The Efficacy of Biologics for Stricturing Crohn's Diseases
Conditions
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.
Interventions
OTHERtreat these patients with biologics
treat these patients with biologics
Sponsors
Jinling Hospital, China
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical remission rate at 1 year | clinical remission rate at 1 year | clinical remission rate at 1 year (CDAI less than 150) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgical recurrence rate at 1 and 5 year | at 1 and 5 year | surgical recurrence : needing surgery for CD recurrence |
| endoscopic recurrence rate at 1 and 5 year | at 1 and 5 year | endoscopic recurrence: rutgeerts over i2b |
| clinical remission rate at 5 year | clinical remission rate at 5 year | clinical remission rate at 5 year (CDAI less than 150) |
| 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 | Short form 12 |
| score of obstructive | at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year | range 0-6, higher means severe |
| quality of life of patients assessed by IBDQ | at 2, 4, 6 , 8 months and at 1, 2, 3, 4 and 5 year | IBDQ |
Countries
China
Contacts
Primary ContactWeiming wm Zhu, Ph.D.
Outcome results
None listed