A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis

Inclusion Criteria:

• Aged between 18 and 75 years old (both ends included, subject to the date of signingthe informed consent form), male or female.
• According to the 1987 American College of Rheumatology (ACR) or 2010 ACR/EULARclassification diagnostic criteria, the diagnosis was rheumatoid arthritis, and thecourse of disease was ≥12 weeks.
• If rheumatoid arthritis is moderately or severely active, the disease activity duringthe screening period and the baseline period must meet the following criteria: Swollen joints count (SJC) ≥ 6 (based on 66 joint count) and tender joints count (Tenderjoints count: TJC) ≥ 6 (based on 68 joint count) (if the same joint has both swelling andTenderness, this joint is included in the counts of swollen joints and tender joints).Joints that have undergone major surgery and joints that have been intraarticularlyinjected with corticosteroids or hyaluronic acid within 2 weeks before screening or 6 weeksbefore randomization are not counted in TJC (tender joint count) and SJC (swollen jointcount) count. Erythrocyte sedimentation rate (ESR)>28mm/h or C-reactive protein (CRP) (or hypersensitiveCRP (hsCRP))>1.5 times the upper limit of the normal range (ULN).
• Subjects who have used at least one rheumatism-improving drug (DMARDs) treatment, buthave poor efficacy (drug time ≥12 weeks, DAS28>3.2) or intolerance (drug useinterrupted due to adverse reactions) By.
• Methotrexate (MTX, 7.5-25 mg/week) has been used continuously for at least 12 weeks,and the dose has been stabilized for at least 4 weeks before the first administration,and a stable medication regimen shall be maintained during the trial period.
• If the subject is taking non-steroidal anti-inflammatory drugs (NSAIDS≤1), the dosemust be stabilized for at least 2 weeks before the first administration. And/or oralcorticosteroids (prednisone ≤10mg/day or equivalent dose), the dose must have beenstabilized for at least 4 weeks before the first dose, and a stable medication regimenshould be maintained during the trial period.
• The time to stop medication before the first dose meets the following criteria: For traditional medicines for improving rheumatism, such as:Sulfasalazine,hydroxychloroquine, cyclosporine, azathioprine drugs: stop the drug for 4 weeks before thefirst administration; Leflunomide: The drug should be stopped for 12 weeks before the first dose, orcholestyramine should be eluted for 11 days, and the drug should be stopped for 7 daysbefore the first dose. Cyclophosphamide: Stop the drug for 8 weeks before the first dose. For biological agents, such as: Anakinra, Etanercept: Stop the drug for 4 weeks before thefirst dose; Adalimumab: stop the drug for 6 weeks before the first dose;Infliximab,golimumab: stop the drug for 8 weeks before the first administration; Certuzumab: stop thedrug for 10 weeks before the first dose; Tocilizumab, abatizumab: stop the drug for 12weeks before the first administration; Cell depletion therapy, such as rituximab: stop thedrug for 1 year before the first dose. Others, such as: JAK inhibitors, such as tofacitinib, need to be stopped for 1 year beforethe first dose; Iguratimod: need to stop the drug for 4 weeks before the first dose;Intra-articular, intramuscular or intravenous injection of steroids: stop the drug for 4weeks before the first dose; Plasma exchange: stop for 12 weeks before the first dose;Chinese medicine, Chinese patent medicine and Chinese medicine single medicine treatment (including tripterygium wilfordii, total glucosides of paeony, sinomenine): stop themedicine for 2 weeks before the first administration;Any other drugs not mentioned: Thedrug should be stopped for 4 weeks or more than 5 half-lives before the firstadministration, whichever is longer.
• Take medically approved non-drug contraceptive measures (such as drug-freeintrauterine devices, condoms, female sterilization, and male sterilization) duringthe entire trial period and at least 3 months after the end of the medication, and noPregnancy planner.
• Those who understand, voluntarily sign the informed consent form, and comply with therequirements of the research plan.

Exclusion Criteria:

• Those who are known to be allergic to any component of hemay007 tablets.
• Those who have received any medical supportive treatments (such as whitening drugs,drugs for anemia (except folic acid), liver-protecting and enzyme-lowering drugs,blood transfusions, etc.) within 2 weeks before screening.
• The joint function classification of rheumatoid arthritis is Grade IV or those whoneed to stay in bed/sedentary wheelchair for a long time due to limited joint functionactivities.
• Those who have taken gold preparations or penicillamine in the past or duringscreening.
• In the past or at the time of screening, there were other inflammatory joint diseasesother than RA (such as: gout, reactive arthritis, psoriatic arthritis,spondyloarthropathy, etc.). Or other joint diseases that may affect the evaluation ofcurative effect (such as: osteoarthritis with obvious joint pain), the investigatorjudged that it is not suitable to join the trial.
• Past or at the screening systemic autoimmune diseases (such as systemic lupuserythematosus, Felty syndrome, scleroderma, primary Sjogren's syndrome, etc., exceptfor secondary Sjogren's syndrome), or organ-specific For autoimmune diseases (such ashyperthyroidism, Hashimoto's thyroiditis, etc.), the investigator has judged that itis not suitable to join this trial.
• Patients with acute myocardial infarction, unstable angina pectoris, stroke, andcardiac insufficiency (New York Heart Association (NYHA) cardiac functionclassification III/IV) within 6 months before screening.
• The cardiovascular, liver, kidney, lung, digestive tract, nervous system and otherserious diseases (such as: poorly controlled severe diabetes, hypertension,interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), theinvestigator judged that it is not suitable to join the research.
• At the time of screening, the laboratory test (γ-interferon release test) was positiveand met any of the following conditions. The investigator judged that the tuberculosisinfection or suspected infection was. Chest imaging examination showed suspected tuberculosis infection; Active pulmonarytuberculosis; Those who have had active Mycobacterium tuberculosis infection within 3 yearsbefore screening; People who have been in contact with or have active tuberculosis in thehome environment.
• Active infection (virus, bacteria, fungus, parasite infection) during screening, mildfungal infection (such as mild nail infection), or severe infection within 6 monthsbefore screening, as judged by the investigator Those who are not suitable to jointhis trial.
• Patients with any type of malignant tumor in the past or at the time of screening.
• Patients who have demyelinating diseases of the central nervous system (such asmultiple sclerosis, optic neuritis, etc.) in the past or during screening, or haveneurological symptoms suggestive of demyelinating diseases.
• Those who have suffered severe trauma, fracture or joint surgery within 4 weeks beforescreening, or are expected to undergo major surgery during the trial period.
• Those who have undergone surgery that may affect drug absorption, distribution,metabolism, and excretion within 3 months before screening, or are expected to undergosuch surgery during the trial period.
• The laboratory examination meets any of the following conditions, and the investigatorjudges that it is not suitable to participate in this trial: Renal function: blood creatinine>1.5×ULN; Liver function: ALT or AST>1.5×ULN, or TBIL>1.5×ULN; Blood routine: white blood cell count (WBC) <3.0×10^9/L, absolute neutrophil count (ANC) <1.5×10^9/L, absolute lymphocyte count (ALC) <0.5×10^9/L, platelet count (PLT) )<100×10^9/L, hemoglobin (HGB)<85g/L; Blood biochemistry: triglyceride>10mmol/L.
• Those who have a history of smoking, alcoholism, or drug abuse within 12 months beforescreening.
• Active hepatitis B (hepatitis B surface antigen (HBsAg) positive, or hepatitis B coreantibody (HBcAb) positive and peripheral blood HBV DNA higher than the local normaltest value), hepatitis C, or syphilis infection during screening.
• People with other primary or secondary immunodeficiencies in the past or at the timeof screening, including patients with a history of HIV infection and positive HIV testresults.
• Those who have participated in other clinical studies within 3 months beforescreening.
• Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnantduring the planned trial period.
• The investigator believes that it is not suitable to participate in this trial forother reasons.