Inflammatory Bowel Disease (IBD)
Conditions
Interventions
Conventional Therapy Group (primarily mild-moderate active IBD):Mesalazine or mesalazine combined with glucocorticoids, oral administration for 12 weeks +/- 7 days followed by reassessment.
Biologic Agent A1 Group (primarily moderate-severe active IBD):Infliximab: Reassessment at 14 weeks +/- 7 days before the fourth intravenous infusion.
Vedolizumab: Reassessment at 14 weeks +/- 7 days
Biologic Agent A2 Group (primarily moderate-severe active IBD):Ustekinumab: Reassessment at 24 weeks +/- 7 days before the fourth administration.
Sponsors
The Seventh Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 75 Years
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria are eligible: (1) Confirmed diagnosis of active Crohn's disease (CD) or ulcerative colitis (UC) per: Chinese Guidelines for Ulcerative Colitis Diagnosis and Treatment (2023, Xi'an); Chinese Guidelines for Crohn's Disease Diagnosis and Treatment (2023, Guangzhou). (2) Aged 0–75 years (any gender); (3) Complete clinical data including:Demographics, Clinical symptoms, Laboratory tests (blood/stool routine, fecal occult blood [OB], biochemistry, immunology, inflammatory/infection markers), Imaging studies (abdominal radiology, ultrasound, endoscopy); (4) Willingness to participate with signed informed consent from patients/families, including compliance with follow-up.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following are excluded: (1) Unwilling to undergo follow-up; (2) Inability of patients/families to comprehend study objectives and requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;AUC-ROC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predictive value;Negative predictive value;Positive likelihood ratio(LR+);Negative likelihood ratio(LR-);Diagnostic odds ratio;Accuracy;Spearman’s ?;Clinical decision curve analysis; | — |
Countries
China
Contacts
Public ContactYan Jia
The Seventh Medical Center of Chinese PLA General Hospital
Outcome results
None listed