exposure to tocilizumab (either intravenous \[IV\] or SC) at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening
Previous treatment with any cell-depleting therapies
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal disease
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections
Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
Active tuberculosis (TB) requiring treatment within the previous 3 years
Positive for hepatitis B surface antigen or hepatitis C antibody
Primary or secondary immunodeficiency (history of or currently active)
Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except for basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured), or breast cancer diagnosed within the previous 20 years
Pregnant or breast feeding women
Neuropathies or other conditions that might interfere with pain evaluation
