rheumatoid arthritis
Conditions
Interventions
20mg dose group:Single dose study was given20mg, multiple dose study was given20mg, administration period28d
initial efficacy of continuous administration for about 8 weeks
50mg dose group:Single dose study was given50mg, multiple dose study was given50mg, administration period28d
70mg dose group:Single dose study was given70mg, multiple dose study was given70mg, administration period28d
Sponsors
The Third Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (including both ends), no gender limit; 2. The subjects met the 2010 American College of Rheumatology (ACR)/European League of Rheumatology (EULAR) classification criteria, and the ACR functional classification was grade ?-?; 3. At screening, active RA was defined as having at least 6/68 joints that were tender or painful during exercise and at least 4/66 joints that were swollen (Note: Joints that had undergone major surgery, joints that had received intra-articular corticosteroids within 2 weeks before screening, joints that had received intra-articular hyaluronic acid within 2 weeks before screening or within 6 weeks before randomization were not counted in joint tenderness count (TJC) and joint swelling count (SJC)); 4. During screening, erythrocyte sedimentation rate (ESR)>= upper limit of normal (ULN), or C-reactive protein (CRP) > upper limit of normal (ULN); 5. Body mass index [BMI = weight/height square (kg/m^2)] within the range of 18 ~ 30 (including both ends); 6. The subjects (including their partners) have no fertility plan and are willing to use non-hormonal contraception within 6 months from the screening to the completion of the test, and have no sperm or egg donation plan within 6 months after the completion of the test; 7. Subjects have fully understood the study, voluntarily participated in it, and signed written informed consent; 8. The subjects should be able to communicate well with the researchers and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. A known history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis) or known drug allergy to test drug ingredients or similar active drugs; 2. Previous use of any of the following drugs or treatments: (1) Received a JAK inhibitor (including, but not limited to, tofacitinib) or any other similarly structured drug within 7 half-lives prior to the first dose; (2) The use of traditional synthetic disease-modifying antirheumatic drugs (csDMARDs), including but not limited to methotrexate, leflunomide, sulfasalazine, chloroquine/hydroxychloroquine, penicillamine, within 7 half-lives before the first dose; (3) The use of biologic disease-modifying antirheumatic drugs (bDMARDs) within 5 half-lives or within 3 months (whichever is longer) before the first dose, Including but not limited to anti-tumor necrosis factor (TNF) -a antagonists, interleukin (IL) -l antagonists, IL-6 antagonists, anti-CD20 mab and T cell costimulatory molecular inhibitors, etc.); (4) Received any parenteral (e.g., intramuscular, intravenous, etc.) or intra-articular corticosteroids within 4 weeks before the first dose; Or was taking oral corticosteroids with a daily dose of >10 mg prednisone (or equivalent) or was not stable until 4 weeks before randomization or could not continue at the original stable dose during the trial; (5) Current use of nonsteroidal anti-inflammatory drugs, such as acetaminophen or opioids, whose dose did not stabilize within 4 weeks before randomization, or could not continue at the original stable dose during the trial; (6) Received interferon therapy within 4 weeks before the first dose (e.g., roperonin, canergone, Rebetron, Alferon-N, Perenone, Avonex, Betayronone, Dendrozin, paroxysine, Andafen, deanion, focontai, etc.) or use of drugs known to have strong immunosuppressive or immunoregulatory effects (e.g., pavlin, tripterygium wilfords, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine, etc.); (7) Have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines, food or food supplements, such as CYP3A4 inhibitors or inducers, that may affect the drug under test within 4 weeks before the first dose; (8) Live or attenuated live vaccine within 3 months before the first dose or inactivated vaccine within 1 month or live vaccine, attenuated live vaccine or inactivated vaccine during the planned trial; 3. Have a history or evidence of any of the following diseases: (1) Patients with systemic inflammatory diseases other than RA; (2) Infection with viruses, bacteria, fungi, parasites, mycoplasma or chlamydia requiring systematic treatment occurred within 1 month before screening; (3) Patients with a history of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, or patients with a history of herpes zoster or herpes simplex within 2 months before randomization; (4) Have a history of lymphoproliferative disease, or have signs or symptoms that may be lymphoproliferative disease; (5) The patient has a serious hematological disease (e.g., aplastic anemia, myelodysplastic syndrome) or any disease that can cause hemolysis or red blood cell instability, such as malaria and hemolytic anemia, or may affect the absorption, distribution, metabolism and excretion of drugs, or interfere with the evaluation of results as judged by the investigator; (6) Patients with a history of malignant tumors (cured and wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration;Joint tenderness count;Joint swelling count; | — |
Countries
China
Contacts
Public ContactYang Guoping, Zhang Hao
Outcome results
None listed