Fucoidan Therapy in Adults With Active Rheumatoid Arthritis and Inadequate Response to Conventional DMARDs: a Multicenter, Single-arm, Open-label, Phase 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Fucoidan (Drug)
结局指标
主要结局
The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.
时间窗: 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.
The proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12.
时间窗: 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.
次要结局
- 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)
- Percentage of patients achieving good or moderate EULAR response at Week 12(at Week 12)
- Proportion of subjects achieving American College of Rheumatology 50% improvement criteria (ACR50) at Week 12(at Week 12)
- Change from baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Week 12(at Week 12)
- Percentage of participants meeting the 2011 ACR/EULAR Boolean remission criteria at Week 12(at Week 12)
- Percentage of patients achieving good or moderate EULAR response at Week 12(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(at Week 12)
- Change from baseline in Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Week 12(at Week 12)
- Proportion of subjects achieving American College of Rheumatology 50% improvement criteria (ACR50) at Week 12(at Week 12)
- Percentage of participants meeting the 2011 ACR/EULAR Boolean remission criteria at Week 12(at Week 12)
研究者
Fanlei Hu
Professor, Department of Rheumatology and Immunology, Peking University People's Hospital
Peking University People's Hospital