A new look at rheumatology in China--opportunities and challenges.
Zhan-Guo Li
https://pubmed.ncbi.nlm.nih.gov/25599919Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07045896
Fucoidan Therapy in Adults With Active Rheumatoid Arthritis and Inadequate Response to Conventional DMARDs: a Multicenter Single-arm Open-label Phase 2 Trial
Led by Peking University People's Hospital · Updated on 2026-04-17
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the potential therapeutic effects of fucoidan, an inhibitor of scavenger receptor-A (SR-A), in adults with active rheumatoid arthritis (RA) who have had an inadequate response to conventional treatments. RA is a chronic autoimmune disease marked by joint damage and autoantibody production, and elevated SR-A levels have been linked to disease progression. This multicenter, single-arm, open-label trial aims to provide original clinical data by enrolling 40 patients for a 12-week follow-up period to evaluate clinical symptoms, laboratory markers, and disease activity. Participants will continue their existing conventional RA treatments while taking 2000 mg of oral fucoidan twice daily for 12 weeks. Fucoidan is provided as size-0 gelatin capsules containing 1000 mg of fucoidan powder each. This add-on therapy will be systematically assessed throughout the treatment period to monitor its impact on disease progression and activity. Patients will undergo regular evaluations including clinical assessments and laboratory tests to measure disease activity and response to treatment. The primary outcome is the proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12. Secondary outcomes include remission rates by Disease Activity Score in 28 joints using ESR, changes in clinical disease activity indices, and response rates according to other established RA criteria. Safety and adherence will also be monitored during the study period.
CONDITIONS
Brief Title
Fucoidan in the Treatment of Active Rheumatoid Arthritis
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18-65 years (inclusive) with a minimum weight of 35 kg
- Diagnosis of rheumatoid arthritis meeting the 2010 ACR classification criteria
- Active rheumatoid arthritis with moderate-to-high disease activity (DAS28-ESR >3.2) despite current treatment
- Stable doses of conventional NSAIDs or pain medications for at least 2 weeks before study start and unchanged during study
- Stable oral corticosteroid treatment (≤1.0 mg/kg/day prednisone equivalent) for at least 4 weeks before study start and unchanged during study
- Stable DMARD treatment (methotrexate ≤25 mg/week with folic acid supplementation or leflunomide ≤40 mg/day) for at least 8 weeks and unchanged for 4 weeks before study start
- Negative pregnancy tests for females of childbearing potential at screening
- Use of effective contraception from consent signing through 3 months after last dose for females of childbearing potential and males without vasectomy
- Willingness and ability to comply with study restrictions
- Signed informed consent and understanding of study purpose and procedures
You will not qualify if you...
- Current use of biologic therapy
- Other inflammatory joint diseases or connective tissue diseases
- Significant bone marrow impairment or severe anemia, leukopenia, or thrombocytopenia due to inactive rheumatoid arthritis
- Persistent or severe infections within 3 months prior to enrollment
- Uncontrolled hypertension, diabetes, ischemic heart disease, active inflammatory bowel disease, active peptic ulcers, terminal illnesses, or other high-risk conditions
- Major systemic diseases complicating study participation or results interpretation
- Severe hypoalbuminemia (serum albumin <30 g/L) from liver disease or nephrotic syndrome
- Moderate or severe renal impairment (serum creatinine >133 µmol/L or 1.5 mg/dL)
- Recent or significant drug or alcohol abuse
- Impaired liver function or persistent elevated alanine aminotransferase (>2 times upper limit)
- Pregnant or breastfeeding patients
- Severe immunodeficiency, history of cancer or lymphoproliferative disorders, or total lymphoid irradiation
- Known HIV-positive status
- Positive hepatitis B or C serology
- Participation in other clinical trials or medical research involving investigational drugs or devices
- Active infection requiring antimicrobial therapy within 28 days before study drug
- Body mass index (BMI) <18.5 kg/m² or >30 kg/m²
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 12 weeks continuous treatment
Participants receive oral fucoidan capsules twice daily in addition to their stable conventional rheumatoid arthritis treatment.
Regular visits during the 12 weeks of treatment
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China
Actively Recruiting
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Research Team
L
Liling Xu
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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