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

Last updated: May 25, 2018
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

N/A

Clinical Study ID

NCT02046603
ML28641
2013-000054-22
  • Ages > 18
  • All Genders

Study Summary

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 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

Total Participants: 162
Study Start date:
March 04, 2014
Estimated Completion Date:
August 04, 2016

Connect with a study center

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Christchurch Hospital; Rheumatology

    Bournemouth, BH23 2JX
    United Kingdom

    Site Not Available

  • Royal Sussex County Hospital; Clinical Investigation Research Unit

    Brighton, BN2 5BE
    United Kingdom

    Site Not Available

  • Queens Hospital

    Burton on Trent, DE13 0RB
    United Kingdom

    Site Not Available

  • West Suffolk Hospital

    Bury Saint Edmonds, IP33 2QZ
    United Kingdom

    Site Not Available

  • empty

    Bury St Edmonds, IP33 2QZ
    United Kingdom

    Site Not Available

  • Addenbrooke'S Hospital; Rheumatology Research Unit

    Cambridge, CB2 2QQ
    United Kingdom

    Site Not Available

  • Cannock Chase Hospital; Rheumatology

    Cannock, WS11 5XY
    United Kingdom

    Site Not Available

  • University Hospital of Wales; Dept of Rhematology

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • empty

    Carshalton, SM5 1AA
    United Kingdom

    Site Not Available

  • Broomfield Hospital

    Chelmsford, CM1 7ET
    United Kingdom

    Site Not Available

  • Countess of Chester Hospital; Dept of Rheumatology

    Chester, CH2 1UL
    United Kingdom

    Site Not Available

  • Dewsbury & District Hospital; Dept of Rheumatology

    Dewsbury, WF13 4HS
    United Kingdom

    Site Not Available

  • Russells Hall Hospital; Rheumatology Department

    Dudley, DY1 2HQ
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee, DD12 9SY
    United Kingdom

    Site Not Available

  • Eastbourne District General Hospital; Dept of Rheumatology

    Eastbourne, BN21 2UD
    United Kingdom

    Site Not Available

  • Western General Hospital; Pharmacy Department

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

  • Gartnavel General Hospital; Rheumatology

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Diana Princess of Wales Hosp.

    Grimsby, DN33 2BA
    United Kingdom

    Site Not Available

  • Princess Alexandra Hospital

    Harlow, CM20 1QX
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow, HA1 3UJ
    United Kingdom

    Site Not Available

  • Hemel Hempstead General Hospital; Rheumatology Dept

    Hemel Hempstead, HP2 4AD
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary; Rheumatology Department

    Hull, HU3 3JZ
    United Kingdom

    Site Not Available

  • empty

    Lancaster, LA1 4RP
    United Kingdom

    Site Not Available

  • Llandudno General Hospital

    Llandudno, LL30 1LB
    United Kingdom

    Site Not Available

  • Royal Free Hospital; Department of Rheumatology

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Whipps Cross Hospital; Rheumatology Dept

    London, E11 1NR
    United Kingdom

    Site Not Available

  • Maidstone Hospital; Dept of Rheumatology

    Maidstone, ME16 9QQ
    United Kingdom

    Site Not Available

  • Wythenshawe Hospital

    Manchester, M23 9QZ
    United Kingdom

    Site Not Available

  • Freeman Hospital; Dept of Rheumatology

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • North Tyneside General Hospital

    North Shields, NE29 8NH
    United Kingdom

    Site Not Available

  • Norfolk & Norwich Hospital; Rheumatology

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Integrated Care Centre

    Oldham, OL1 1NL
    United Kingdom

    Site Not Available

  • Solihull Hospital

    Solihull, B91 2JL
    United Kingdom

    Site Not Available

  • Haywood Hospital; Staffordshire Rheumatology Centre

    Stoke-on-trent, ST6 7AG
    United Kingdom

    Site Not Available

  • Great Western Hospital; Dept of Rheumatology

    Swindon, SN3 6BB
    United Kingdom

    Site Not Available

  • Torbay Hospital; Dept of Rhematology

    Torquay, TQ2 7AA
    United Kingdom

    Site Not Available

  • Royal Cornwall Hospital; Rhuematololgy Dept

    Truro, TR1 3LJ
    United Kingdom

    Site Not Available

  • Warrington Hospital

    Warrington, WA5 1QG
    United Kingdom

    Site Not Available

  • Wrightington Hospital; Rheumatology

    Wigan, WN6 9EW
    United Kingdom

    Site Not Available

  • Wishaw General Hospital

    Wishaw, ML2 0DP
    United Kingdom

    Site Not Available

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