Actively Recruiting
Fucoidan in the Treatment of Active Rheumatoid Arthritis
Led by Peking University People's Hospital · Updated on 2026-04-17
40
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint destruction and autoantibody production. Scavenger receptor-A (SR-A), a pattern recognition receptor primarily expressed on myeloid-derived cells, is significantly elevated in the serum of RA patients. Genetic knockout of SR-A completely protects mice from collagen-induced arthritis (CIA). As an SR-A inhibitor, fucoidan markedly suppresses the progression of CIA in mice. Given the potential role of SR-A in RA pathogenesis, the investigators hypothesize that fucoidan may exert therapeutic effects in RA by specifically targeting human SR-A. This study aims to investigate the efficacy of fucoidan in RA treatment through a multicenter, single-arm, open-label trial, providing original insights into its clinical application. The investigators plan to enroll 40 patients with a 12-week follow-up period. Clinical manifestations, laboratory parameters, and disease activity will be systematically evaluated to assess therapeutic outcomes. The findings will provide evidence-based medical data for RA treatment strategies.
CONDITIONS
Official Title
Fucoidan in the Treatment of Active Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 using conventional NSAIDs or other pain medications, the dose must be stable for at least 2 weeks before starting the study and remain unchanged during the study
- If taking oral corticosteroids, treatment must be stable for at least 4 weeks at a dose of ≤1.0 mg/kg/day prednisone equivalent before starting the study and remain unchanged during the study
- If receiving DMARDs (methotrexate ≤25 mg/week with folic acid supplementation or leflunomide ≤40 mg/day), patients must have been on treatment for at least 8 weeks with stable doses for at least 4 weeks before starting the study and remain unchanged during the study
- Female patients of childbearing potential must have negative pregnancy tests at screening
- Female patients of childbearing potential and male patients without vasectomy must use effective contraception from consent signing through 3 months after the last dose
- Patients must be willing and able to comply with study restrictions
- Patients must sign informed consent, understand the study purpose and procedures, and agree to participate
You will not qualify if you...
- Patients currently receiving biologic therapy
- Patients with other inflammatory joint or connective tissue diseases
- Patients with significant bone marrow problems or significant anemia, leukopenia, or thrombocytopenia due to inactive rheumatoid arthritis
- Patients with persistent or severe infections within 3 months before enrollment
- Patients with uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcers, terminal illnesses, or other conditions posing risk to study participation
- Patients with major cardiovascular, liver, neurological, endocrine, or systemic diseases complicating study or result interpretation
- Patients with severe hypoalbuminemia (serum albumin <30 g/L) due to severe liver disease or nephrotic syndrome
- Patients with moderate or severe kidney impairment (serum creatinine >133 µmol/L or 1.5 mg/dL)
- Patients with recent or significant history of drug or alcohol abuse
- Patients with impaired liver function or persistent alanine aminotransferase levels >2 times the upper normal limit
- Pregnant or breastfeeding patients
- Patients with severe immunodeficiency, history of cancer or lymphoproliferative disorders, or after total lymphoid irradiation
- Patients with known HIV-positive status
- Patients with positive hepatitis B or C serology
- Patients enrolled in other clinical trials of investigational drugs or medical research
- Patients with any active infection requiring antimicrobial therapy within 28 days before first study drug dose
- Patients with body mass index (BMI) <18.5 or >30 kg/m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
Research Team
L
Liling Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here