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.
The main questions it aims to answer are:
Are 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?
Participants will:
Continue the advanced therapy selected as part of their usual clinical care. Complete study assessments of frailty, nutritional status, disease activity, and other health factors.
Have routine and study-related blood tests, including measures related to immune aging such as CD4/CD8 ratio and interleukin-6 (IL-6).
Be followed at approximately baseline, weeks 6, 14, 26, and 52, with longer-term safety follow-up planned to week 104 when feasible.
Have information collected on remission, infections, hospitalizations, surgery, treatment continuation or change, and other health outcomes.
None
None
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital, Sun Yat-Sen University
Lead sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
