Trial document




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  DRKS00005940

Trial Description

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Title

Early MOnitoring of REsponse on the therapy of Golimumab (GLM) with fecal calprotectin and trough serum levels in patients with ulcerative colitis. A multicentric, prospective study

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Trial Acronym

MORE

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to expand knowledge of the course of golimumab therapy in patients with moderate to severe ulcerative colitis by means of standard care therapy and assessments. Study participants might contribute to a future early identification of patients which do respond or do not respond to golimumab therapy, respectively.

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Brief Summary in Scientific Language

The aim of the study is to expand knowledge of the course of golimumab therapy in patients with moderate to severe ulcerative colitis by means of standard care therapy and assessments. Based on this knowledge an algorithm for the optimized use of golimumab in patients with moderate to severe ulcerative colitis will be generated. The decision tool of the algorithm is based on the data from week 6, calculating the probability for clinical response on week 26.

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Organizational Data

  •   DRKS00005940
  •   2014/09/23
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  •   yes
  •   Approved
  •   D468/14, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

  •   U1111-1153-8330 
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Health Condition or Problem studied

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

  •   In patientes with ulcerative colitis fecal calprotectin and serum GLM and anti-GLM level are analyzed. Calprotectin will be monitored in week 0, 2, 6, 14, 22 and 26. GLM level will be monitored in week 2 and 6 and anti-GLM lewvel in week 0, 2 and 6.
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Characteristics

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

To evaluate a 50% reduction of fecal calprotectin and a positive GLM trough level at week 6 to predict clinical response at week 26.

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Secondary Outcome

1. At which point in time is a reduction of 50% of calprotectin a reliable predictor of response?
2. How strong is the correlation between Antibodies-Towards-GLM (ATG) and fecal calprotectin?
3. How strong is the correlation between ATG and Partial Mayo Score?
4. How strong is the correlation between GLM trough level and fecal calprotectin?
5. How strong is the correlation between GLM trough level and Partial Mayo Score.
6. Are serum CRP levels, leucocyte count, hemoglobin levels, thrombocyte count or ferritin levels constraining factors for the clinical response due to GLM treatment?

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
  • Doctor's Practice 
  • Doctor's Practice 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/10/24
  •   61
  •   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

1. Established diagnosis of ulcerative colitis by endoscopical and clinical determination
2. Trial-independend treatment with golimumab according to routine local prescribing practice at the discretion of the investigator
3. Minimum age of 18 years
4. The patient must be capable in communicating sufficiently in German
5. The patient must be able to recognize the nature, significance and scope of the study and must agree in a written informed consent.
6. Increased level of calprotectin (≥100 mg/l or ≥100 mg/kg) within 3 weeks prior to inclusion or existing endoscopic record of a distinct inflammatory response (UCEIS ≥ 3 points).

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Exclusion Criteria

1. Infectious colitis
2. Treatment with Golimumab outside the label
3. Treatment with Golimumab within the last 3 month

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Addresses

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    • GISG Organisationsbüro Kompetenznetz Darmerkrankungen
    • Mr.  Klaus  Fitzke 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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    • Internistische Praxisgemeinschaft Oldenburg
    • Mr.  PD Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Straße 30
    • 26123  Oldenburg
    • Germany
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    • Internistische Praxisgemeinschaft Oldenburg
    • Mr.  PD Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Straße 30
    • 26123  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • GISG Organisationsbüro, Kompetenznetz Darmerkrankungen
    • Mr.  Klaus  Fitzke 
    • Hopfenstraße 60
    • 24103  Kiel
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/06/21
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Trial Publications, Results and other Documents

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