| Eligibility |
Inclusion Criteria:
- Aged between 18 and 75 years old (both ends included, subject to the date of signing
the informed consent form), male or female.
- According to the 1987 American College of Rheumatology (ACR) or 2010 ACR/EULAR
classification diagnostic criteria, the diagnosis was rheumatoid arthritis, and the
course of disease was =12 weeks.
- If rheumatoid arthritis is moderately or severely active, the disease activity during
the 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 (Tender
joints count: TJC) = 6 (based on 68 joint count) (if the same joint has both swelling and
Tenderness, this joint is included in the counts of swollen joints and tender joints).
Joints that have undergone major surgery and joints that have been intraarticularly
injected with corticosteroids or hyaluronic acid within 2 weeks before screening or 6 weeks
before randomization are not counted in TJC (tender joint count) and SJC (swollen joint
count) count.
Erythrocyte sedimentation rate (ESR)>28mm/h or C-reactive protein (CRP) (or hypersensitive
CRP (hsCRP))>1.5 times the upper limit of the normal range (ULN).
- Subjects who have used at least one rheumatism-improving drug (DMARDs) treatment, but
have poor efficacy (drug time =12 weeks, DAS28>3.2) or intolerance (drug use
interrupted 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 dose
must be stabilized for at least 2 weeks before the first administration. And/or oral
corticosteroids (prednisone =10mg/day or equivalent dose), the dose must have been
stabilized for at least 4 weeks before the first dose, and a stable medication regimen
should 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 the
first administration;
Leflunomide: The drug should be stopped for 12 weeks before the first dose, or
cholestyramine should be eluted for 11 days, and the drug should be stopped for 7 days
before 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 the
first 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 the
drug for 10 weeks before the first dose; Tocilizumab, abatizumab: stop the drug for 12
weeks before the first administration; Cell depletion therapy, such as rituximab: stop the
drug for 1 year before the first dose.
Others, such as: JAK inhibitors, such as tofacitinib, need to be stopped for 1 year before
the 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 4
weeks 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 the
medicine for 2 weeks before the first administration;Any other drugs not mentioned: The
drug should be stopped for 4 weeks or more than 5 half-lives before the first
administration, whichever is longer.
- Take medically approved non-drug contraceptive measures (such as drug-free
intrauterine devices, condoms, female sterilization, and male sterilization) during
the entire trial period and at least 3 months after the end of the medication, and no
Pregnancy planner.
- Those who understand, voluntarily sign the informed consent form, and comply with the
requirements 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 who
need to stay in bed/sedentary wheelchair for a long time due to limited joint function
activities.
- Those who have taken gold preparations or penicillamine in the past or during
screening.
- In the past or at the time of screening, there were other inflammatory joint diseases
other than RA (such as: gout, reactive arthritis, psoriatic arthritis,
spondyloarthropathy, etc.). Or other joint diseases that may affect the evaluation of
curative effect (such as: osteoarthritis with obvious joint pain), the investigator
judged that it is not suitable to join the trial.
- Past or at the screening systemic autoimmune diseases (such as systemic lupus
erythematosus, Felty syndrome, scleroderma, primary Sjogren's syndrome, etc., except
for secondary Sjogren's syndrome), or organ-specific For autoimmune diseases (such as
hyperthyroidism, Hashimoto's thyroiditis, etc.), the investigator has judged that it
is not suitable to join this trial.
- Patients with acute myocardial infarction, unstable angina pectoris, stroke, and
cardiac insufficiency (New York Heart Association (NYHA) cardiac function
classification III/IV) within 6 months before screening.
- The cardiovascular, liver, kidney, lung, digestive tract, nervous system and other
serious diseases (such as: poorly controlled severe diabetes, hypertension,
interstitial pneumonia, obstructive Lung disease, bronchospasm, etc.), the
investigator judged that it is not suitable to join the research.
- At the time of screening, the laboratory test (?-interferon release test) was positive
and met any of the following conditions. The investigator judged that the tuberculosis
infection or suspected infection was.
Chest imaging examination showed suspected tuberculosis infection; Active pulmonary
tuberculosis; Those who have had active Mycobacterium tuberculosis infection within 3 years
before screening; People who have been in contact with or have active tuberculosis in the
home environment.
- Active infection (virus, bacteria, fungus, parasite infection) during screening, mild
fungal infection (such as mild nail infection), or severe infection within 6 months
before screening, as judged by the investigator Those who are not suitable to join
this 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 as
multiple sclerosis, optic neuritis, etc.) in the past or during screening, or have
neurological symptoms suggestive of demyelinating diseases.
- Those who have suffered severe trauma, fracture or joint surgery within 4 weeks before
screening, 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 undergo
such surgery during the trial period.
- The laboratory examination meets any of the following conditions, and the investigator
judges 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 before
screening.
- Active hepatitis B (hepatitis B surface antigen (HBsAg) positive, or hepatitis B core
antibody (HBcAb) positive and peripheral blood HBV DNA higher than the local normal
test value), hepatitis C, or syphilis infection during screening.
- People with other primary or secondary immunodeficiencies in the past or at the time
of screening, including patients with a history of HIV infection and positive HIV test
results.
- Those who have participated in other clinical studies within 3 months before
screening.
- Women who are preparing for pregnancy, pregnancy, lactation, or who become pregnant
during the planned trial period.
- The investigator believes that it is not suitable to participate in this trial for
other reasons.
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