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
NCT ID: NCT02046603
Last Updated: 2018-12-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
162 participants
INTERVENTIONAL
2014-03-04
2016-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tocilizumab Monotherapy
Participants will receive a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks.
Tocilizumab
Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.
Tocilizumab in Combination With Methotrexate or Other DMARDs
Participants will receive a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.
Tocilizumab
Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.
DMARDs
Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.
Oral Corticosteroids
Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.
Methotrexate
Methotrexate per investigator's discretion.
Interventions
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Tocilizumab
Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.
DMARDs
Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.
Oral Corticosteroids
Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.
Methotrexate
Methotrexate per investigator's discretion.
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aberdeen Royal Infirmary
Aberdeen, , United Kingdom
Christchurch Hospital; Rheumatology
Bournemouth, , United Kingdom
Royal Sussex County Hospital; Clinical Investigation Research Unit
Brighton, , United Kingdom
Queens Hospital
Burton-on-Trent, , United Kingdom
West Suffolk Hospital
Bury Saint Edmonds, , United Kingdom
Addenbrooke'S Hospital; Rheumatology Research Unit
Cambridge, , United Kingdom
Cannock Chase Hospital; Rheumatology
Cannock, , United Kingdom
University Hospital of Wales; Dept of Rhematology
Cardiff, , United Kingdom
Broomfield Hospital
Chelmsford, , United Kingdom
Countess of Chester Hospital; Dept of Rheumatology
Chester, , United Kingdom
Dewsbury & District Hospital; Dept of Rheumatology
Dewsbury, , United Kingdom
Russells Hall Hospital; Rheumatology Department
Dudley, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Eastbourne District General Hospital; Dept of Rheumatology
Eastbourne, , United Kingdom
Western General Hospital; Pharmacy Department
Edinburgh, , United Kingdom
Gartnavel General Hospital; Rheumatology
Glasgow, , United Kingdom
Diana Princess of Wales Hosp.
Grimsby, , United Kingdom
Princess Alexandra Hospital
Harlow, , United Kingdom
Northwick Park Hospital
Harrow, , United Kingdom
Hemel Hempstead General Hospital; Rheumatology Dept
Hemel Hempstead, , United Kingdom
Hull Royal Infirmary; Rheumatology Department
Hull, , United Kingdom
Llandudno General Hospital
Llandudno, , United Kingdom
Whipps Cross Hospital; Rheumatology Dept
London, , United Kingdom
Royal Free Hospital; Department of Rheumatology
London, , United Kingdom
Maidstone Hospital; Dept of Rheumatology
Maidstone, , United Kingdom
Wythenshawe Hospital
Manchester, , United Kingdom
Freeman Hospital; Dept of Rheumatology
Newcastle upon Tyne, , United Kingdom
North Tyneside General Hospital
North Shields, , United Kingdom
Norfolk & Norwich Hospital; Rheumatology
Norwich, , United Kingdom
Integrated Care Centre
Oldham, , United Kingdom
Solihull Hospital
Solihull, , United Kingdom
Haywood Hospital; Staffordshire Rheumatology Centre
Stoke-on-Trent, , United Kingdom
Great Western Hospital; Dept of Rheumatology
Swindon, , United Kingdom
Torbay Hospital; Dept of Rhematology
Torquay, , United Kingdom
Royal Cornwall Hospital; Rhuematololgy Dept
Truro, , United Kingdom
Warrington Hospital
Warrington, , United Kingdom
Wrightington Hospital; Rheumatology
Wigan, , United Kingdom
Wishaw General Hospital
Wishaw, , United Kingdom
Countries
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References
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Isaacs JD, Salih A, Sheeran T, Patel YI, Douglas K, McKay ND, Naisbett-Groet B, Choy E. Efficacy and safety of subcutaneous tocilizumab in rheumatoid arthritis over 1 year: a UK real-world, open-label study. Rheumatol Adv Pract. 2019 Apr 19;3(1):rkz010. doi: 10.1093/rap/rkz010. eCollection 2019.
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.
Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.
Other Identifiers
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2013-000054-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML28641
Identifier Type: -
Identifier Source: org_study_id