a clinical study of tqh3821 tablets in the treatment of treated rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the efficacy and safety of tqh3821 in treated patients with moderate-to-severe active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participate in this study and sign informed consent; * male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent); * the diagnosis meets the rheumatoid arthritis (ra) classification criteria jointly established by the american college of rheumatology (acr) and the european alliance against rheumatism (eular) in 2010, for at least 3 months ; * moderate to severe active ra was defined by the following criteria: joint swelling ≥6 (based on 66 joints), joint tenderness ≥6 (based on 68 joints), disease activity score 28-c-reactive protein (das28-crp) ≥3.2, and crp\>10mg/l or erythrocyte sedimentation rate (esr) \>28mm/h; * at least 12 weeks of treatment with methotrexate (dose 7.5 to 25 mg/ week) and stable dose (7.5 to 25 mg/ week) ≥4 weeks prior to initial administration of the study drug (oral stable dose methotrexate will be continued as background therapy during the trial); * the subjects can attend the study visit on time and complete the visit; exclusion criteria: * 8 weeks before baseline examination, subjects underwent joint surgery or received intraarticular glucocorticoid therapy at the joint sites evaluated in this study; * patients with rheumatoid arthritis with joint functional activity grade ⅳ or confined to a wheelchair or bed; * current or previous inflammatory joint diseases other than ra and other autoimmune venereal diseases; * patients with lung diseases deemed unsuitable for the study by the investigator; * cardiovascular and cerebrovascular abnormalities; * abnormal thyroid function; * subjects with a history or suspected demyelinating disease of the central nervous system; * have any type of active malignant tumor or have a history of malignant tumor; * presence of active mycobacterium tuberculosis (tb) infection or latent tb infection without appropriate treatment; * have any acute or chronic active infectious disease; * there are serious poorly controlled diseases; * people with active hepatitis, or hepatitis b surface antigen (hbsag) positive, hepatitis b core antibody (hbcab) positive + hepatitis b virus (hbv) dna positive, or hepatitis c virus (hcv) antibody-positive; * history of human immunodeficiency virus (hiv) infection, or positive hiv serological results at screening, and positive antibodies to treponema pallidum during screening; * subjects who had suffered a severe trauma, fracture, or surgical procedure within 8 weeks prior to screening, or who were expected to require major surgical procedures during the study period; * female subjects who are pregnant or lactating; * those who received live attenuated vaccine within 28 days before the start of treatment, inactivated vaccine within 7 days, or planned vaccination during the study period; * the subject has any medical condition that may affect oral drug absorption, gastrectomy or gastrointestinal disease of clinical significance.