Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Musculoskeletal Diseases
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orthe first anti-TNF agent (in monotherapy or in combination with MTX or othernon-biologic DMARDs). Inadequate response to anti-TNF treatment is defined as DAS28score improvement of less than 1.2 or participants achieving a DAS28 score improvementof 1.2 but not achieving low disease activity (current DAS28-ESR above 3.2) accordingto a treat-to-target strategy and have not been previously exposed to treatment withtocilizumab. Inadequate response to non-biologic DMARD therapy will be assessedaccording to local guidelines and the participants will need to be eligible forbiologic therapy according to local guidelines
Oral corticosteroids (≤10 mg/day prednisone or equivalent) and non-steroidalanti-inflammatory drugs (NSAIDs; up to recommended dose) are permitted if on stabledose 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 priorto baseline
Receiving treatment on an outpatient basis, not including tocilizumab
Females of childbearing potential and males with female partners of childbearingpotential must agree to use reliable means of contraception as defined by protocolduring the study and for at least 3 months following the last dose of tocilizumab
Exclusion
Exclusion Criteria:
Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following baseline
Rheumatic autoimmune disease other than RA
Functional Class IV as defined by the ACR Classification of Functional Status inRheumatoid 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 theinvestigational 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 murinemonoclonal antibodies
Known active current or history of recurrent infections
Major episode of infection requiring hospitalization or treatment with IV antibioticswithin 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
Study Design
Connect with a study center
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZN
United KingdomSite Not Available
Christchurch Hospital; Rheumatology
Bournemouth, BH23 2JX
United KingdomSite Not Available
Royal Sussex County Hospital; Clinical Investigation Research Unit
Brighton, BN2 5BE
United KingdomSite Not Available
Queens Hospital
Burton on Trent, DE13 0RB
United KingdomSite Not Available
West Suffolk Hospital
Bury Saint Edmonds, IP33 2QZ
United KingdomSite Not Available
empty
Bury St Edmonds, IP33 2QZ
United KingdomSite Not Available
Addenbrooke'S Hospital; Rheumatology Research Unit
Cambridge, CB2 2QQ
United KingdomSite Not Available
Cannock Chase Hospital; Rheumatology
Cannock, WS11 5XY
United KingdomSite Not Available
University Hospital of Wales; Dept of Rhematology
Cardiff, CF14 4XW
United KingdomSite Not Available
empty
Carshalton, SM5 1AA
United KingdomSite Not Available
Broomfield Hospital
Chelmsford, CM1 7ET
United KingdomSite Not Available
Countess of Chester Hospital; Dept of Rheumatology
Chester, CH2 1UL
United KingdomSite Not Available
Dewsbury & District Hospital; Dept of Rheumatology
Dewsbury, WF13 4HS
United KingdomSite Not Available
Russells Hall Hospital; Rheumatology Department
Dudley, DY1 2HQ
United KingdomSite Not Available
Ninewells Hospital
Dundee, DD12 9SY
United KingdomSite Not Available
Eastbourne District General Hospital; Dept of Rheumatology
Eastbourne, BN21 2UD
United KingdomSite Not Available
Western General Hospital; Pharmacy Department
Edinburgh, EH4 2XU
United KingdomSite Not Available
Gartnavel General Hospital; Rheumatology
Glasgow, G12 0YN
United KingdomSite Not Available
Diana Princess of Wales Hosp.
Grimsby, DN33 2BA
United KingdomSite Not Available
Princess Alexandra Hospital
Harlow, CM20 1QX
United KingdomSite Not Available
Northwick Park Hospital
Harrow, HA1 3UJ
United KingdomSite Not Available
Hemel Hempstead General Hospital; Rheumatology Dept
Hemel Hempstead, HP2 4AD
United KingdomSite Not Available
Hull Royal Infirmary; Rheumatology Department
Hull, HU3 3JZ
United KingdomSite Not Available
empty
Lancaster, LA1 4RP
United KingdomSite Not Available
Llandudno General Hospital
Llandudno, LL30 1LB
United KingdomSite Not Available
Royal Free Hospital; Department of Rheumatology
London, NW3 2QG
United KingdomSite Not Available
Whipps Cross Hospital; Rheumatology Dept
London, E11 1NR
United KingdomSite Not Available
Maidstone Hospital; Dept of Rheumatology
Maidstone, ME16 9QQ
United KingdomSite Not Available
Wythenshawe Hospital
Manchester, M23 9QZ
United KingdomSite Not Available
Freeman Hospital; Dept of Rheumatology
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
North Tyneside General Hospital
North Shields, NE29 8NH
United KingdomSite Not Available
Norfolk & Norwich Hospital; Rheumatology
Norwich, NR4 7UY
United KingdomSite Not Available
Integrated Care Centre
Oldham, OL1 1NL
United KingdomSite Not Available
Solihull Hospital
Solihull, B91 2JL
United KingdomSite Not Available
Haywood Hospital; Staffordshire Rheumatology Centre
Stoke-on-trent, ST6 7AG
United KingdomSite Not Available
Great Western Hospital; Dept of Rheumatology
Swindon, SN3 6BB
United KingdomSite Not Available
Torbay Hospital; Dept of Rhematology
Torquay, TQ2 7AA
United KingdomSite Not Available
Royal Cornwall Hospital; Rhuematololgy Dept
Truro, TR1 3LJ
United KingdomSite Not Available
Warrington Hospital
Warrington, WA5 1QG
United KingdomSite Not Available
Wrightington Hospital; Rheumatology
Wigan, WN6 9EW
United KingdomSite Not Available
Wishaw General Hospital
Wishaw, ML2 0DP
United KingdomSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.