Clinical trial information for patients with moderate and severe rheumatoid arthritis (methotrexate treatment).

▎ the editor's finger is purple (photo: Wikimedia Commons, author: waltfletcher / CC) Background information we are conducting a multicenter, randomized, double-blind, parallel, positive controlled phase III clinical trial to evaluate the safety and efficacy of lzm008 injection and tuozhumab injection (yamero) in patients with moderate to severe active rheumatoid arthritis with poor response to methotrexate.this trial has been approved by the ethics committee, and the scheme design meets the ethical requirements, which will protect your rights and interests in the trial.introduction of experimental drug: the experimental drug in this study is "recombinant humanized anti-human IL-6R monoclonal antibody (lzm008)". In this study, positive drug control was used. Subjects will be randomly assigned to receive test drug (lzm008) or control drug (tochizumab) according to the ratio of 1:1.Design: trial stage: phase III; design type: positive control test; blind method: double-blind; trial scope: domestic multi center (about 40 centers) number of participants: 640 people. Main inclusion criteria: 1. Voluntary enrollment and signing of informed consent; 2. Confirmed moderate or severe active rheumatoid arthritis, course ≥ 6 Before random administration, those who had received oral methotrexate for at least 12 weeks (≥ 7.5 mg / week) and oral stabilizer dose (methotrexate dosage was 7.5-25 mg / week, including the critical value) for at least 4 weeks; 4.men and women aged 18-70 years old.note: the above are part of the main criteria, and the final selection criteria are evaluated by the researchers and subject to the comprehensive physical examination results of the subjects.patients benefit. If you are interested in participating in the study, he or she will preliminarily judge whether you meet the requirements of the study. If so, he or she will introduce the trial face to face and in more detail. After obtaining your consent, he or she will arrange for you to have corresponding examinations, such as blood test, electrocardiogram, imaging examination, etc.if the examination meets the requirements, you will receive medication and follow-up observation.research institutions: Urban Research Center, Beijing University People's Hospital (group leader unit) Huashan Hospital Affiliated to Fudan University (group leader unit) Union Hospital Affiliated to Tongji Medical College, Wuhan Huazhong University of science and technology, Pingxiang people's Hospital, Shanghai Changhai Hospital, the First Affiliated Hospital of Nanning Guangxi Medical University, Xiamen University, Nanjing Gulou Hospital, the First Affiliated Hospital of Xiamen University The Second Xiangya Hospital of Changsha Central South University Urumqi Xinjiang Uygur Autonomous Region People's Hospital Taiyuan Shanxi Medical University Second Hospital Shijiazhuang Hebei Medical University Third Hospital Hefei Anhui Provincial Hospital Hefei First Affiliated Hospital Hefei Anhui Medical University First Affiliated Hospital Bengbu Bengbu Medical College Shanghai Guanghua integrated Chinese and Western Medicine Hospital Harbin Medical University First Affiliated Hospital Hospital Hohhot Affiliated Hospital of Inner Mongolia Medical University Nanchang Jiangxi people's Hospital Changchun Jilin University China Japan Friendship Hospital Nantong Nantong University Affiliated Hospital Beijing University Shougang Hospital Chongqing Third Military Medical University First Affiliated Hospital Jiujiang Jiujiang first hospital Jieyang Jieyang people's hospital Zhengzhou University First Affiliated Hospital The First Affiliated Hospital of Kunming Medical University Jinan Shandong University Qilu Hospital Tianjin Tianjin First Central Hospital Baotou First Affiliated Hospital of Inner Mongolia University of science and technology Hospital Linyi Linyi people's Hospital Jining Jining first hospital Taiyuan Shanxi Medical University First Hospital Guangzhou Southern Medical University south hospital Shijiazhuang Hebei People's Hospital Changzhou First People's Hospital Hangzhou Zhejiang University Medical School Second Affiliated Hospital welcome to pay attention to our 400-6759-099 hotline working hours Monday Friday 9: 00-18:00 help you quickly find the right new drug clinical trial opportunity, fill in the initial screening information（