Clareo Health | A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
Moderate to severe RA with a DAS28-ESR score \>3.2 points
Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
Oral corticosteroids (less than or equal to \[\</=\] 10 mg per day prednisolone or equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to \[\>/=\] 4 weeks prior to baseline
Permitted non-biologic DMARDs allowed if at stable dose for \>/=4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab
Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA
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 or any other biologic DMARDs 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
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 concomitant disease or disorder
Known active current or history of recurrent infection
Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
Active tuberculosis requiring treatment within the previous 3 years
Positive for hepatitis B or hepatitis C
History of or current active primary or secondary immunodeficiency
Pregnant or lactating women
Neuropathies or other conditions that might interfere with pain evaluation
