A multicenter, prospective, observational study to evaluate the efficacy and safety of Tripterygium wilfordii polyglycosides combined with Adamumab in the treatment of rheumatoid arthritis

The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•(1) Male (50-65 years old) or female (50-65 years old); or patients without fertility requirements;
•(2) Meet the RA classification criteria of ACR/EULAR in 2010;
•(3) After treatment with two or more traditional DMARDs (one of which is methotrexate) for 6 months or more, DAS28-ESR 3.2;
•(4) Subjects are ready to start using Geleli (adamumab);
•(5) Obtain informed consent.

•(1) For those who are allergic to other ingredients in experimental drugs or preparations;
•(2) body mass index [BMI] greater than 30.0 x BMI = weight (kg) / height 2 (m) (square of height);
•(3) women who are pregnant or lactating and women who plan to become pregnant are unwilling or do not take adequate contraceptive measures; male patients who are unwilling or do not take adequate contraceptive measures.
•(4) patients with old or active tuberculosis during acute or chronic infection, patients with viral hepatitis B;
•(5) patients with malignant tumors;
•(6) patients with moderate and severe heart failure (Grade 3-4 of the New York Heart Association);
•(7) demyelinating diseases of the central nervous system;
•(8) those diagnosed with other rheumatic immune system diseases, such as systemic erythematous wolves, ankylosing spondylitis, etc.
•(9) active liver disease, or abnormal liver function, AST or ALT 2 times higher than the upper limit of the normal range;
•(10) use of biological / targeted DMARDS; in the past three months;
•(11) long-term history of glucocorticoid use, daily dose equal to prednisone >= 10mg;
•(12) White blood cell count (WBC) < 4.0 x 10^9 / L, platelet count (PLT) < 100 x 10^9 / L, red egg (HGB) < 90g/L.
•(13) those who are unable or unwilling to provide informed consent or are unable to comply with the requirements of the trial;
•(14) owners who are considered by the researchers to be unsuitable to participate in this study.

发起方

The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine