An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

Last updated: November 27, 2023
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Arthritis And Arthritic Pain

Treatment

Tocilizumab

MTX

Placebo Matched to MTX

Clinical Study ID

NCT03155347
YA29359
  • Ages 18-70
  • All Genders

Study Summary

This is a randomized, double-blind, multi-center, parallel-group study to evaluate the efficacy and safety of subcutaneous (SC) tocilizumab (162 milligrams [mg] every 2 weeks [Q2W]) given as monotherapy and in combination with MTX versus MTX given as monotherapy, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current DMARD therapy. The study comprises a 24-week double-blind treatment phase, followed by a 24-week extension phase.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Chinese participants who are located in mainland China with RA of greater than orequal to (>=) 6 months' duration from onset of the disease, diagnosed according to therevised 1987 ACR criteria and receiving treatment on an outpatient basis
  • Participants must have discontinued etanercept (or YiSaiPu) for >= 2 weeks,infliximab, certolizumab, golimumab, abatacept or adalimumab for >= 8 weeks, anakinrafor >= 1 week prior to randomization
  • Have received oral MTX at a stable dose for at least 12 weeks prior to baseline (MTXdose 10 to 25 mg) and experience of failing at least one non-biologic DMARD includingMTX
  • All treatment with non-biological DMARDs except MTX should be withdrawn at least 2weeks prior to baseline (leflunomide for >= 12 weeks or >= 14 days after standardcholestyramine or activated charcoal washout, azathioprine for >= 4 weeks)
  • SJC >= 6 (on the basis of 66 joint counts) and TJC >= 8 (on the basis of 68 jointcounts) at screening and baseline with at least 3 months of treatment with permittedDMARDs
  • Participants must have either high sensitive CRP >= 10 milligrams per liter (mg/L) orESR >=28 millimeters per hour (mm/hr) at screening
  • Oral corticosteroids (<=10 mg/day prednisone or equivalent) and nonsteroidalanti-inflammatory drug (NSAIDs; up to the maximum recommended dose per local standardof care) are permitted if the dose has been stable for at least 4 weeks prior tobaseline
  • All treatment with Chinese traditional medicine and/or herb medicine for RA treatmentshould be withdrawn at least 2 weeks prior to baseline
  • Females of childbearing potential and males with female partners of childbearingpotential may participate only if using a reliable means of contraception as definedby the protocol

Exclusion

Exclusion Criteria:

  • Participants with major surgery or planned major surgery, rheumatic autoimmune diseaseother than RA, and functional class IV (as defined by the ACR Classification ofFunctional Status in RA)
  • Participants with unsuccessful treatment with an anti-tumor necrosis factor (anti-TNF)agent; previous treatment with any cell-depleting therapies including investigationalagents and janus kinase (JAK) inhibitors or any other new agents which haveDMARD/DMARD-like effect; treatment with intravenous (IV) gamma-globulin,plasmapheresis, or Prosorba column; treatment with alkylating agents
  • Intra-articular or parenteral corticosteroids and/or immunization with alive/attenuated vaccine within 4 weeks prior to baseline
  • History of severe allergic or anaphylactic reactions to human, humanized, or murinemonoclonal antibodies
  • Primary or secondary immunodeficiency (history of or currently active)
  • Evidence of serious uncontrolled concomitant diseases and disease states; evidence ofactive malignant disease
  • Participants with abnormal haematological parameters, abnormal renal and hepaticparameters
  • Positive for either hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and/or hepatitis C virus (HCV) antibody

Study Design

Total Participants: 340
Treatment Group(s): 4
Primary Treatment: Tocilizumab
Phase: 3
Study Start date:
August 02, 2017
Estimated Completion Date:
August 08, 2022

Connect with a study center

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, 014010
    China

    Site Not Available

  • Beijing Union Hospital

    Beijing, 100730
    China

    Site Not Available

  • Peking University People's Hospital

    Beijing, 100044
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing City, 100029
    China

    Site Not Available

  • Peking University First Hospital

    Beijing City, 100034
    China

    Site Not Available

  • Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004
    China

    Site Not Available

  • the First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • Guangdong General Hospital

    Guangzhou City, 510080
    China

    Site Not Available

  • The 1st Affiliated Hospital of Harbin Medical University

    Harbin, 150001
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022
    China

    Site Not Available

  • Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, 010050
    China

    Site Not Available

  • The First Hospital of Jiaxing

    Jiaxing, 314001
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, 250012
    China

    Site Not Available

  • The First Affilliated Hospital of Kunming Medical College

    Kunming, 650032
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, 210008
    China

    Site Not Available

  • Pingxiang People Hospital

    Pingxiang City, 337000
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    ShenYang, 110004
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University

    Taiyuan,
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, 300052
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052
    China

    Site Not Available

  • Xinjiang People Hospital

    Urumqi City, 830000
    China

    Site Not Available

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, 450052
    China

    Site Not Available

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