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Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

NCT03375424 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2017-12-18

No results posted yet for this study

Summary

This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the efficacy and safety of biologics in Germany in a real world situation. While the increasing use of anti-TNF-alpha antibodies in IBD-patients the new therapy with Vedolizumab opens up new opportunities in IBD-therapy, it may also pose new options and problems in terms of efficacy and predictors of response and potential side effects.

Conditions

  • Inflammatory Bowel Diseases
  • Treatment

Interventions

BIOLOGICAL

vedolizumab

duration of disease and kind of therapy

Sponsors & Collaborators

  • Ced Service GmbH

    lead OTHER

Principal Investigators

  • Bernd Bokemeyer, PD Dr. med. · Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-04-30
Completion
2024-04-30

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375424 on ClinicalTrials.gov