TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

Launched by HOFFMANN-LA ROCHE · Jan 8, 2014

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult participants, \>/= 18 years of age
• • Active moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria or EULAR/ACR (2010) criteria
• • Inadequate response or intolerant to previous therapy with two or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate, administered in an optimal way during at least 3 months; eligible participants may also be inadequate responders to a maximum of one biologic DMARD
• • Oral corticosteroids (\</= 10 milligram per day (mg/day) prednisolone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the recommended dose) are permitted if on stable dose regimen for \>/= 4 weeks prior to baseline
• • Permitted DMARDs are allowed if at stable dose for at least 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 reliable means of contraception as defined by protocol
• Exclusion Criteria:
• • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline or during long term extension (LTE) period
• • Rheumatic autoimmune disease other than rheumatoid arthritis
• • Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
• • 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 (intravenous or subcutaneous) 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
• • Intraarticular 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 concomitant disease or disorder
• • Known active current or history of recurrent infection
• • 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 or hepatitis C
• • Primary or secondary immunodeficiency (history of or currently active)
• • Pregnant or lactating women
• • Neuropathies or other conditions that might interfere with pain evaluation
• • Inadequate hematologic, renal or liver function