Trial document




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  DRKS00014249

Trial Description

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Title

Monitoring of Vedolizumab Infusion Therapy response with fecal calprotectin, ultrasound and trough serum level in Ulcerative colitis. A multicentric, prospective non-interventional Study

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Trial Acronym

MOVE-IT

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URL of the Trial

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Brief Summary in Lay Language

With this study, we aim to gain a deeper understanding of therapeutic development in patients with moderate to severe ulcerative colitis. Patients are regularly monitored for the medication vedolizumab. The aim is to obtain an optimized treatment protocol for the treatment of ulcerative colitis with the drug Vedolizumab. The study investigates whether clinical response to vedolizumab can be predicted at week 14 after initiation of therapy. These parameters are measured by measuring abdominal ultrasound, stool and blood markers and the drug level.

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Brief Summary in Scientific Language

With this study, we aim to gain a deeper understanding of therapeutic development in patients with moderate to severe ulcerative colitis who regularly receive vedolizumab. The aim is to develop an algorithm for optimizing vedolizumab administration in patients with ulcerative colitis by calculating the likelihood of clinical response at week 14 with early data (abdominal ultrasound, fecal calprotectin, and drug levels) from week 6.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00014249
  •   2018/07/18
  •   [---]*
  •   yes
  •   Approved
  •   D 428/18, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   Patients with diagnosis ulcerative colitis.
    For the examination weeks 0, 6, 14 and 22 abdominal ultrasound is measured as well as stool and blood markers and medicament levels.
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Characteristics

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

The goal is to predict the clinical response to vedolizumab therapy at week 14 by at least two improved markers (drug levels, abdominal ultrasound and / or calprotectin) at week 6.

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Secondary Outcome

Measuring of fecal calprotectin, abdominal ultrasound, and drug level at week 6 to predict the likelihood of clinical response to the integrin antibody vedolizumab therapie at week 22.
In addition, it is being investigated whether other stool markers (lactoferrin, S100A12 or PMN elastase) can be used as predictors of clinical response to vedolizumab therapy.

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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 
  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/31
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

1. Reliable diagnosis of ulcerative colitis> 3 months (endoscopically and clinically)

2. Secured disease due to increased fecal calprotectin ≥ 100 μg / g and / or endoscopic score UCEIS ≥ 3, within 3 weeks prior to baseline

3. Ultrasound detectable disease; Sonographic signs of active inflammation, determined by the thickness of the intestinal wall:> 3 mm (colon)

4. If treatment with vedolizumab independent of the present study has been performed in accordance with routine medical practice, there should be at least a 12 week break between end and beginning

5. Age between ≥ 18 and 80 years

6. Signed written consent is available

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Exclusion Criteria

1. Pregnancy and lactation

2. Indication for vedolizumab therapy outside the product information

3. Contraindications for treatment with vedolizumab (according to product information)

4. ileostomy or ileoanal pouch

5. Infectious colitis (e.g., Clostridium difficile colitis, cytomegalovirus colitis)

6. Obesity ≥ Grade I (BMI> 30): inadequate sonographic log wall imaging

7. Proctitis

8. Participation in an intervention study within the last 30 days prior to initiation of therapy.

9. Other medical reasons.

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Addresses

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    • Internistische Gemeinschaftspraxis
    • Mr.  Priv.-Doz. Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Str. 30
    • 26123  Oldenburg
    • Germany
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    • Universität zu Kiel und Internistische Gemeinschaftspraxis
    • Mr.  Priv.-Doz. Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Str. 30
    • 26123  Oldenburg
    • Germany
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    • Universität zu Kiel und Internistische Gemeinschaftspraxis
    • Mr.  Priv.-Doz. Dr. med.  Ulf  Helwig 
    • Neue Donnerschweer Str. 30
    • 26123  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • Takeda Pharma Vertrieb GmbH & Co. KG
    • Jägerstraße 27
    • 10117  Berlin
    • Germany
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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.