Trial document




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  DRKS00010596

Trial Description

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Title

Initiative for Development of Novel Biomarkers in Immune Neuropathies

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Trial Acronym

IDOBIN

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The most common chronic immune-mediated neuropathy is chronic inflammatory demyelinating polyneuropathy (CIDP). The course of the disease affects peripheral nerves, which is largely manifested by a gradually increasing weakness in the legs and arms. The increasing weakness proceeds over a longer period (two months or longer) and thus becomes chronically. The aim of the study is to identify clinical and biological parameters, in order to predict the disease course and outcome of CIDP in a fast and secure manner.

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Brief Summary in Scientific Language

During the investigation of CIDP, serum samples will be collected, which will be used for the determination of autoantibodies and biomarkers. Specific aspects will be evaluated: immunomodulatory and supportive treatments in clinical practice, pharmacokinetics of immunoglobulins (IVIg), prognostic relevance electrophysiological parameters, frequency of previous infections and the frequency of antineuronal antibodies.

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Organizational Data

  •   DRKS00010596
  •   2016/06/07
  •   [---]*
  •   yes
  •   Pending/not yet approved
  •   16-142, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1183-7798 
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Health Condition or Problem studied

  •   Chronic Inflammatory Demyelinating Polyneuropathy
  •   G61.8 -  Other inflammatory polyneuropathies
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Interventions/Observational Groups

  •   Obtaining serum and PBMC samples during the study for the determination of autoantibodies and biomarkers. The blood collection will be performed in total for six times (at 0, 3, 6, 9, 12, 24 months).
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Characteristics

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

Identification of clinical parameters, autoantibodies and biomarkers to predict the disease course and outcome of chronic inflammatory demyelinating polyneuropathy in (CIDP) as quick as possible and with maximum safety.

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
  •   India
  •   Norway
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2016/07/01
  •   100
  •   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

1. Fulfil the diagnostic criteria for CIDP of the Joint Task force of the European Federation of Neurological Societies and the Peripheral Nerve Society. 2. IVIG therapy.

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Exclusion Criteria

1. Below the age of 18. 2. Pregnancy.

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Addresses

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    • Universitätsklinkium Köln
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    •   [---]*
    •   [---]*
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    • Klinikum der Universität zu Köln (AöR) • AG Erkrankungen des peripheren Nervensystems LFI – Neurologisches Labor, Eb.5 R.406/407
    • Mr.  Dipl.-Biol.  Ilja  Bobylev 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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    • Neurologie, Universitätsklinik Kön
    • Mr.  Dr.  Helmar  Lehmann 
    • Kerpener Str. 62
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  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.