Fucoidan in the Treatment of Active Rheumatoid Arthritis

NCT ID: NCT07045896

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-07-31

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 randomized, double-blind, placebo-controlled trial, providing original insights into its clinical application. The investigators plan to enroll 38 patients each in the fucoidan treatment group and the control group, 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Fucoidan Add-on Therapy

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

Group Type: EXPERIMENTAL

Fucoidan

Intervention Type: 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

Placebo Add-on Therapy

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

Group Type: PLACEBO_COMPARATOR

Corn starch

Intervention Type: DRUG

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

Interventions

Fucoidan

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

Intervention Type: DRUG

Corn starch

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fanlei Hu

Professor, Department of Rheumatology and Immunology, Peking University People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fanlei Hu

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

Liling Xu

Role: CONTACT

xuliling1079@163.com

0086-18811797572

References

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.

Reference Type: BACKGROUND

PMID: 25599919 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32312978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36307493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37367662 (View on PubMed)

Other Identifiers

2024PHB505-001

Identifier Type: -

Identifier Source: org_study_id