difficult-to-treat rheumatoid arthritis
Conditions
Interventions
Tofacitinib group:Tofacitinib (Zhengda Tianqing Pharmaceutical Group Co., LTD., specification 5mg/ tablet, approval number: SinopOD H20193281) 5mg once, twice a day, monotherapy or combined with 1 csD
Baricinib group:Baritinib (Eli Lilly, specification 2mg/ tablet, import drug registration number: H20190039) 2mg once a day, monotherapy or combined with one csDMARDs, for 24 weeks.
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Conforming to the 2010 ACR/EULAR RA classification standard [37]; (2) At least one year of treatment according to current treatment standards (standard treatment); (3) The status of D2T-RA can be confirmed only when the following three conditions are met: ? History of treatment failure: =1 b/tsDMARDs with different mechanism of action failed after csDMARD treatment failed (or contraindicated) as suggested by EULAR; ? Satisfy at least one active disease characteristic: DAS28-ESR > 3.2; Signs indicating active RA appear; Inability to gradually reduce the dose of oral glucocorticoids (less than 7.5 mg/day of prednisone or equivalent); Rapid imaging progress (vander Heijde modified Sharp score increased by =5 points in 1 year, with or without signs of active disease); The disease was well controlled as assessed by the above criteria, but RA symptoms leading to decreased quality of life remained; ? Clinical cognition: rheumatologist and/or patients find it difficult to manage symptoms and/or manifestations. Patients meeting the disease status of D2T-RA were included in the D2T-RA group, and other patients were included in the general RA group. Patients and their family members gave informed consent to this study, voluntarily participated in this survey, and signed informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) age 80 years; (2) Incomplete clinical data; (3) Renal insufficiency, defined as glomerular filtration rate < 40 ml/min at screening (calculated by Cockcroft-Gault); (4) Current or chronic infection with hepatitis B or C or hepatic insufficiency, defined as = 1.5 times of ULN (upper limit of normal) at screening level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT); (5) Evidence of active, latent, or inadequately treated mycobacterium tuberculosis infection; (6) Previous history of lymphoproliferative diseases or malignancies; (7) Prednisone acetate (15 mg or methylprednisolone 12 mg) or more combined with immunosuppressant combined with external articular manifestations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| erythrocyte sedimentation rate;C-reactive protein;Aspartate aminotransferase;Number of tenderness joints;Number of swollen joints; | — |
Countries
China
Contacts
Public ContactYu yakun
Lanzhou University Second Hospital
Outcome results
None listed