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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
Peking University People's Hospital
Beijing, China
RECRUITINGThe 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 12
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 12
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 12
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 12
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 12
Percentage of participants meeting the 2011 ACR/EULAR Boolean remission criteria at Week 12
he simplified definition of ACR/EULAR remission criteria in 2011 was: Tender Joint Count \<1; Swollen Joint Coun \<1; overall disease activity assessment in ACR/EULAR patients \<1; CRP \<1mg/L
Time frame: at Week 12
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