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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)
CompletedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Rheumatoid Arthritis
Interventions: Tocilizumab, Methotrexate, Non-Biologic DMARDs
Countries: Denmark, Finland, Norway, Sweden
This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Inadequate hematologic, renal, or liver function
Locations (27)
- Aalborg, Denmark
- Glostrup Municipality, Denmark
- Hellerup, Denmark
- Holbæk, Denmark
- Køge, Denmark
- Odense, Denmark
- Svendborg, Denmark
- Helsinki, Finland
- Hyvinkää, Finland
- Joensuu, Finland
- Jyväskylä, Finland
- Lappeenranta, Finland
- Oulu, Finland
- Ålesund, Norway
- Bergen, Norway
- Drammen, Norway
- Oslo, Norway
- Trondheim, Norway
- Jönköping, Sweden
- Linköping, Sweden
- Lund, Sweden
- Malmö, Sweden
- Örebro, Sweden
- Simrishamn, Sweden
- Stockholm, Sweden
- Uppsala, Sweden
- Västerås, Sweden