Multi-omics to Predict Responses to Biologics in IBD

NCT05542459 | Unknown

• 1 other identifier: 2022ZSLYEC-136
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Clinical response

  The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI \<150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis

  At week 14-26

• Mucosal healing

  Mucosal healing is defined as absence of mucosal ulceration

  At week 42-64

Secondary Outcomes (8)

• Clinical response rate with steroids or without steroids

  At week 14-26 and week 42-64

• Clinical remission rate with steroids or without steroids

  At week 14-26 and week 42-64

• Objective response rate

  At week 14-26 and week 42-64

• Objective remission rate

  At week 14-26 and week 42-64

• Inflammatory Bowel Disease Questionnaire (IBDQ) score

  At baseline, week 14-26 and week 42-64

Study Arms (3)

Non-IBD control group

A control group in which patients are not diagnosed as inflammatory bowel disease.

CD group

A group in which patients are diagnosed as crohn's disease

Drug: Biologics

UC group

A group in which patients are diagnosed as ulcerative colitis

Drug: Biologics

Interventions

Biologics DRUG

Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD

CD group; UC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease treated with approved biologics

You may qualify if:

• For patients with IBD:
• Patients with IBD treated with approved biologics
• Age 18 or over
• Written informed consent obtained from patient for participation
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (1)

• Li Q, Huang Z, Yang H, Tang J, Zuo T, Yang Q, Huang Z, Guo Q, Li M, Gao X, Chao K. Intestinal mRNA expression profiles associated with mucosal healing in ustekinumab-treated Crohn's disease patients: bioinformatics analysis and prospective cohort validation. J Transl Med. 2024 Jun 26;22(1):595. doi: 10.1186/s12967-024-05427-w.

  PMID: 38926732 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, white cells, urine, feces, tissue

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Interventions

Biological Products

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Complex Mixtures

Central Study Contacts

Hongsheng Yang, MD

CONTACT

+86-20-38663423; hensonyang@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 15, 2022
• Study Start: January 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

CN (1)