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Rheumatoid arthritis is most of the rheumatic immune system diseases, in the past was considered to be immortal cancer, treatment is difficult and suffering from diseases, but in recent decades, with the development of medicine and the study of pathogenesis, new drugs continue to invent, especially the advent of targeted drugs, greatly improving the prognosis of rheumatoid arthritis, in general, as long as the formal treatment is taken, in the early and middle stages of the disease joints without serious deformation and disability, after long-term standardized system treatment, Is completely able to control the condition of rheumatoid arthritis, to achieve long-term clinical remission, currently for such diseases, for patients who want to participate in clinical trials, the top three hospitals specially carry out this clinical free drug, and now openly recruit subjects.
【Drug name】TJ003234 injection
【Indications】Rheumatoid arthritis
【Purpose of the test】
1) Evaluate the safety and tolerability of TJ003234 injection in patients with RA.
2) Evaluate the pharmacokinetic characteristics of TJ003234 injection in patients with RA, evaluate the immunogenicity of TJ003234 injection in patients with RA, and explore the clinical efficacy of TJ003234 and the biomarkers related to efficacy.
(Publicity Platform)
【Main Selection Criteria】
1. Age: 18 to 70 years old (including 18 and 70 years old), gender is not limited.
2. According to the 2010 ACR/EULAR standard, at least 6 months before screening, being diagnosed with rheumatoid arthritis.
3. Single dose: the number of tenderness and swelling in 28 joints of the whole body was assessed and the DAS28 score ≤ 3.2; multiple doses: the number of tenderness and swelling in 28 joints of the whole body was evaluated and the DAS28 score was ≤ 5.1 and the > 3.2
4. One or more standard therapies are permitted, but the start time should be no later than the 12 weeks (84 days) before the randomization and the dose is stable within the 4 weeks (28 days) before the randomization [the combination of methotrexate (MTX) and leflunomide is not allowed within the first 4 weeks (28 days) of the randomization].
5. Subjects are willing to participate in this study and voluntarily sign an informed consent form.
【Main Exclusion Conditions】
1. Employees of clinical research centers with potential conflicts of interest or any other research executives and their immediate family members.
2. If the subject has an existing disease that has previous and/or current clinical significance and has not been stable in the 3 months before enrollment, or an acute disease, a planned medical/surgical procedure, or an injury within 2 weeks before enrollment, the above situation is judged by the researcher to believe that participating in the study may put the subject at corresponding risk, or may interfere with the evaluation of the research drug or confuse the interpretation of the research results, or affect the patient's ability to participate in the study independently.
3. Patients who have previously used other biological agents (e.g., adalimumab, etanercept, infliximab, etc.) or small molecule targeted preparations (e.g., tofatinib, etc.) for the treatment of rheumatoid arthritis.
4. Subjects had used the following non-biological drugs for the treatment of RA in the first 28 days of randomization: tacrolimus, cyclosporine, ellamod, cyclophosphamide, azathioprine, minocycline, imidazolybine, triptolide, paeonia vulgare and other proprietary Chinese medicines, Chinese herbal medicines for the treatment of rheumatoid arthritis patients.
5. Have received any of the following: have used any GM-CSF-related drugs in the current or previous 4 weeks, and have used proprietary Chinese medicines, Chinese herbal medicines, emergency (PRN) over-the-counter anti-inflammatory drugs, and topical drugs including nonsteroidal anti-inflammatory drugs (NSAIDs) for treatment within 2 weeks (14 days) before signing the ICF.
【Location of the main research center (the specific start-up situation is subject to the later consultation)】
Anhui, Beijing, Henan, Jiangsu, Inner Mongolia, Shanghai
Participating in clinical trials can receive free treatment for new therapies, and patients interested in participating in this clinical trial can consult a medical companion.
Note: Whether you can finally join the group needs to be determined by the doctor.