Inflammatory bowel disease
Conditions
Interventions
Standard Corticosteroid Tapering Group:Standard Corticosteroid Tapering Regimen
Rapid Corticosteroid Tapering Group:Rapid Corticosteroid Tapering Regimen
Sponsors
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years (inclusive), both sexes eligible; 2. Established diagnosis of IBD (Crohn's disease or ulcerative colitis) prior to baseline (Week 0), confirmed by clinical manifestations, imaging evidence, and supportive histopathological reports; 3. Active disease at baseline: (1) For UC: Modified Mayo score >=3 (2) For CD: Crohn's Disease Activity Index (CDAI) >=150; 4. Receiving concomitant induction therapy with anti-tumor necrosis factor (anti-TNF-a) agents and systemic corticosteroids; 5. Voluntarily provide written informed consent, willing to comply with study protocol and accept all scheduled assessments (including endoscopic examinations and disease evaluations);
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of Inflammatory Bowel Disease Unclassified (IBD-U, formerly indeterminate colitis). Hereditary immunodeficiency syndromes or known monogenic IBD. Prior history of bowel resection or intra-abdominal surgery. Evidence of toxic megacolon, intra-abdominal abscess, or small intestinal/rectal strictures or obstruction; 2. Evidence of active tuberculosis (TB) or history of active TB regardless of prior treatment. Positive HIV antibody test or diagnosis of AIDS at screening. Acute or chronic hepatitis B virus infection; or positive HBsAg/HBV DNA at screening. Hepatitis C virus infection; or positive HCV antibody with detectable HCV RNA at screening. Clostridioides difficile or other enteric infections within 30 days prior to screening endoscopy, or positive pathogen testing at screening. Evidence of active or infectious herpes zoster within <=8 weeks prior to screening; 3. History of lymphoma, leukemia, or any malignancy within the most recent 10 years; 4. Extra-abdominal surgery prior to screening with incomplete postoperative recovery (including non-healed wounds); 5. Uncontrolled neuropsychiatric disorders or suicidal risk as judged by the investigator; 6. Unstable or uncontrolled systemic diseases including but not limited to cardiovascular, cerebrovascular, respiratory, hepatic, renal, endocrine, hematological, or neurological disorders (other than IBD); 7. Requirement of systemic corticosteroids for non-IBD conditions (except replacement therapy for adrenal insufficiency); 8. History of severe allergy or intolerance to anti-TNF agents or corticosteroids; 9. Prior solid organ transplantation or hematopoietic stem cell transplantation; 10. Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 20 weeks after the last dose of study medication; 11. Current alcohol dependence and/or drug abuse, or history of alcohol dependence/drug abuse within the past year;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week 14 Corticosteroid-Free Clinical Remission (CFCR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Infections;Week 14 Endoscopic Remission Rate;Inflammatory Biomarker Levels;Cumulative Corticosteroid Dose and Treatment Duration; | — |
Countries
China
Contacts
Public ContactLan Li
The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed