Fucoidan in the Treatment of Active Rheumatoid Arthritis

Ki vehet részt

• Patients aged 18-65 years (inclusive) at screening, regardless of gender, with a minimum weight of 35 kg
• Patients meeting the 2010 ACR classification criteria for rheumatoid arthritis
• Patients with active rheumatoid arthritis showing moderate-to-high disease activity (DAS28-ESR >3.2) despite current treatment
• If receiving conventional NSAIDs or other pain medications, the dose must have been stable for at least 2 weeks prior to the first study drug administration and remain unchanged during the study period
• If taking oral corticosteroids, patients must have been on treatment for at least 4 weeks, with the dose stabilized at an average of ≤1.0 mg/kg/day prednisone equivalent for at least 4 weeks prior to the first study drug administration, and remain unchanged during the study period
• If receiving DMARDs (methotrexate ≤25 mg/week with folic acid supplementation [recommended ≥5 mg/week] or leflunomide ≤40 mg/day), patients must have been on treatment for ≥8 weeks, with the dose stable for at least 4 weeks prior to the first study drug administration, and remain unchanged during the study period
• Female patients of childbearing potential must have negative serum and urine pregnancy test results at screening
• From the time of signing the informed consent form throughout the study and for 3 months after the last dose, female patients of childbearing potential and male patients who have not undergone vasectomy must use effective contraception
• Patients must be willing and able to comply with the study restrictions
• Patients must sign the informed consent form, understand the purpose and procedures of the study, and be willing to participate in the study

Ki nem vehet részt

• Patients currently receiving biologic therapy
• Patients with persistent or severe infections within 3 months prior to enrollment
• Patients enrolled in any other clinical trial involving off-label use of investigational drugs or devices, or enrolled in any other type of medical research
• Patients with any active infection (including chronic or localized infections) requiring antimicrobial therapy within 28 days prior to the first study drug dose
• Patients with other inflammatory joint diseases or connective tissue diseases
• Patients with significant bone marrow impairment or significant anemia, leukopenia, or thrombocytopenia secondary to inactive rheumatoid arthritis
• Patients with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcers, terminal illnesses, or other conditions that, in the investigator's opinion, would pose a risk to the patient's participation in the study
• Patients with clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic diseases that would complicate the implementation of the protocol or interpretation of study results
• Patients with a recent or clinically significant history of drug or alcohol abuse
• Patients with congenital or acquired severe immunodeficiency, a history of cancer or lymphoproliferative disorders, or those who have undergone total lymphoid irradiation
• Patients with known HIV-positive status
• Patients with known positive serology for hepatitis B or hepatitis C
• Patients with severe hypoalbuminemia (serum albumin <30 g/L), such as due to severe liver disease or nephrotic syndrome
• Patients with moderate or severe renal impairment, defined as serum creatinine >133 μmol/L (or 1.5 mg/dL)
• Patients with impaired liver function or persistent alanine aminotransferase levels >2 times the upper limit of normal
• Pregnant patients
• Breastfeeding patients
• Patients with a body mass index (BMI) <18.5 kg/m² or >30 kg/m²