Fucoidan for active rheumatoid arthritis

Fucoidan Therapy in Adults With Active Rheumatoid Arthritis and Inadequate Response to Conventional DMARDs: a Multicenter, Single-arm, Open-label, Phase 2 Trial

This trial will test whether fucoidan, a seaweed-derived SR-A inhibitor, can reduce disease activity in adults (18–65) with active rheumatoid arthritis who have moderate-to-high disease activity despite current treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT07045896 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label clinical trial enrolling 40 patients with active rheumatoid arthritis to receive fucoidan and be followed for 12 weeks. Participants must meet the 2010 ACR classification criteria and have DAS28-ESR >3.2 despite stable background therapy. Clinical signs and symptoms, laboratory markers, and standardized disease-activity scores will be measured at baseline and during follow-up to track changes over time. The trial is intended to provide initial clinical data on the safety and potential efficacy of targeting SR-A with fucoidan.

Who should consider this trial

Good fit: Adults aged 18–65 years meeting the 2010 ACR criteria for RA with moderate-to-high disease activity (DAS28-ESR >3.2), body weight ≥35 kg, and on stable doses of permitted background medications are ideal candidates.

Not a fit: Patients with only mild disease activity, unstable or recently changed RA medications, or major comorbid conditions are less likely to benefit from this small, early open-label trial.

Why it matters

Potential benefit: If successful, fucoidan could reduce RA disease activity and improve symptoms for patients who do not fully respond to current therapies.

How similar studies have performed: Preclinical studies showed that fucoidan suppresses collagen-induced arthritis in mice and SR-A knockout protected mice from disease, but human clinical data are currently very limited.

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.

Where this trial is running

Beijing

• Peking University People's Hospital — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Fanlei Hu — Peking University People's Hospital
• Study coordinator: Liling Xu

Conditions Arthritis, Rheumatoid