K50
Conditions
Interventions
Group 1: Patients with Crohn's disease who had been treated with a TNF blocker up until inclusion and where the TNF blocker ist stopped will be followed for a year clinically and endoscopically
Sponsors
German Inflammatory Bowel Diseases Study Group, c/o Kompentenznetz chronisch entzündliche Darmerkrankungen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
Exclusion criteria: - stopping of treatment because of lack of response of fistulizing disease - existence of ileostomy or colostomy - glucocorticoids within the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1a) association of relapse rate during one year with histological markers 1b) association of relapse rate during one year with endoscopic, clinical or laboratoy markers 2) Cumulative relapse rte in predefined subgroups 3) endoscopic activity after one year as a surrogate for the long term natural course | — |
Countries
Germany
Contacts
Public ContactKlaus Fitzke
German Inflammatory Bowel Diseases Study Group, c/o Kompentenznetz chronisch entzündliche Darmerkrankungen
Outcome results
None listed