A Fecal marker of Intestinal inflammation for RElapse prediction in routine monitoring of Crohn's disease patients (FIRE)

• Conditions: K50.1; Crohn disease of large intestine

• Registration Number: DRKS00010937
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-05-20
• Study Start: 2016-08-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 525

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

active disease (HBI = 5); current treatment of CD with corticosteroids; disease patterns restricted to proximal (small bowel, gastroduodenal) GI areas; pregnancy.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).