Fucoidan in the Treatment of Active Rheumatoid Arthritis

NCT07045896 | Recruiting

• 1 other identifier: 2024PHB505-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.

  The ACR20 criteria for evaluating the condition are: a 20% or greater improvement in the number of tender joints compared to baseline, a 20% or greater improvement in the number of swollen joints, and a 20% or greater improvement in three of the following five core indicators: A) the patient's overall assessment of disease activity, B) the physician's overall assessment of disease activity, C) the patient's assessment of arthritis pain, D) Health Assessment Questionnaire Disability Index (HAQ-DI), and E) C-reactive protein (CRP) for assessing physical function.

  at Week 12

Secondary Outcomes (5)

• Proportion of patients achieving Disease Activity Score in 28 joints using Erythrocyte Sedimentation Rate (DAS28-ESR) remission or low disease activity at Week 12

  at Week 12

• Change from baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Week 12

  at Week 12

• Percentage of patients achieving good or moderate EULAR response at Week 12

  at Week 12

• Proportion of subjects achieving American College of Rheumatology 50% improvement criteria (ACR50) at Week 12

  at Week 12

• Percentage of participants meeting the 2011 ACR/EULAR Boolean remission criteria at Week 12

  at Week 12

Study Arms (1)

Fucoidan Add-on Therapy

EXPERIMENTAL

On the basis of the original conventional treatment regimen, 2000 mg of fucoidan was administered orally twice a day for 12 weeks.

Drug: Fucoidan

Interventions

Fucoidan DRUG

Background Therapy: Continued pre-existing conventional RA treatment at stable doses Intervention: Oral fucoidan Dosage Form: Size-0 gelatin capsules containing 1000mg fucoidan powder Dosage: 2000mg (2 capsules) per dose, twice daily (BID) Duration: 12 weeks continuous treatment

Fucoidan Add-on Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Related Publications (4)

• Li ZG. A new look at rheumatology in China--opportunities and challenges. Nat Rev Rheumatol. 2015 May;11(5):313-7. doi: 10.1038/nrrheum.2014.218. Epub 2015 Jan 20.

  PMID: 25599919 BACKGROUND

• Hu F, Jiang X, Guo C, Li Y, Chen S, Zhang W, Du Y, Wang P, Zheng X, Fang X, Li X, Song J, Xie Y, Huang F, Xue J, Bai M, Jia Y, Liu X, Ren L, Zhang X, Guo J, Pan H, Su Y, Yi H, Ye H, Zuo D, Li J, Wu H, Wang Y, Li R, Liu L, Wang XY, Li Z. Scavenger receptor-A is a biomarker and effector of rheumatoid arthritis: A large-scale multicenter study. Nat Commun. 2020 Apr 20;11(1):1911. doi: 10.1038/s41467-020-15700-3.

  PMID: 32312978 BACKGROUND

• Yeh CW, Shih CJ, Liu TC, Chiou YL. Effects of oligo-fucoidan on the immune response, inflammatory status and pulmonary function in patients with asthma: a randomized, double-blind, placebo-controlled trial. Sci Rep. 2022 Oct 28;12(1):18150. doi: 10.1038/s41598-022-21527-3.

  PMID: 36307493 BACKGROUND

• Konic Ristic A, Ryan S, Attjioui M, O'Connell S, Gibney ER. Effects of an Extract of the Brown Seaweed Ascophylum nodosum on Postprandial Glycaemic Control in Healthy Subjects: A Randomized Controlled Study. Mar Drugs. 2023 May 31;21(6):337. doi: 10.3390/md21060337.

  PMID: 37367662 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fucoidan

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fanlei Hu

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liling Xu

CONTACT

0086-18811797572; xuliling1079@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rheumatology and Immunology, Peking University People's Hospital

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)