NCT05645055RecruitingNot Applicable
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Jinling Hospital, China1 site in 1 country200 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- clinical remission rate at 1 year
Study Overview
Brief Summary
Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with stricturing Crohn's diseases
- •no surgical indication
- •patients with asymptomatic penetrating diseases
- •written consent acquired
Exclusion Criteria
- •patients with surgical indication
- •patients with symptomatic penetrating diseases
- •contraindication of biologics
- •anticipating other trial
Outcomes
Primary Outcomes
clinical remission rate at 1 year
Time Frame: clinical remission rate at 1 year
clinical remission rate at 1 year (CDAI less than 150)
Secondary Outcomes
- quality of life of patients assessed by Short form 12(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- surgical recurrence rate at 1 and 5 year(at 1 and 5 year)
- quality of life of patients assessed by IBDQ(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- score of obstructive(at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year)
- endoscopic recurrence rate at 1 and 5 year(at 1 and 5 year)
- clinical remission rate at 5 year(clinical remission rate at 5 year)
Investigators
Zhu Weiming
Senior Doctor, Principal Investigator, Clinical Professor
Jinling Hospital, China
Study Sites (1)
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