Clinical trial NCT05542459: Multi-omics to Predict Responses to Biologics in IBD
Official title: Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Ulcerative Colitis
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease treated with approved biologics

Brief summary: Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).

Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.

In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.


Eligibility criteria: Inclusion Criteria:

1. For patients with IBD:

   * Patients with IBD treated with approved biologics
   * Age 18 or over
   * Written informed consent obtained from patient for participation
2. For non-IBD healthy volunteers:

   * Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study
   * Age 18 or over
   * Written informed consent obtained from patient for participation

Exclusion Criteria:

* Unable to obtain written informed consent
* Patient is, in the opinion of the investigator, not suitable to participate in the study

Primary outcomes:
measure: Clinical response
timeFrame: At week 14-26
measure: Mucosal healing
timeFrame: At week 42-64
Secondary outcomes:
measure: Clinical response rate with steroids or without steroids
timeFrame: At week 14-26 and week 42-64
measure: Clinical remission rate with steroids or without steroids
timeFrame: At week 14-26 and week 42-64
measure: Objective response rate
timeFrame: At week 14-26 and week 42-64
measure: Objective remission rate
timeFrame: At week 14-26 and week 42-64
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) score
timeFrame: At baseline, week 14-26 and week 42-64
measure: 36-Item Short Form Health Survey (SF-36) score
timeFrame: At baseline, week 14-26 and week 42-64
measure: EQ-5D score
timeFrame: At baseline, week 14-26 and week 42-64
measure: Incidence of adverse events
timeFrame: Through study completion
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References: