Observational Study for the Outcome After Discontinuing TNF Blockers in Crohn’s Disease
- Conditions
- K50Crohn disease [regional enteritis]
- Registration Number
- DRKS00005154
- Lead Sponsor
- German Inflammatory Bowel Diseases Study Group, c/o Kompentenznetz chronisch entzündliche Darmerkrankungen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
diagnosis: Crohn's disease
- uninterrupted treatment with adalimumab or infliximab for at least 6 months
- HBI <= 3
- planned ending of treatment with TNF blocker
- last dose of TNF blocker
* within three weeks with adalimumb
* within nine weeks with infliximab
Exclusion Criteria
- stopping of treatment because of lack of response of fistulizing disease
- existence of ileostomy or colostomy
- glucocorticoids within the last three months
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method After 3, 6, 9, and 12 months patients will be clinically assessed whether they had a relapse since the last visit. The primary endpoint ist the cumulative rate of patients with a relaps within 12 months.
- Secondary Outcome Measures
Name Time Method 1a) association of relapse rate during one year with histological markers<br>1b) association of relapse rate during one year with endoscopic, clinical or laboratoy markers<br>2) Cumulative relapse rte in predefined subgroups<br>3) endoscopic activity after one year as a surrogate for the long term natural course