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A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent

NCT02046603

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: Tocilizumab, DMARDs, Oral Corticosteroids, Methotrexate

Countries: United Kingdom

This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 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 (1987) ACR criteria or EULAR/ACR (2010) criteria
* Participants who have an inadequate response to current non-biologic DMARD therapy or the first anti-TNF agent (in monotherapy or in combination with MTX or other non-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28 score improvement of less than 1.2 or participants achieving a DAS28 score improvement of 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) according to a treat-to-target strategy and have not been previously exposed to treatment with tocilizumab. Inadequate response to non-biologic DMARD therapy will be assessed according to local guidelines and the participants will need to be eligible for biologic therapy according to local guidelines
* Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stable dose regimen for greater than or equal to \[≥\] 4 weeks prior to baseline
* Permitted non-biologic DMARDs are allowed if on 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 during the study and for at least 3 months following the last dose of tocilizumab

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 either intravenous 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
* 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
* Known active current or history of recurrent infections
* 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 virus infection
* Primary or secondary immunodeficiency (history of or currently active)
* Pregnant or lactating women
* Inadequate hematologic, renal or liver function

Locations (38)

Aberdeen, United Kingdom
Bournemouth, United Kingdom
Brighton, United Kingdom
Burton-on-Trent, United Kingdom
Bury Saint Edmonds, United Kingdom
Cambridge, United Kingdom
Cannock, United Kingdom
Cardiff, United Kingdom
Chelmsford, United Kingdom
Chester, United Kingdom
Dewsbury, United Kingdom
Dudley, United Kingdom
Dundee, United Kingdom
Eastbourne, United Kingdom
Edinburgh, United Kingdom
Glasgow, United Kingdom
Grimsby, United Kingdom
Harlow, United Kingdom
Harrow, United Kingdom
Hemel Hempstead, United Kingdom
Hull, United Kingdom
Llandudno, United Kingdom
London, United Kingdom
London, United Kingdom
Maidstone, United Kingdom
Manchester, United Kingdom
Newcastle upon Tyne, United Kingdom
North Shields, United Kingdom
Norwich, United Kingdom
Oldham, United Kingdom
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