Crohn Disease, Ulcerative Colitis
Conditions
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.
Interventions
DRUGBiologics
Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response | At week 14-26 | 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 |
| Mucosal healing | At week 42-64 | Mucosal healing is defined as absence of mucosal ulceration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | At week 14-26 and week 42-64 | Objective response was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 |
| Objective remission rate | At week 14-26 and week 42-64 | Objective remission was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64 |
| Inflammatory Bowel Disease Questionnaire (IBDQ) score | At baseline, week 14-26 and week 42-64 | IBDQ score at baseline, week 14-26 and week 42-64 |
| Clinical response rate with steroids or without steroids | At week 14-26 and week 42-64 | Clinical response rate with steroids or without steroids at week 14-26 and week 42-64 |
| EQ-5D score | At baseline, week 14-26 and week 42-64 | EQ-5D score at baseline, week 14-26 and week 42-64 |
| Incidence of adverse events | Through study completion | Incidence of adverse events through study completion |
| 36-Item Short Form Health Survey (SF-36) score | At baseline, week 14-26 and week 42-64 | SF-36 score at baseline, week 14-26 and week 42-64 |
| Clinical remission 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 |
Countries
China
Contacts
Primary ContactHongsheng Yang, MD
Outcome results
None listed