Trial document




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  DRKS00004240

Trial Description

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Title

Do cutaneous adverse events significantly affect monoclonal antibody based anti-TNF therapies in inflammatory bowel disease patients? A national experience throughout all care levels through the German Inflammatory Bowel Disease Study Group.

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Trial Acronym

GISG SKIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Main purpose: systematic investigation of the impact of anti-TNF skin reactions on the anti-TNF therapy
Background:patients frequently develope anti-TNBF related skin reactions
Potential Participants: Adult, consented patientwh Crohn's disease or ulcerative colitis who begin an anti-TNF therapy
Aim: Improvement of medication safety with anti-TNF biologics
Hypothesis: H0 The likelyhood of a medical regimen change is independent of the skin reaction in the preceeding month

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Brief Summary in Scientific Language

This study systematically investigates the impact of adverse events associated with monoclonal antibody based anti-TNF therapies in patients with Crohn's disease and ulcerative colitis.

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Organizational Data

  •   DRKS00004240
  •   2012/07/09
  •   [---]*
  •   yes
  •   Approved
  •   EA2/033/12, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   K50.9 -  Crohn's disease, unspecified
  •   K51.9 -  Ulcerative colitis, unspecified
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Interventions/Observational Groups

  •   All patients who begin a new anti-TNF therapy for Crohn's disease or ulcerative colitis.
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Characteristics

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

Primary Endpoint: Impact of a skin reaction during the preceeding month on the anti-TNF therapy in the ongoing month.

Primary statistical analysis: comparison of the likelyhood of a therapy modification in a particular month if during the preceeding month

(a) no skin reaction occured versus
(b) a skin reaction occured

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Secondary Outcome

• How common are skin reactions are anti-TNF related skin reactions in Crohn's disease and ulcerative colitis?
• which skin reactions do occur?
• When do they occur?
• Do skin reactions correlate with the disease phenotype?
• Does the inflammatory activity correlate with skin reactions?
• Do patient demographics correlate with skin reactions??
• Do skin reactions correlate with concomitant mdeications?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2012/12/01
  •   220
  •   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

Valid informed consent. Patients who receive a monoclonal anti-TNF agent for Crohn's disease or ulcerative colitis for the first time.

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Exclusion Criteria

Known skin disorder. Dermatological manifestation of the underlying disease.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité Campus Virchow-Klinikum
    • Mr.  Prof. Dr. med.  Daniel C.   Baumgart 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Mr.  Prof. Dr. med.  Daniel C.  Baumgart 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Ms.  Andrea  Steingräber 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Morbus Crohn/Colitis ulcerosa Vereinigung - DCCV -
    • Ms.  Christine  Witte 
    • Reinhardtstraße 18
    • 10117  Berlin
    • Germany
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    • Kompetenznetz chronisch entzündliche Darmerkrankungen
    • Mr.  Dipl.-Betr.  Klaus  Fitzke 
    • Haus 27, Arnold-Heller-Str. 3
    • 24105  Kiel
    • Germany
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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting planned
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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.