K50.1
Conditions
Interventions
Group 1: participating patients will be exmined in routine visits every 3 month. Calprotectin and HBI levels will be examined.
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participating Crohn's disease patients are required to meet all of the following criteria: with status post moderate / severe disease flare which required treatment with steroids, immunosuppressives (Thiopurine,Methotrexat), and / or anti-TNF; currently in clinical remission (HBI < 5) for at least 1 month under therapy with immunosuppressives and / or TNF antibodies; ileocecal and / or colonic disease, with or without involvement of proximal (small bowel, gastroduodenal) GI areas.
Exclusion criteria
Exclusion criteria: active disease (HBI = 5); current treatment of CD with corticosteroids; disease patterns restricted to proximal (small bowel, gastroduodenal) GI areas; pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time period between measured relevant increased levels of fecal calprotectin and the occurrence of a clinical relapse of at least moderate disease activity (HBI = 7) within the 24 month study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline Calprotectin levels in clincial remission (HBI<5); Thresholds to describe the risk of recurrence; the predictive value of calprotectin in different patient subgroups (eg with respect to disease duration, disease localization, disease phenotype). | — |
Countries
Germany
Contacts
Public ContactLars Volkmann
AbbVie Deutschland GmbH & Co. KG
Outcome results
None listed