[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643440":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":55,"collaborators":57,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":83,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FMT group","EXPERIMENTAL","Participants of this group will take lyophilised oral capsules with faecal microbiota prepared from health donors; previous csDMARDs regimen will continue simutaneously.",[13],"Drug: lyophilised oral capsules with faecal microbiota",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo group","PLACEBO_COMPARATOR","Participants in this group will take placebo capsules with no microbiota inside; previous csDMARDs regimen will continue simutaneously.",[19],"Drug: Placebo capsules",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","lyophilised oral capsules with faecal microbiota","Faecal microbiota is extracted from fresh stool collected from strictly screened health donors with canonical procedure, and then lyophilised and prepared into oral capsule.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo capsules","placebo capsules with the same appearance as FMT capsules but no microbiota inside",[15],[32],{"name":33,"affiliation":5,"role":34},"Lidan Zhao","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","13810700035","zhaolidan@hotmail.com",[41],{"facility":5,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Beijing","Beijing Municipality","100730","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":34,"investigatorFullName":33,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof.",[58],{"name":59,"class":60},"Qingdao Haier Biotech Co., LTD","UNKNOWN","100643440","phase-2-faecal-microbiota-transplantation-in-patients-with-refractory-rheumatoid-arthritis-100643440",false,"NCT07639177","Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis","Efficacy and Safety of Lyophilised Oral Faecal Microbiota Transplantation in Patients With Active Refractory Rheumatoid Arthritis- A Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-65 years with informed consent;\n2. Fulfill the 2010 ACR\u002FEULAR classification criteria for rheumatoid arthritis;\n3. Positive RF or anti-CCP antibody on screening;\n4. Active disease status with swollen joint count(SJC)≥3 and tender joint count(TJC)≥3 and ESR \\>25 mm\u002Fhr or hypersensitive C-reactive protein \\> 10 mg\u002FL;\n5. Having received csDMARDs including but not limited to methotrexate (at a stable dose of 7.5 - 20 mg\u002Fweek) for 3 months or longer prior to screening and willing to continue current regimen for the duration of the study;\n6. Other csDMARDs (e.g. Leflunomide, Iguratimod, Sulfasalazine, Hydroxychloroquine, Tripterygium Wilfordii, etc.) taking before screening with dosage stablized for 3 months or longer are permitted and should continue during the duration of the study;\n7. Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA;\n8. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening;\n9. Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses) ;\n10. Participants with fertility must use a medically effective form of contraception and agree to continue its use during the study or at least 3 monts after the last dose of study intervention.\n11. Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc.\n\nExclusion Criteria:\n\n1. Pregnant, lactating or further fertility requirements\n2. History of any inflammatory rheumatological disorders other than RA;\n3. Having used biologics or small-molecular targeting agents in 6 months prior to screening;\n4. Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening;\n5. Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease;\n6. Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery.\n7. Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis;\n8. Malignancy or history of malignancy;\n\n8\\. Other conditions that investigators consider inappropriate for this study.","ALL","18 Years","65 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"PHASE2","In this 24-week, single center, randomized, double-blind, placebo-controlled study, the efficacy and safety of lyophilised oral fecal microbiota transplantation in patients with active refractory rheumatoid arthritis will be evaluated.",[79],"Rheumatoid Arthritis",[81,82],"Faecal Microbiota Transplantation","Refractory Rheumatoid Arthritis","NOT_YET_RECRUITING","2026-06-05",{"date":86,"type":87},"2026-06-10","ACTUAL",{"date":89,"type":73},"2026-06-15",{"date":91,"type":73},"2028-12-31",{"name":5,"class":6},1]