Rheumatoid arthritis
Conditions
Interventions
Treatment group:YMN-V112. This study adopts a 3+3 design for dose escalation. Fixed-dose administration will be applied, with divided into three dose groups: low, medium and high, respectively. The st
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Subjects who have signed the written informed consent form (ICF) and are able to complete the study in full compliance with the study protocol. (2) Aged between 18 and 65 years, of either sex. (3) Body weight >= 30 kg. (4) Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA, with a disease duration of >= 6 months. (5) Swollen Joint Count (SJC) >= 6 (based on the 66-joint count) and Tender Joint Count (TJC) >= 6 (based on the 68-joint count) at the screening period; if a joint presents with both swelling and tenderness, it shall be included in both SJC and TJC (excluding prosthetic joints). (6) C-reactive protein (CRP) >= 5 mg/L, or erythrocyte sedimentation rate (ESR) > 28 mm/hr at the screening period. (7) At screening, if the subject is receiving prednisone or an equivalent dose of other corticosteroids, the subject must have been maintained on a stable dose for at least 4 weeks prior to the first dose of study drug, with a prednisone or equivalent dose = 3.2. (11) Subjects with inadequate response to biological agents including tumor necrosis factor-alpha (TNF-a) inhibitors, interleukin-6 (IL-6) inhibitors, Janus kinase (JAK) inhibitors, and anti-CD20 monoclonal antibodies: enrollment is allowed only after a washout period of 5 half-lives of the respective agent, whichever is longer. (12) Subjects with mild fluctuation of disease activity during the screening or washout period may receive paracetamol (acetaminophen) for symptomatic management.
Exclusion criteria
Exclusion criteria: (1) Subjects with previous treatment with erythrocyte membrane preparations or allergy to any component thereof. (2) Subjects with ACR functional class IV, or long-term bedridden/wheelchair-bound status. (3) Subjects with a past or current history of inflammatory joint diseases other than rheumatoid arthritis (e.g., gout, reactive arthritis, psoriatic arthritis, spondyloarthritis, Lyme disease, etc.); or other systemic autoimmune diseases (e.g., systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndromes), excluding patients with Sjögren’s syndrome secondary to rheumatoid arthritis. (4) Subjects with clinically significant, severe and uncontrolled concomitant diseases judged by the investigator, including but not limited to neurological, cardiovascular, renal, hepatic, endocrine or gastrointestinal disorders. (5) Subjects with any congenital or acquired neurological diseases, vascular diseases or systemic diseases that may interfere with efficacy evaluation of the study treatment (especially joint pain and swelling), such as Parkinson’s disease, cerebral palsy, diabetic neuropathy; or those with neuropathy or other painful conditions that may confound pain assessment. (6) Subjects with confirmed malignant tumors or pulmonary infection identified by examinations at or prior to the screening visit; subjects with positive tuberculosis screening results and diagnosed as active tuberculosis by the investigator; subjects with latent tuberculosis who have not received prophylactic treatment per infectious disease specialist advice or have completed less than 4 weeks of treatment before the first study drug administration. (7) Subjects who have received intra-articular corticosteroid therapy within 4 weeks prior to the first dosing. (8) Participation in another interventional clinical trial within 1 month before screening or within 5 half-lives of the investigational product, whichever is longer. (9) Subjects meeting any of the following laboratory abnormalities at screening:Serum creatinine > 1.5 times the upper limit of normal (ULN);ALT or AST > 1.5 × ULN;Platelet (PLT) 1.5 × ULN;Fibrinogen below the lower limit of normal (refer to local laboratory reference ranges). (10) Subjects with active venous thrombosis at screening, or a medical history of deep vein thrombosis/pulmonary embolism deemed to carry a high venous thromboembolism risk by the investigator. (11) Any other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary effectiveness;Exploratory endpoint; | — |
Countries
China
Contacts
Public ContactXuelei Ma
West China Hospital, Sichuan University
Outcome results
None listed