Trial document





This trial has been registered retrospectively.
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  DRKS00010937

Trial Description

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Title

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

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Trial Acronym

FIRE

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URL of the Trial

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Brief Summary in Lay Language

The aim of this study is to investigate if the fecal inflammatory markers calprotectin is a suitable instrument for the routine monitoring of disease activity in patients with Crohn's disease. Therefore, the time period between a detected relevant increased level of fecal calprotectin and the occurrence of a clinical relapse of at least moderate disease activity (Harvey Bradshaw Index (HBI) ≥ 7) will be evaluated. The hypothesis for the primary outcome is that increased calprotectin levels at least 3 months before the occurrence of clinical relapse (HBI ≥ 7) are measurable.

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Brief Summary in Scientific Language

The purpose of this study is to investigate if the fecal inflammatory marker calprotectin is a suitable instrument for the routine monitoring of disease activity in patients with Crohn's disease. The primary outcome is to measure the time lag between an increase of calprotectin levels and the occurrence of a clinical relapse (defined as HBI ≥ 7).
Further purposes are to define calprotectin basal values in clinical remission and threshold values for describing the risk of recurrence, and the predictive value of calprotectin in certain subpopulations of patients. The hypothesis for the primary outcome is that increased calprotectin levels at least 3 months before the occurrence of clinical relapse (HBI ≥ 7) are measurable.

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Forwarding of patient-related data:

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010937
  •   2016/08/09
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  •   no
  •   Approved
  •   A 108/11, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50.1 -  Crohn disease of large intestine
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Interventions/Observational Groups

  •   participating patients will be exmined in routine visits every 3 month. Calprotectin and HBI levels will be examined.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

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.

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Secondary Outcome

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).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2011/10/27
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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.

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Exclusion Criteria

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

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Addresses

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    • AbbVie Deutschland GmbH & Co. KG
    • Mainzer Str. 81
    • 65189  Wiesbaden
    • Germany
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    •   +49 611 17200
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    • Universitätsklinikum Schleswig-HolsteinCampus KielKlinik für Innere Medizin 1
    • Ms.  Prof. Dr. med.  Susanna  Nikolaus 
    • Arnold-Heller Straße 3, Haus C und Haus K3
    • 24105  Kiel
    • Germany
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    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Dr.  Lars  Volkmann 
    • Mainzer Str. 81
    • 65189   Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • AbbVie Deutschland GmbH & Co. KG
    • Mainzer Str. 81
    • 65189  Wiesbaden
    • Germany
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    •   +49 611 17200
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2016/05/20
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Trial Publications, Results and other Documents

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