Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Joint Injuries
Arthritis And Arthritic Pain
Treatment
Tocilizumab
MTX
Placebo Matched to MTX
Clinical Study ID
Ages 18-70 All Genders
Study Summary
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- All treatment with non-biological DMARDs except MTX should be withdrawn at least 2weeks prior to baseline (leflunomide for 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- All treatment with Chinese traditional medicine and/or herb medicine for RA treatmentshould be withdrawn at least 2 weeks prior to baseline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
Connect with a study center
The First Affiliated Hospital of Baotou Medical College
Baotou, 014010
ChinaSite Not Available
Beijing Union Hospital
Beijing, 100730
ChinaSite Not Available
Peking University People's Hospital
Beijing, 100044
ChinaSite Not Available
China-Japan Friendship Hospital
Beijing City, 100029
ChinaSite Not Available
Peking University First Hospital
Beijing City, 100034
ChinaSite Not Available
Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
ChinaSite Not Available
the First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaSite Not Available
Guangdong General Hospital
Guangzhou, 510080
ChinaSite Not Available
Guangdong General Hospital
Guangzhou City, 510080
ChinaSite Not Available
The 1st Affiliated Hospital of Harbin Medical University
Harbin, 150001
ChinaSite Not Available
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
ChinaSite Not Available
Affiliated Hospital of Inner Mongolia Medical College
Hohhot, 010050
ChinaSite Not Available
The First Hospital of Jiaxing
Jiaxing, 314001
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, 250012
ChinaSite Not Available
The First Affilliated Hospital of Kunming Medical College
Kunming, 650032
ChinaSite Not Available
Jiangsu Province Hospital
Nanjing, 210008
ChinaSite Not Available
Pingxiang People Hospital
Pingxiang City, 337000
ChinaSite Not Available
Shengjing Hospital of China Medical University
ShenYang, 110004
ChinaSite Not Available
The Second Hospital of Shanxi Medical University
Taiyuan,
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin (天津), 300052
ChinaSite Not Available
Xinjiang People Hospital
Urumqi City, 830000
ChinaSite Not Available
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052
ChinaSite Not Available
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