A Phase 2 Study of Hemay007 in Patients With Rheumatoid Arthritis

  • STATUS
    Recruiting
  • days left to enroll
    24
  • participants needed
    140
  • sponsor
    Tianjin Hemay Pharmaceutical Co.,Ltd
Updated on 24 March 2022
corticosteroids
methotrexate
rituximab
prednisone
adalimumab
tofacitinib
anakinra
infliximab
steroidal anti-inflammatory drugs
etanercept
hydroxychloroquine
DMARD
sulfasalazine
rheumatism
golimumab
leflunomide
tocilizumab
erythrocyte sedimentation

Summary

This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Hemay007 in Patients with moderate to severe Rheumatoid Arthritis who are on a stable dose of DMARDs.

Description

This study adopts a multi-center, randomized, double-blind clinical study design. Patients with moderate to severe active rheumatoid arthritis who meet the inclusion criteria but do not meet the exclusion criteria will be randomly assigned into the 600 mg QD group, 800 mg QD group, 1200 mg QD group and placebo group at a ratio of 1:1:1:1, with about 35 subjects in each group. Patients in all the groups will be treated with Hemay007 or placebo for 12 weeks, and observed for 4 weeks after the treatment. This study is to evaluate the safety and investigate the efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Hemay007 in Patients with moderate to severe Rheumatoid Arthritis who are on a stable dose of DMARDs.

Details
Condition Rheumatoid Arthritis
Treatment Hemay007 800 mg QD group, Hemay007 1200 mg QD group, Hemay007 600 mg QD group, Hemay007 placebo group
Clinical Study IdentifierNCT05247216
SponsorTianjin Hemay Pharmaceutical Co.,Ltd
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

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 (γ-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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note