Fucoidan in the Treatment of Active Rheumatoid Arthritis

Exclusion Criteria

• •Patients currently receiving biologic therapy.
• •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 persistent or severe infections within 3 months prior to enrollment.
• •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 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 a recent or clinically significant history of drug or alcohol abuse.
• •Patients with impaired liver function or persistent alanine aminotransferase levels \>2 times the upper limit of normal.
• •Pregnant patients.
• •Breastfeeding patients.
• •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 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 a body mass index (BMI) \<18.5 kg/m² or \>30 kg/m².