rheumatoid arthritis
Conditions
Interventions
Group 1:20mg dose
Group 2:50mg dose
Group 3:70mg dose
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 65 years, no gender limit; 2. The subjects met the classification standard of American College of Rheumatology or European Rheumatology Union in 2010, and the ACR function was classified as grade I-III; 3. In screening, active RA is defined as at least 6/68 joints with tenderness or pain during exercise and at least 4/66 joints with swelling; 4. When screening, erythrocyte sedimentation rate >= the upper limit of normal value, or C-reactive protein > the upper limit of normal value; 5. The BMI is in the range of 18 ~ 30; 6. Subjects have no family planning within 6 months from screening to completion of the experiment, and are willing to take non-hormonal contraceptive measures. They have no sperm or egg donation plan within 6 months after completion of the experiment; 7. Subjects have fully understood this research, volunteered to participate, and signed a written informed consent form; 8. Subjects can communicate well with researchers, and understand and abide by the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Known history of drug allergy or atopic allergic disease of clinical significance, or known allergy to experimental drug ingredients or similar active drugs; 2. Previous users of any of the following drugs or treatments: (1) Receiving a JAK inhibitor or any other drug of similar structure within 7 half-lives prior to initial dosing; (2) Traditional synthetic antirheumatic drugs had been used within 7 half-lives prior to initial administration; (3) Use of biologically-modified anti-rheumatic drugs within 5 half-lives or 3 months before the first administration; (4) Received any parenteral or intraarticular corticohormones within 4 weeks prior to initial administration;Or are using oral corticosteroids with a daily dose of >10 mg prednisone or the dose was not stabilized until 4 weeks before randomization, or could not be continued at the original stable dose during the trial; (5) Patients who are using non-steroidal anti-inflammatory drugs such as acetaminophen or opioids and the dose has not stabilized within 4 weeks before randomization, or are unwilling to continue taking the original stable dose during the trial; (6) Received interferon therapy or used drugs known to have strong immunosuppressive or immunomodulatory effects within 4 weeks prior to the first administration; (7) Use of any prescription drug, over-the-counter drug, Chinese herb, food or food supplement that may affect the drug under study within 4 weeks prior to the initial dosing; (8) Receive live or attenuated vaccine or inactivated vaccine within 3 months before the first dose or plan to receive live, attenuated or inactivated vaccine during the trial period; 3. History or evidence of any of the following diseases: (1) Patients with other systemic inflammatory diseases except RA; (2) Infected persons with viral, bacterial, fungal, parasitic, mycoplasma or chlamydia infections that require systematic treatment within 1 month prior to screening; (3) Patients with a history of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, or with a history of herpes zoster or disseminated herpes simplex within 2 months prior to randomization; (4) Have a history of lymphoproliferative diseases, or have various signs or symptoms that may be lymphoproliferative diseases; (5) Having a serious hematological disease or any disease that can cause hemolysis or erythrocyte instability, such as malaria, hemolytic anemia, or which, in the judgment of the investigator, may affect the absorption, distribution, metabolism and excretion of drugs, or interfere with the evaluation of results; (6) Patients with a history of malignant tumor; (7) Patients with a history of tuberculosis or high risk of tuberculosis; (8) Patients with Ferty syndrome; (9) Immunocompromised individuals who, according to the investigator, may pose an unacceptable risk to the subject by participating in the study; (10) Patients with compensatory heart failure, unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention in the 3 months before randomization; (11) Patients with respiratory system, liver, kidney, digestive tract, immune, endocrine, metabolic, psychiatric and other diseases or medical history, which researchers judge may affect drug absorption, distribution, metabolism and excretion, or interfere with the evalua
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events;adverse effect;serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| peak time after administration;peak concentration after administration;area under the concentration and time curve;apparent volume of distribution;plasma clearance;elimination rate constant;plasma terminal elimination half-life;mean retention time; | — |
Countries
China
Contacts
Public ContactLiu Yi, Feng Ping
West China Hospital, Sichuan University
Outcome results
None listed