[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656622":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":43,"overallOfficials":53,"centralContacts":57,"locations":43,"responsibleParty":66,"collaborators":69,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":43,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":43,"enrollmentInfo":83,"targetDuration":86,"studyType":87,"phases":43,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":99,"whyStopped":43,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":43},{"fullName":5,"class":6},"First Affiliated Hospital, Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Net Clinical Benefit at Week 52","Percentage of participants achieving net clinical benefit at Week 52. Net clinical benefit is defined as steroid-free clinical remission at Week 52 without any serious infection, discontinuation of the index advanced therapy due to an adverse event, IBD-related hospitalization, or IBD-related surgery during follow-up. Steroid-free clinical remission is defined as a partial Mayo score ≤2 with no individual subscore \\>1 for ulcerative colitis, or a Harvey-Bradshaw Index ≤4 for Crohn disease, with no systemic corticosteroid use for at least 4 weeks before the Week 52 assessment. Participants with IBD-unclassified will be assessed according to the predominant UC- or CD-like clinical phenotype.","52 Weeks",[14,18,22,25,29,32,36,40],{"measure":15,"description":16,"timeFrame":17},"Steroid-Free Clinical Remission at Week 26","Percentage of participants achieving steroid-free clinical remission at Week 26. Remission is defined as a partial Mayo score ≤2 with no individual subscore \\>1 for ulcerative colitis, or a Harvey-Bradshaw Index ≤4 for Crohn disease, with no systemic corticosteroid use for at least 4 weeks before assessment.","26 Weeks",{"measure":19,"description":20,"timeFrame":21},"Steroid-Free Clinical Remission at Week 52","Percentage of participants achieving steroid-free clinical remission at Week 52, using the same disease-specific definitions as for the Week 26 assessment.","52 weeks",{"measure":23,"description":24,"timeFrame":21},"Advanced Therapy Persistence at Week 52","Percentage of participants who remain on the advanced therapy initiated at baseline at Week 52 without permanent discontinuation because of lack of effectiveness, adverse events, or patient preference. Dose escalation, interval shortening, or re-induction will not be considered treatment discontinuation.",{"measure":26,"description":27,"timeFrame":28},"Incidence of Serious Infection","Percentage of participants experiencing at least one serious infection, defined as an infection requiring hospitalization, intravenous antimicrobial treatment, being life-threatening, resulting in interruption of advanced therapy, or otherwise meeting criteria for a serious adverse event.","From Baseline Through Week 52",{"measure":30,"description":31,"timeFrame":28},"Incidence of IBD-Related Hospitalization","Percentage of participants experiencing at least one IBD-related hospitalization during follow-up, including hospitalization related to active IBD, disease complications, infection, intestinal obstruction, bleeding, malnutrition, treatment-related adverse events, or preparation for IBD-related surgery.",{"measure":33,"description":34,"timeFrame":35},"Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 26","The Inflammatory Bowel Disease (IBD) Frailty Score is a 28-item IBD-specific frailty assessment. Each item is scored 0 or 1, yielding a total score ranging from 0 to 28. Higher scores indicate greater frailty burden and therefore a worse outcome. A total score of ≥4 has been used to classify participants as frail. Change from baseline will be calculated as the Week 26 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.","Baseline and Week 26",{"measure":37,"description":38,"timeFrame":39},"Change From Baseline in Inflammatory Bowel Disease Frailty Score at Week 52","The Inflammatory Bowel Disease (IBD) Frailty Score is a 28-item IBD-specific frailty assessment. Each item is scored 0 or 1, yielding a total score ranging from 0 to 28. Higher scores indicate greater frailty burden and therefore a worse outcome. A total score of ≥4 has been used to classify participants as frail. Change from baseline will be calculated as the Week 52 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.","Baseline and Week 52",{"measure":41,"description":42,"timeFrame":39},"Change From Baseline in Clinical Frailty Scale Score at Week 52","The Clinical Frailty Scale is a clinician-rated global frailty measure ranging from 1 to 9, where 1 represents very fit and 9 represents terminally ill. Higher scores indicate greater frailty and therefore a worse outcome. Change from baseline will be calculated as the Week 52 score minus the baseline score; negative values indicate improvement and positive values indicate worsening.",null,{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":45,"timePerspective":46,"maskingInfo":43},"COHORT","PROSPECTIVE","Older adults with inflammatory bowel disease (IBD) represent a clinically heterogeneous population. Chronological age alone may not adequately reflect physiological reserve, immune competence, frailty, or vulnerability to treatment-related adverse outcomes. Immunosenescence, characterized by age-related changes in immune cell composition and chronic low-grade inflammation, may contribute to differences in both treatment effectiveness and safety among older adults receiving advanced therapies. However, prospective evidence linking clinically accessible markers of immune aging to treatment outcomes in IBD remains limited.\n\nThis prospective, multicenter observational cohort study will evaluate older adults with IBD who initiate a new advanced therapy as part of routine clinical care. Treatment selection and subsequent treatment modifications will remain entirely at the discretion of the treating clinicians and participants. The study will characterize participants using complementary domains including immune-aging markers, frailty, nutritional status, comorbidity and polypharmacy, inflammatory disease activity, and treatment exposure. Candidate immune-aging measures include the CD4\u002FCD8 ratio, lymphocyte measures, interleukin-6, neutrophil-to-lymphocyte ratio, and other routinely available inflammatory and nutritional biomarkers.\n\nThe primary analytical objective is to determine whether baseline immunosenescence and frailty phenotypes are associated with the overall balance of effectiveness and safety after initiation of advanced therapy. The study will also assess whether these measures provide prognostic information beyond conventional clinical factors such as age, disease activity, comorbidity burden, and treatment type. Additional analyses will explore heterogeneity across different mechanisms of advanced therapy, relationships between immune aging, frailty, and nutritional status, and differences between elderly-onset IBD and IBD diagnosed earlier in life but treated during older age.\n\nThe study is intended to establish a clinically applicable framework for risk stratification in older adults with IBD and to provide prospective data for future studies of individualized treatment strategies based on biological aging and vulnerability rather than chronological age alone.","Adults aged 60 years or older with Crohn disease, ulcerative colitis, or IBD-unclassified who are initiating a new advanced therapy as part of routine clinical care at participating tertiary IBD centers. Participants will be enrolled prospectively and followed to evaluate immunosenescence, frailty, treatment effectiveness, safety, and other clinical outcomes. Treatment selection is determined by the treating clinician and is not assigned by the study.",[50],{"label":51,"type":43,"description":52,"interventionNames":43},"Older Adults With IBD Initiating Advanced Therapy","Adults aged 60 years or older with Crohn disease, ulcerative colitis, or IBD-unclassified who are initiating a new advanced therapy as part of routine clinical care. Advanced therapies of interest include vedolizumab, ustekinumab, anti-TNF agents, JAK inhibitors, S1P receptor modulators, and other approved or clinically available advanced therapies. Treatment selection, dosing, optimization, switching, and discontinuation are determined by the treating clinician and are not assigned by the study. Participants will be followed prospectively to evaluate treatment effectiveness, safety, frailty, immunosenescence-related characteristics, and other clinical outcomes.",[54],{"name":55,"affiliation":5,"role":56},"Yun Qiu, MD, PhD","PRINCIPAL_INVESTIGATOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":43,"email":61},"CONTACT","+8613544476809","qyun@mail2.sysu.edu.cn",{"name":63,"role":59,"phone":64,"phoneExt":43,"email":65},"Yingfan Zhang, BSc","+8613342847850","zhyingf3@mail.sysu.edu.cn",{"type":56,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Yun Qiu","Associate Professor of Gastroenterology",[70,72],{"name":71,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University",{"name":73,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine","100656622","immune-aging-and-advanced-therapy-outcomes-in-older-adults-with-ibd-100656622",false,"NCT07828886","Immune Aging and Advanced Therapy Outcomes in Older Adults With IBD","Immunosenescence Phenotypes and Net Clinical Benefit of Advanced Therapies in Older Adults With Inflammatory Bowel Disease: A Prospective Multicenter Observational Cohort Study","Inclusion Criteria:\n\nAge 60 years or older. Confirmed diagnosis of Crohn disease, ulcerative colitis, or inflammatory bowel disease-unclassified.\n\nPlanned initiation of a new advanced therapy, or initiation of the new advanced therapy within 4 weeks before enrollment.\n\nActive inflammatory bowel disease or another clinically documented indication for treatment escalation.\n\nAvailability of the core baseline clinical and laboratory data required for the study.\n\nExpected ability to complete at least 52 weeks of follow-up. Ability to provide written informed consent, or consent provided by a legally authorized representative when applicable.\n\nExclusion Criteria:\n\nUncertain diagnosis of inflammatory bowel disease or an alternative diagnosis that may mimic inflammatory bowel disease.\n\nActive severe infection at enrollment, including sepsis, active tuberculosis, uncontrolled viral hepatitis, cytomegalovirus disease, or another serious opportunistic infection.\n\nSignificant acute infection within 4 weeks before enrollment that, in the investigator's judgment, could substantially affect baseline immune-aging measurements or treatment safety assessment.\n\nActive malignancy or recent systemic anticancer treatment, except for adequately treated low-risk malignancies as permitted by the study protocol.\n\nSevere non-IBD-related immunodeficiency. End-stage disease or another condition associated with an expected life expectancy of less than 12 months.\n\nInability to obtain the core baseline variables required for the primary analyses.\n\nTreatment with the same index advanced therapy for more than 4 weeks before enrollment.\n\nParticipation in an interventional clinical trial that could interfere with the study assessments or outcomes.\n\nAny other condition that, in the investigator's judgment, would make participation inappropriate or prevent adequate follow-up.","ALL","60 Years",{"count":84,"type":85},300,"ESTIMATED","104 Weeks","OBSERVATIONAL","The goal of this observational study is to learn whether signs of immune aging and frailty can help predict the balance of benefits and risks of advanced therapies in adults aged 60 years or older with inflammatory bowel disease (IBD) who are starting a new advanced therapy. Treatment will be chosen by the participant's usual clinical team and will not be assigned by the study.\n\nThe main questions it aims to answer are:\n\nAre baseline immune-aging and frailty characteristics associated with net clinical benefit at 52 weeks, defined as steroid-free clinical remission without serious infection, treatment discontinuation because of adverse events, IBD-related hospitalization, or IBD-related surgery? Can a low-cost combination of clinical and laboratory markers help identify older adults with IBD who are more likely to have favorable or unfavorable outcomes after starting advanced therapy?\n\nParticipants will:\n\nContinue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors.\n\nHave routine and study-related blood tests, including measures related to immune aging such as CD4\u002FCD8 ratio and interleukin-6 (IL-6).\n\nBe followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible.\n\nHave information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.",[90,91,92],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Frailty","Immunosenescence",[94,91,95,96,97,98],"Geriatric IBD","Advanced Therapies","Treatment Outcomes","Net Clinical Benefit","Risk Stratification","NOT_YET_RECRUITING","2026-09-20",{"date":102,"type":103},"2026-09-22","ACTUAL",{"date":105,"type":85},"2026-09-01",{"date":107,"type":85},"2030-09-30",{"name":5,"class":6}]