Moderately to Severely Active Rheumatoid Arthritis
Conditions
Interventions
Experimental group:MY004567 Tablets
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between ages of 18 and 70 years (inclusive). 2. Diagnosed as rheumatoid arthritis (RA) based on the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria. 3. Confirmed diagnosis of moderately to severely active RA defined as tender joint count (TJC) = 6 and swollen joint count (SJC) = 6 based on the joint count of 68/66 at screening and prior to D1 (See Appendix 1), with erythrocyte sedimentation rate (ESR) > 28 mm/h and/or C-reactive protein (CRP) >10 mg/L at screening. Joints that have undergone major surgical treatment or joints injected with corticosteroids or hyaluronic acid within 6 weeks prior to D1 will not be included in the TJC and SJC. 4. Continuous use of Methotrexate (MTX) for >= 12 weeks and oral stable doses (7.5-20 mg/week) for >= 4 weeks prior to the first dose of study drug to determine that the subject has an inadequate response to MTX. The dose of MTX is required to remain stable throughout the study. 5. Meet the criteria for permitted medications in concomitant therapy, as detailed in Section 5.5. 6. Body mass index (BMI) of 18–30 kg/m^2 (inclusive) at screening. 7. Women of childbearing potential must have a negative blood human chorionic gonadotropin (hCG) pregnancy test at screening; all subjects and their sexual partners agree to take highly effective contraceptive measures during the study and for at least 90 days post-dose (inform in accordance with Appendix 2); male subjects agree not to donate sperms during the study and for 90 days post-dose. 8. Subjects who agree to sign the informed consent form (ICF) and comply with all aspects of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating female subjects. Females of childbearing potential who have had unprotected sexual intercourse with a heterosexual partner within 28 days prior to taking the drug. 2. Hypersensitivity to the study drug or any ingredient in the study drug. 3. Subjects with known immunodeficiency diseases or first-degree relatives (parents, children, and siblings) of patients with hereditary immunodeficiency. 4. Other inflammatory joint diseases or autoimmune diseases (such as gout, psoriatic arthritis, reactive arthritis, spondyloarthritis, systemic lupus erythematosus, ulcerative colitis, mixed connective tissue disease, etc.) other than Sjögren's syndrome secondary to RA and RA at the time of screening or in the past. 5. Those who are immunocompromised and, in the opinion of the investigator, participating in the trial may pose an unacceptable risk to the subject. 6. Prior use of any of the following medications or treatments: a) Use of potent opioids, including (but not limited to): oxycodone, oxymorphone, fentanyl, levophine, buprenorphine, methadone, hydromorphone, and morphine within 4 weeks prior to the first dose of study drug; b) Use of any JAK inhibitor medication within 4 weeks prior to the first dose of study drug; c) Use of other disease-modifying antirheumatic (DMARDs) or biologics other than MTX prior to the first dose of study drug: use of antimalarials (chloroquine, hydroxychloroquine, etc.), sulfasalazine, penicillamine, oral gold preparations, cyclosporine, azathioprine, cyclophosphamide, iratimod, etc., within 4 weeks prior to the first dose of study drug; Use of botanicals (including Tripterygium wilfordii preparation, total glycosides of Paeonia albaeoniae, Sinomenine and other Chinese patent medicines and/or Chinese herbal medicines, etc.) within 4 weeks before the first dose of the study drug; Use of flunomide within 8 weeks prior to the first dose of study drug; Use of TNF-inhibitors (fusion protein classes), TNF-inhibitors (monoclonal antibody classes) or abatacept within 12 weeks, tocilizumab within 10 weeks, rituximab within 24 weeks, or use of other biologics within 5 half-lives prior to the first dose of study drug; d) Received or prepared to receive intra-articular, intramuscular, intravenous, trigger point or tender point, intracapsular or intra-tenothecal glucocorticoid therapy within 4 weeks prior to the first dose of study drug and during the study. 7. Patients who do not respond well to JAK inhibitor therapy (defined as a poor response to treatment for more than 8 weeks). 8. Patients with rheumatoid arthritis joint functional activity grade (see Appendix 3) grade IV. or patients who need to be wheelchair or bedridden. 9. Non-physiological blood loss within 60 days before taking the drug>=200 mL (including trauma, blood collection, and blood donation); or plan to donate blood during the trial or within 30 days of taking the drug. 10. Has a history of lymphoproliferative disease, or has various signs or symptoms suggestive of a lymphoproliferative disorder, including abnormal lymphadenopathy or hepatosplenomegaly. 11. Have had fever and other infectious diseases within 28 days before taking the drug. Subjects with any acute or chronic active infectious illness at screening. 12. Those with a history of recurrent herpes zoster (>=2 times), disseminated herpes zoster or disseminated herpes simplex, or those with a history of herpes zoster or herpes simplex within 2 months before the first dose of s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactZhang Hong
The First Hospital of Jilin University
Outcome results
None listed