Rheumatoid Arthritis
Conditions
Interventions
Intervention group:Mycophenolate Mofetil
Control Group:Placebo
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: a. Male or female aged 18-65 years; b. Weight not less than 40kg; c. Patients with a definite diagnosis of rheumatoid arthritis (RA) who meet the RA diagnostic criteria introduced by ACR in 1987 or ACR\EULAR in 2010; d. Moderate or high disease activity (DAS28-ESR=3.2 or CDAI > 10) e. i After treatment according to EULAR recommendations (unless contraindicated), conventional DMARDs have failed with at least =2 biological/targeted synthetic DMARDs with different mechanisms of action; At least one of the following is present: disease activity is at least moderate; Have signs and/or symptoms suggestive of disease activity; Failure to reduce glucocorticoid therapy; Imaging shows rapid disease progression; Rheumatoid arthritis symptoms lead to decreased quality of life; iii The rheumatologist and/or the patient considers the signs and/or symptoms of the treatment to be problematic f. If taking glucocorticoids, prednisone should be =10mg or a dose equivalent to prednisone and the dose should remain unchanged for at least 28 days; g. No birth plan during the trial period and 3 months after the trial; h. Understand the purpose and procedure of this test, and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: a. Have a history of drug allergy or known intolerance to MMF b. The subject has recently received a live vaccine or plans to use any live vaccine during the study period; c. A history of infection that required hospitalization, parenteral antimicrobial therapy, or was considered clinically significant by the investigator within the 6 months prior to the first use of the study drug, or any history of infection requiring antimicrobial therapy within the 2 weeks prior to the first use of the study drug; d. Prior to and during the study period, patients with serious cardiovascular disease, damage to important organs such as kidney and liver, or serious lesions of blood system and endocrine system (aplastic disorder, hyperthyroid crisis, etc.), history of HIV/AIDS or malignant tumor, or receiving chemotherapy, organ or bone marrow transplantation, active gastric ulcer or bleeding, etc.; e. History of autoimmune disease other than sjogren's syndrome; f. History of intraarticular corticosteroid injection or infusion within 2 weeks prior to the first use of the study drug; g. The subject is infected with hepatitis B or C virus; h. Clinical, radiological, or laboratory evidence of current active tuberculosis in the subject; i. Patients with mental illness; j. ALT, AST more than 1.5 times the upper limit of normal, creatinine more than 1.5mg/dl or 135umol/L; k. WBC<3×109/L, HGB<85g/L, PLT<100×109/L; l. Pregnant women, breastfeeding women and men or women who intend to give birth in the near future; m. A history of heavy alcohol consumption; n. Participants who have participated in clinical trials of other new drugs within three months; o. Other conditions in which the investigator considers the patient unsuitable for admission to the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of ACR20 at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of ACR50/70 at 12 weeks;Response rate of DSA28-ESR&DAS28-CRP at 12/24 weeks;Changes of DAS28-ESR, DAS28-CRP, CDAI and SDAI scores from baseline at weeks 4, 12 and 24;Changes in pain VAS scores from baseline at week 4, 12 and 24; | — |
Countries
China
Contacts
Public ContactYin Su
Peking University People's Hospital
Outcome results
None listed