TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

Last updated: June 23, 2017
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT02031471
ML28701
  • Ages > 18
  • All Genders

Study Summary

This open-label, single-arm study will evaluate the efficacy, safety and tolerability of subcutaneously administered tocilizumab in monotherapy and/or in combination with methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants who complete the core study achieving at least a moderate European League Against Rheumatism (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks at the most.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult participants, >/= 18 years of age

  • Active moderate to severe rheumatoid arthritis according to the revised (1987)American College of Rheumatology (ACR) criteria or EULAR/ACR (2010) criteria

  • Inadequate response or intolerant to previous therapy with two or more non-biologicdisease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate,administered in an optimal way during at least 3 months; eligible participants mayalso be inadequate responders to a maximum of one biologic DMARD

  • Oral corticosteroids (/= 4 weeks prior to baseline

  • Permitted DMARDs are allowed if at 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 childbearingpotential must agree to use reliable means of contraception as defined by protocol

Exclusion

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or plannedmajor surgery within 6 months following baseline or during long term extension (LTE)period

  • Rheumatic autoimmune disease other than rheumatoid arthritis

  • 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 (intravenous or subcutaneous) 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

  • Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

  • History of severe allergic or anaphylactic reactions to human, humanized or murinemonoclonal 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 IVantibiotics within 4 weeks of screening or oral antibiotics within 2 weeks ofscreening

  • Active Tuberculosis (TB) requiring treatment within the previous 3 years

  • Positive for hepatitis B or hepatitis C

  • Primary or secondary immunodeficiency (history of or currently active)

  • Pregnant or lactating women

  • Neuropathies or other conditions that might interfere with pain evaluation

  • Inadequate hematologic, renal or liver function

Study Design

Total Participants: 57
Study Start date:
January 01, 2014
Estimated Completion Date:
September 30, 2015

Connect with a study center

  • Aalst, 9300
    Belgium

    Site Not Available

  • Assebroek, 8310
    Belgium

    Site Not Available

  • Bonheiden, 2820
    Belgium

    Site Not Available

  • empty

    Bouge, 5004
    Belgium

    Site Not Available

  • Bruxelles, 1020
    Belgium

    Site Not Available

  • Genk, 3600
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • empty

    Gilly, 6060
    Belgium

    Site Not Available

  • Gilly (Charleroi), 6000
    Belgium

    Site Not Available

  • Gosselies, 6041
    Belgium

    Site Not Available

  • Haine-Saint-Paul, 7100
    Belgium

    Site Not Available

  • empty

    Haine-St-Paul, 7100
    Belgium

    Site Not Available

  • empty

    Ixelles, 1050
    Belgium

    Site Not Available

  • empty

    Kortrijk, 8500
    Belgium

    Site Not Available

  • empty

    Liege, 4000
    Belgium

    Site Not Available

  • Liège, 4000
    Belgium

    Site Not Available

  • Roeselare, 8800
    Belgium

    Site Not Available

  • Sijsele, 8340
    Belgium

    Site Not Available

  • empty

    Sijsele-Damme, 8340
    Belgium

    Site Not Available

  • Sint-Niklaas, 9100
    Belgium

    Site Not Available

  • Wilrijk, 2610
    Belgium

    Site Not Available

  • Luxembourg, 2763
    Luxembourg

    Site Not Available

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