Arthritis, Rheumatoid
Conditions
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.
Interventions
DRUGFucoidan
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
DRUGCorn 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
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | DAS28-ESR remission: DAS28 \<2.6; DAS28-ESR low disease activity: DAS28 ≤3.2 |
| Change from baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Week 12 | 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. |
| Percentage of patients achieving good or moderate EULAR response at Week 12 | 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. |
| Proportion of subjects achieving American College of Rheumatology 50% improvement criteria (ACR50) at Week 12 | 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. |
| Percentage of participants meeting the 2011 ACR/EULAR Boolean remission criteria at Week 12 | 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 |
Contacts
Primary ContactLiling Xu
Outcome results
None listed