rheumatoid arthritis
Conditions
Interventions
1:Tripterygium wilfordii polyglycoside tablets + Adamu monoclonal antibody
2:Methotrexate tablets + Adamu monoclonal antibody
Sponsors
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low disease activity rate;Clinical remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of pain joints;Rheumatoid factor;C-reactive protein;Anti-cyclic citrullinated peptide antibody;Erythrocyte sedimentation rate;Pain VAS score;Number of swollen joints;Number of swollen joints; | — |
Countries
China
Contacts
Public ContactWukai Ma
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Outcome results
None listed