Recruiting NCT05645055
Biologics for Stricturing Crohn's Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: treat these patients with biologics.
- Who it may be relevant to
- Registry conditions: The Efficacy of Biologics for Stricturing Crohn's Diseases. Basic parameters: 16 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Overview
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.
Interventions
- Other treat these patients with biologics
treat these patients with biologics
Primary outcome measures
- clinical remission rate at 1 year [Time frame: clinical remission rate at 1 year]
Secondary outcome measures (6)
- clinical remission rate at 5 year [Time frame: clinical remission rate at 5 year]
- surgical recurrence rate at 1 and 5 year [Time frame: at 1 and 5 year]
- endoscopic recurrence rate at 1 and 5 year [Time frame: at 1 and 5 year]
- 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]
- 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]
- score of obstructive [Time frame: at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Department of General Surgery, Jinling hosptal,Medical School of Nanjing University — Nanjing
Identifiers
NCT: NCT05645055 · JinlingH20221203