Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
Location status: Recruiting
Recruiting
NCT Number: NCT05645055
Biologics for Stricturing Crohn's Diseases
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
16 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
treat these patients with biologics
Othertreat these patients with biologics
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
-
clinical remission rate at 5 year
Time frame: clinical remission rate at 5 year
clinical remission rate at 5 year (CDAI less than 150)
-
surgical recurrence rate at 1 and 5 year
Time frame: at 1 and 5 year
surgical recurrence : needing surgery for CD recurrence
-
endoscopic recurrence rate at 1 and 5 year
Time frame: at 1 and 5 year
endoscopic recurrence: rutgeerts over i2b
-
quality of life of patients assessed by IBDQ
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
IBDQ
-
quality of life of patients assessed by Short form 12
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
Short form 12
-
score of obstructive
Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year
range 0-6, higher means severe
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Jinling Hospital, China
Other
Registry information
Official study title
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Important dates
- Study start
- 2021
- Primary completion
- 2024
- Study completion
- 2029
- First posted
- Dec 9, 2022
- Registry last updated
- May 11, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.