Actively Recruiting
Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-01-16
12
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor
I
ITabMed Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary objective of the study was to evaluate the safety and tolerability of A-319 in patients with active rheumatoid arthritis.
CONDITIONS
Official Title
Clinical Study of (A-319) in the Treatment of Active Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-70 years (inclusive), any gender
- Diagnosed with rheumatoid arthritis for at least 24 weeks, meeting 2010 ACR/EULAR criteria
- Inadequate response to at least one csDMARD and 12 weeks of combined bDMARD or tsDMARD therapy with different mechanisms
- Moderate to severe RA disease activity indicated by DAS28-CRP >3.2, CDAI >10, or clinical and imaging signs
- At screening and baseline, at least 6 tender joints and 4 swollen joints
- If using oral glucocorticoids, prednisone dose must be ≤7.5 mg/day and stable for at least 2 weeks prior to first dose
- Voluntarily signed informed consent and able to complete all required visits
You will not qualify if you...
- Other autoimmune diseases interfering with joint assessment or unlikely to benefit from A-319
- Use of abatacept, infliximab, adalimumab, or tocilizumab within 6 weeks before first dose
- Use of etanercept, anakinra, immune globulin, or blood products within 4 weeks before first dose
- Use of JAK inhibitors, mycophenolate mofetil, cyclosporine, or iguratimod within 2 weeks before first dose
- Use of B-cell depleting therapy like rituximab within 3 months before first dose unless cell counts normalized
- Any periprosthetic joint infection
- Immunodeficiency with immunoglobulin G ≤5 g/L
- History of demyelinating diseases such as multiple sclerosis or Guillain-Barré syndrome
- Hemoglobin <9.0 g/dL, WBC <3.0 × 10^9/L, neutrophils <1.2 × 10^9/L, lymphocytes <0.8 × 10^9/L, or platelets <100 × 10^9/L
- eGFR <45 mL/min/1.73 m2, proteinuria ≥3+, or liver enzymes >1.5 times upper limit normal
- Receipt of live or live attenuated vaccines within 30 days before first dose
- Active hepatitis or positive hepatitis B/C markers, HIV infection, or positive syphilis test during screening
- Active or recent infections requiring systemic treatment within 2 weeks before screening
- Major surgery or unhealed wounds within 4 weeks before first dose
- Major illnesses posing safety risk or affecting study outcomes
- Possible active tuberculosis infection
- Malignancy within 5 years prior to screening except certain cured cancers
- History of major organ or stem cell transplant
- Participation in another clinical trial within 4 weeks or 5 half-lives of prior drug
- Recent depression treatment with suicidal thoughts within 6 months
- Pregnancy, breastfeeding, or plans for pregnancy during the study
- Any condition deemed by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Wuhan Union Hospital
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
Q
Qiubai Li Professor, 85726808
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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