[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596471":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":33,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fucoidan Add-on Therapy","EXPERIMENTAL","On the basis of the original conventional treatment regimen, 2000 mg of fucoidan was administered orally twice a day for 12 weeks.",[13],"Drug: Fucoidan",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Fucoidan","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",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Fanlei Hu","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Liling Xu","CONTACT","0086-18811797572","xuliling1079@163.com",[32],{"facility":5,"status":33,"city":34,"state":20,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"RECRUITING","Beijing","China","CN",{"type":38,"coordinates":39},"Point",[40,41],116.39723,39.9075,{"lat":41,"lon":40},[44],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":45},"xuliing1079@163.com",{"type":24,"investigatorFullName":23,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Professor, Department of Rheumatology and Immunology, Peking University People's Hospital","100596471","fucoidan-in-the-treatment-of-active-rheumatoid-arthritis-100596471",false,"NCT07045896","Fucoidan in the Treatment of 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","Inclusion Criteria:\n\n* Patients aged 18-65 years (inclusive) at screening, regardless of gender, with a minimum weight of 35 kg.\n* Patients meeting the 2010 ACR classification criteria for rheumatoid arthritis.\n* Patients with active rheumatoid arthritis showing moderate-to-high disease activity (DAS28-ESR \\>3.2) despite current treatment.\n* 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.\n* 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\u002Fkg\u002Fday prednisone equivalent for at least 4 weeks prior to the first study drug administration, and remain unchanged during the study period.\n* If receiving DMARDs (methotrexate ≤25 mg\u002Fweek with folic acid supplementation \\[recommended ≥5 mg\u002Fweek\\] or leflunomide ≤40 mg\u002Fday), 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.\n* Female patients of childbearing potential must have negative serum and urine pregnancy test results at screening.\n* 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.\n* Patients must be willing and able to comply with the study restrictions.\n* Patients must sign the informed consent form, understand the purpose and procedures of the study, and be willing to participate in the study.\n\nExclusion Criteria:\n\n* Patients currently receiving biologic therapy.\n* Patients with other inflammatory joint diseases or connective tissue diseases.\n* Patients with significant bone marrow impairment or significant anemia, leukopenia, or thrombocytopenia secondary to inactive rheumatoid arthritis.\n* Patients with persistent or severe infections within 3 months prior to enrollment.\n* 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.\n* 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.\n* Patients with severe hypoalbuminemia (serum albumin \\\u003C30 g\u002FL), such as due to severe liver disease or nephrotic syndrome.\n* Patients with moderate or severe renal impairment, defined as serum creatinine \\>133 μmol\u002FL (or 1.5 mg\u002FdL).\n* Patients with a recent or clinically significant history of drug or alcohol abuse.\n* Patients with impaired liver function or persistent alanine aminotransferase levels \\>2 times the upper limit of normal.\n* Pregnant patients.\n* Breastfeeding patients.\n* Patients with congenital or acquired severe immunodeficiency, a history of cancer or lymphoproliferative disorders, or those who have undergone total lymphoid irradiation.\n* Patients with known HIV-positive status.\n* Patients with known positive serology for hepatitis B or hepatitis C.\n* 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.\n* Patients with any active infection (including chronic or localized infections) requiring antimicrobial therapy within 28 days prior to the first study drug dose.\n* Patients with a body mass index (BMI) \\\u003C18.5 kg\u002Fm² or \\>30 kg\u002Fm².","ALL","18 Years","65 Years",{"count":59,"type":60},40,"ESTIMATED","INTERVENTIONAL",[63],"NA","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.\n\nThis 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.",[66],"Arthritis, Rheumatoid","2026-04-14",{"date":69,"type":70},"2026-04-17","ACTUAL",{"date":72,"type":70},"2026-01-10",{"date":74,"type":60},"2027-07",{"name":5,"class":6},1]