Trial document





This trial has been registered retrospectively.
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  DRKS00009858

Trial Description

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Title

Understanding the impact of Ulcerative Colitis and its associated disease burden on
patients

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Trial Acronym

ICONIC

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URL of the Trial

http:// -

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Brief Summary in Lay Language

The overall aim of this study is to increase awareness and understanding of the multi-faceted disease burden associated with Ulcerative Colitis, to enable improved UC management and understanding.

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Brief Summary in Scientific Language

The key objectives are
to describe the multi-faceted burden of disease in recently diagnosed patients with Ulcerative Colitis, to investigate the correlation between patient and physician perception of Ulcerative Colitis disease and to estimate resource utilisation associated with Ulcerative Colitis and investigate the correlation between this and evaluated burden of disease.

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Organizational Data

  •   DRKS00009858
  •   2016/01/19
  •   [---]*
  •   no
  •   Approved
  •   41/15, Ethik-Kommission der Ärztekammer Berlin
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Secondary IDs

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

  •   K51.9 -  Ulcerative colitis, unspecified
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Interventions/Observational Groups

  •   This observational study will be performed in a prospective, 24-month follow-up, noninterventional format in Ulcerative Colitis patients. Patients will be asked to complete five short questionnaires or visual representations to provide an evalution of their perceived illness associated with disease, clinical symptom perception, levels of worry, anxiety and depression and quality of life.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

To evaluate PRISM (Pictorial Representation of Illness and Self Measure) as an assessment tool for perceived disease-associated suffering in Ulcerative Colitis patients, by assessing correlation with SIBDQ and PHQ-9 (quality of life), according to geographical location and disease severity.

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Secondary Outcome

To describe the multi-faceted burden of disease in recently diagnosed Ulcerative Colitis patients.

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Countries of Recruitment

  •   Germany
  •   Argentina
  •   Austria
  •   Bosnia and Herzegovina
  •   Bulgaria
  •   Canada
  •   Chile
  •   Colombia
  •   Croatia
  •   Czech Republic
  •   Egypt
  •   Estonia
  •   France
  •   Greece
  •   Ireland
  •   Israel
  •   Italy
  •   Japan
  •   Kuwait
  •   Mexico
  •   Portugal
  •   Romania
  •   Russian Federation
  •   Saudi Arabia
  •   Serbia
  •   Slovakia
  •   South Africa
  •   Spain
  •   Sweden
  •   Turkey
  •   Ukraine
  •   United Kingdom
  •   Venezuela, Bolivarian Republic of
  •   Slovenia
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/06/19
  •   1800
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Patients aged ≥ 18 years who have been diagnosed with Ulcerative Colitis ≤ 12 months prior to study
inclusion, signed a patient authorization form to use and disclose personal health information

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Exclusion Criteria

[---]*

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Addresses

  • start of 1:1-Block address primary-sponsor
    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Stefan  Rath 
    • Mainzer Str. 81
    • 65189  Wiesbaden
    • Germany
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    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Stefan  Rath 
    • Mainzer Str. 81
    • 65189  Wiesbaden
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Stefan  Rath 
    • 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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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.