Rheumatoid Arthritis
Conditions
Interventions
Group 1:Tofacitinib
Group 2:cDMARDs
Sponsors
Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. There has been an informed consent signed with name and date, indicating that the patient (or the legal representative of the patient) has been informed of all relevant aspects of the trial; 2. Patients aged 18 and above; 3. Patients who met the 2010 ACR / EULAR diagnostic criteria with a standard score >=6 / 10; 4. There were active diseases meeting the following two conditions at screening visit and baseline visit: The number of joints with tenderness or pain during exercise >=5 (44 joints in total); The number of swollen joints >=3 (44 joints in total); 5. Patients must meet only one of the following criteria in screening; ESR (Westergren method) > 28 mm / h, or; C-reactive protein (CRP) measured > 8 Symptom duration 16 = weeks without any DMARDs (including Tripterygium wilfordii).
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing women; 2. Hematological indexes were abnormal, including: hemoglobin < 9 g/dL or hematocrit < 30%; leukocyte count < 3.0 x 10^9/L; neutrophil absolute count < 1.2 x 10^9/L; platelet count < 100 x 10^9/L; 3. The estimated GFR calculated by Cockcroft Gault equation is less than 40 ml / min; 4. At the time of screening, AST or ALT exceeded 1.5 times of the upper limit of the normal value, or any uncontrolled laboratory abnormality with clinical significance, which may affect the interpretation of the research data or the participation of patients in the trial; 5. Current or recent patients with uncontrolled clinical history of kidney, liver, blood, gastrointestinal tract, endocrine, metabolism, lung, heart or nervous system diseases; 6. Patients with any other history of rheumatic autoimmune diseases, but excluding secondary Sjogren's syndrome; 7. The prosthesis is is still in situ in patients who have a history of artificial joint infection at any time; 8. Patients with any history of lymphoproliferative diseases, such as Epstein Barr virus (EBV) related lymphoproliferative diseases, have a history of lymphoma or leukemia, or have symptoms and signs indicating that they currently have lymphoproliferative diseases; 9. Patients with a history of recurrent (more than one) herpes zoster, or disseminated (single attack) herpes zoster, or disseminated (single attack) herpes simplex infection; 10. Within 6 months before the first administration of the study drug, there were any patients who needed hospitalization, non gastrointestinal antibacterial treatment, or other infection history with clinical significance determined by the investigator; 11. Within 2 weeks before the first administration of the study drug, there were any infected patients who needed antibacterial treatment; 12. Patients who have had any live vaccine or attenuated vaccine within 6 weeks before the first administration of the study drug, or at any time during the treatment period or within 6 weeks after the discontinuation of the study drug are to receive these vaccines; 13. Any patient who may affect the absorption of oral drugs, such as gastrectomy, clinically significant diabetic gastrointestinal disease, or certain types of obesity surgery such as gastric bypass; 14. Patients with a history of alcohol or drug abuse had less than 6 months of abstinence before taking the drug for the first time; 15.12 lead electrocardiogram (ECG) screening suggests that it may affect the safety of patients, clinically relevant abnormalities and the interpretation of research results; 16. Patients with hereditary immune deficiency disease in first-degree relatives; 17. Patients with malignant lesions or a history of malignant lesions, except for non metastatic basal or squamous cell carcinoma of the skin or cervical carcinoma in situ that have been properly treated or resected; 18. Patients with obvious trauma or surgery within one month of the screening visit; 19. Patients with human immunodeficiency virus (HIV), or hepatitis B virus, or hepatitis C virus infection; 20. According to the judgment of the investigator, there are other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk related to participating in the test or using the research product, or may affect the interpretation of the research results, which may make the patient unsuitable for the test; 21. Patients who have signed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS;HAQ;CRP; | — |
Contacts
Public ContactGuihong Wang
Department of Rheumatology, Anqing Hospital Affiliated to Anhui Medical University
Outcome results
None listed