Rheumatoid Arthritis
Conditions
Interventions
A:Keep the dose of tofacitinib unchanged
B:Reduce the dose of tofacitinib to 5mg qd
C:Stop using tofacitinib
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: In the first phase, patients should meet the following criteria: (1) Individuals with full capacity for civil conduct; (2) Patients aged 18 to 70 years; (3) The diagnosis of rheumatoid arthritis conforms to the 2009 ACR / EULAR diagnostic standard; (4) Treatment of active rheumatoid arthritis with tofacitinib 5mg bid; (5) Patients in the study group (M0) were in remission of low disease activity state (DAS28 standard), and maintained remission / low disease activity state (DAS28 standard) for 3 months under the condition of fixed medication; (6) Background drugs, including oral hormone (less than 7.5mg/d prednisone), methotrexate (10-20mg / W), and anti osteoporosis drugs, are allowed to be used, and the dose should be maintained throughout the treatment process (first stage + second stage).
Exclusion criteria
Exclusion criteria: (1) Patients with moderate to high activity in the first stage; (2) Pregnant or lactating women; (3) There are the following abnormalities in blood routine: hemoglobin < 9 g / dL or hematocrit < 30%; leukocyte count < 3.0 x 10^9/L; absolute neutrophil count < 1.2 x 10^9/L; platelet count < 100 x 10^9/L; (4) Current or recent renal dysfunction (GFR < 40 ml / min), liver dysfunction (AST or ALT mroe than 1.5 ULN), history of blood, digestion, endocrine, metabolism, respiration, heart or nervous diseases; (5) Glucocorticoids were administered intramuscularly, intravenously or intraarticular within 4 weeks; (6) History of autoimmune rheumatic diseases other than Sjogren's syndrome; (7) Cancer history (excluding treated non melanoma skin cancer and cervical carcinoma in situ); (8) Infections requiring hospitalization or non oral antimicrobial treatment within 6 months prior to inclusion in the study; (9) Recurrent or transmissible herpes zoster infection, hepatitis B or C virus or HIV, tuberculosis infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28; | — |
Secondary
| Measure | Time frame |
|---|---|
| ESR;CRP;CDAI;SDAI;PRO;HAQ;EQ-5D;SF-36 v2;MOS-SS;FACIT-F;Concise pain index score;Work restrictions, healthcare resource utilization; | — |
Countries
China
Contacts
Public ContactChengde Yang
Department of Rheumatology and Immunology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed