TrialBridgeNCT07347860
Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis
Recruiting · Early Phase 1 · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · registry updated 2026-01-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
The primary objective of the study was to evaluate the safety and tolerability of A-319 in patients with active rheumatoid arthritis.
Inclusion
- Age 18-70 years (inclusive), gender unrestricted.
- Meet the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, with a diagnosis of rheumatoid arthritis for at least 24 weeks.
- Patients with rheumatoid arthritis who have previously responded inadequately to at least one csDMARD and who have not responded to 12 weeks of combined treatment with at least one bDMARD or/and tsDMARD with a different mechanism of action in addition to their original csDMARD, such as those with insignificant improvement in swollen/tender joints, physical condition, or disease activity.
- Experiencing at least one of the following clinical manifestations suggestive of moderate to severe RA disease activity:
- \) C-reactive protein-based 28-joint disease activity index (DAS28-CRP) \>3.2 or clinical disease activity index (CDAI) \>10; 2) Clinical manifestations and/or symptoms suggestive of disease activity, including acute inflammatory markers (ESR, CRP) and imaging findings, and joint-related or other symptoms. 5. At the screening and baseline visits, patients must have ≥ 6 tender joints (TJCs) per 68 units and ≥ 4 swollen joints (SJCs) per 66 units.
- \. If the patient is taking oral glucocorticoids, the dose of prednisone or its equivalent must be ≤ 7.5 mg/day and maintained stable for at least 2 weeks before the first dose.
Exclusion
- Subjects with other autoimmune diseases that the investigator considers would not potentially benefit from A-319 treatment; or conditions that interfere with the assessment of joint swelling and pain. 2. Use of abatacept, infliximab, adalimumab, or tocilizumab within 6 weeks prior to the first treatment with the study drug; use of etanercept, anakinra, immune globulin, or blood products within 4 weeks prior to the first treatment with the study drug; or use of a JAK inhibitor (e.g., tofacitinib, baricitinib, or upadacitinib), mycophenolate mofetil, cyclosporine, or iguratimod within 2 weeks prior to the first treatment with the study drug.
- \. Use of B-cell depleting therapy, such as rituximab, within 3 months prior to the first treatment with the study drug; cell counts must have returned to acceptable levels or baseline.
- \. Subjects with any periprosthetic joint infection. 5. Patients with immunodeficiency (defined as immunoglobulin G ≤ 5g/L). 6. History of demyelinating diseases, including, but not limited to, multiple sclerosis, Guillain-Barré syndrome, and neuromyelitis optica (Devic's disease). 7. Laboratory values: Hemoglobin level \< 9.0 g/dL, absolute white blood cell (WBC) count \< 3.0 × 109/L (\< 3000/mm3), or absolute neutrophil count \< 1.2 × 109/L (\< 1200/mm3), or absolute lymphocyte count \< 0.8 × 109/L (\< 800/mm3); thrombocytopenia, defined as a platelet count \< 100 × 109/L (\< 100,000/mm3); age-appropriate estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2, proteinuria ≥ 3+; total bilirubin (T-bili), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) exceeding 1.5 times the upper limit of normal (ULN). 8. Receipt of live or live attenuated vaccines within 30 days prior to first medication use.
- \. Active hepatitis during the screening period, or positive hepatitis B virus surface antigen (HBsAg), or positive hepatitis B virus core antibody (HBcAb) plus hepatitis B virus (HBV) deoxyribonucleic acid (DNA), or positive hepatitis C virus (HCV) antibody plus HCV RNA; history of human immunodeficiency virus (HIV) infection, or positive HIV antibody during the screening period; or positive Treponema pallidum antibody during the screening period.
- \. Chronic active infection or acute infection requiring systemic treatment with antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks prior to screening, or superficial skin infection requiring treatment within 1 week prior to screening (Note: Patients can be rescreened after the infection is resolved). 11. Major surgical procedure (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures within 4 weeks prior to the first dose of study drug, or plans for major surgery during the study.
- \. A history of a major clinical illness (such as circulatory system disorders, endocrine system disorders, nervous system diseases, respiratory system diseases, hematologic diseases, immune system diseases, psychiatric disorders, and metabolic instability) that the investigator believes will pose a risk to the patient's safety, or that may affect safety or efficacy analysis if the disease/symptom worsens during the study. For example: Cardiovascular disease: history of acute myocardial infarction, unstable angina, or severe arrhythmias (multi-source frequent premature ventricular contractions, ventricular tachycardia, or ventricular fibrillation) within 6 months prior to screening; New York Heart Association (NYHA) class III-IV.