Rheumatoid Arthritis
Conditions
Interventions
double drug group:Iguratimod combined with Tofacitinib
single drug group:Tofacitinib
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Complete the aforementioned 24-week randomized controlled observation, and can tolerate existing therapeutic drugs; 2. Good clinical efficacy (generally DAS28-ESR < 3.2, DAS28-ESR < 5.1 in patients with previous refractory RA); 3. Understand the purpose of this trial, cooperate with trial follow-up and drug adjustment plan, and voluntarily sign a written informed consent; 4. Take the test drug on time and regularly; 5. Have no new important organ lesions.
Exclusion criteria
Exclusion criteria: 1. Have a history of allergy to the relevant test drugs; 2. The subject has recently received live vaccines, or plans to use any live vaccines during the study; 3. Before screening, patients with severe cardiovascular disease, kidney, liver and other important organ damage, severe blood system, endocrine system disease (aplastic anemia, hyperthyroid crisis, etc.), HIV/AIDS or history of malignant tumor, or receiving radiotherapy and chemotherapy, organ or bone marrow transplantation, other connective tissue diseases (systemic lupus erythematosus, dermatomyositis), etc. need to be excluded; RA secondary to Sjogren's syndrome is allowed to enter the group; 4. Patients with high-risk lungs: (1) Chest CT/TB-SPOT within 6 months suggests pulmonary tuberculosis and needs to be excluded; (2) Those with nodules found on lung CT, those with diameter > 5mm need to be excluded. Patients with a diameter 50%, CT and MRI should be re-examined at baseline, 12 weeks, 24 weeks, 48 weeks, and 96 weeks. Pulmonary function, six-minute walking distance; 5. ALT and AST exceed 1.5 times the upper limit of normal, and creatinine exceeds 1.5mg/dL or 135umol/L; 6. WBC < 3 x 10^9/L, HGB < 85 g/L, PLT < 100 x 10^9/L; 7. Pregnant women, lactating women and men or women who are planning to conceive in the near future; 8. Those with a history of heavy drinking; 9. Mental patients; 10. Those who have participated in clinical trials of other new drugs within three months; 11. Other conditions in which the patient was deemed unsuitable for entry into the trial by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The ACR20, ACR50 and ACR70 response rates between the two groups;The DAS28-ESR response rate between the two groups;the proportion of people who reach DAS28-ESR<=3.2 in the two groups;SDAI index and SDAI remission ratio (SDAI<=3.3) between the two ;CDAI index and CDAI remission ratio (CDAI<=2.8) between the two groups;the rate of Boolean remission between the two groups;the recovery of joint physical function (HAQ score) between the two groups;The overall assessment of the disease (PtGA) and the physician's overall assessment of the disease (PhGA) between the two groups;Ratios of patients with reduced medication in both groups;The disease activity of the two groups of patients with reduced medication;Overall disease activity, clinical remission duration and recurrence rate in different drug dose groups;Incidence and magnitude of adverse events in both groups;Drug retention rates in the two groups;Efficacy and safety analysis of subgroups with different baseline clinical characteristics and disease activity; | — |
Primary
| Measure | Time frame |
|---|---|
| the clinical remission rate of the two groups, the proportion of patients reaching DAS28<2.6;the proportion of people who reach DAS28-ESR<=2.6 in the two groups; | — |
Countries
China
Contacts
Public ContactQiang Shu
Qilu Hospital of Shandong University
Outcome results
None listed