Fucoidan in the Treatment of Active Rheumatoid Arthritis
ConditionArthritis, Rheumatoid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Fucoidan
DrugBackground 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Fucoidan Add-on TherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
at Week 12Secondary outcomes
1
Proportion of patients achieving Disease Activity Score in 28 joints using Erythrocyte Sedimentation Rate (DAS28-ESR) remission or low disease activity at Week 12
DAS28-ESR remission: DAS28 \<2.6; DAS28-ESR low disease activity: DAS28 ≤3.2
Time frame
at Week 122
Change from baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Week 12
CDAI and SDAI indices assess rheumatoid arthritis disease activity through tender/swollen 28-joint counts, patient and physician global assessments (0-10 cm VAS), with SDAI additionally incorporating C-reactive protein (CRP) levels.
Time frame
at Week 123
Percentage of patients achieving good or moderate EULAR response at Week 12
A good response is defined as DAS28-ESR ≤ 3.2, with a decrease of more than 1.2 from baseline; a moderate response is defined as meeting one of the following criteria: DAS28-ESR ≤ 3.2, with a decrease of more than 0.6 and no more than 1.2 from baseline; 3.2 \<DAS28-ESR ≤ 5.1, with a decrease of more than 0.6 from baseline; DAS28-ESR\> 5.1, with a decrease of more than 1.2 from baseline.
Time frame
at Week 124
Proportion of subjects achieving American College of Rheumatology 50% improvement criteria (ACR50) at Week 12
The evaluation is based on: a 50% to 70% or greater improvement in the number of tender joints compared to baseline; a 50% to 70% or greater improvement in the number of swollen joints; and a 50% to 70% or greater improvement in three of the remaining five core indicators: the patient's overall assessment of disease activity, the physician's overall assessment of disease activity, the patient's assessment of arthritis pain, and the Health Assessment Questionnaire Disability Index (HAQ-DI) and C-reactive protein (CRP) for assessing physical function.
Time frame
at Week 12Sponsors and contacts
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Source ClinicalTrials.gov