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Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany (VEDOibdI)

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ClinicalTrials.gov Identifier: NCT03375424
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Ced Service GmbH

Brief 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.

Condition or disease Intervention/treatment
Inflammatory Bowel Diseases Treatment Biological: vedolizumab

Detailed Description:

The IBD-patients will be prospectively documented in the BIOibd-Registry. The diagnosis is made in accordance with current DGVS/ECCO UC/CD guidelines. There are the following inclusion and exclusion criteria:

Inclusion Criteria:

  • IBD-patients (UC/CD) aged 18-80 years at enrollment
  • Written informed consent is given Exclusion Criteria:Lack of adequate documentation possibilities
  • Malignant disease in history
  • Planned surgical intervention

There are three subpopulations:

  1. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
  2. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
  3. IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed < 2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.

Patients with IBD on Vedolizumab/anti-TNF will be documented in a prospective online documentation form at the participating study sites. In parallel, these sites will also document consecutively early disease IBD patients who were diagnosed less than 2 years previously. These patients will be used as a control group.The data will be documented in an online documentation form. After initial documentation at enrollment and during induction (0, 2, 6 and 14 weeks), follow-up documentation using an abbreviated online follow-up form will be requested every 6 months during the longitudinal investigation. Any drug side effects are also captured online on a side effects form.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 60 Months
Official Title: Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany Documentation of Vedolizumab Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab
U.S. FDA Resources

Group/Cohort Intervention/treatment
1st subpopulation
IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
Biological: vedolizumab
duration of disease and kind of therapy
2nd subpopulation
IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
3rd subpopulation
IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.



Primary Outcome Measures :
  1. safety index (Chronic steroid-use ≥ 20 mg for ≥ 6 months, New secreting fistula, Op caused by stenosis, Mortality (all), Hospitalization > 14 days, Long-term-illness (with > 30 days off work), Early retirement) [ Time Frame: through study completion, an average of 1 year ]
    Success - no; Failure - yes


Secondary Outcome Measures :
  1. Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease [ Time Frame: during the first 14 weeks after individual participation ]
    percent responders/remitters at week 2, 6 and 14, time to response, time to remission etc.

  2. Development of a multifactorial model to predict a favorable course of disease [ Time Frame: through study completion, an average of 1 year ]
    Controlling the systematic analysis (e.g. Chronic steroid-use ≥ 20 mg for ≥ 6 months, new secreting fistula etc.) to forecast the good treatment of the participants (to avoid the primary outcome and to reach the secondary outcome/remission).

  3. Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects [ Time Frame: through study completion, an average of 1 year ]
    Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects (e.g. death, tumor, tuberculosis, serious infection or other side effects requiring hospitalization.

  4. Efficacy (remission and response) of induction therapy (week 14) [ Time Frame: through study completion, an average of 1 year ]
    Efficacy (remission and response) of induction therapy (week 14)

  5. Generation of health economic data in IBD-patients on biologicals [ Time Frame: through study completion, an average of 1 year ]
    Generation of health economic data in IBD-patients on biologicals (number of hospitalizations, kind of disabilties, cost of treatment, quality of life e.g. WPAI-CD or EQ-5D) through CRF.

  6. Generation of follow-up data on IBD-patients with early disease [ Time Frame: through study completion, an average of 1 year ]
    Generation of follow-up data on IBD-patients with early disease (initiation of documentation < 2 years after first diagnosis) through CRF (e.g. actual diagnostic findings or laboratory reports) and IBD-patients on biologics e.g. actual diagnostic findings or laboratory reports) with reference to treatment modalities and psychosocial impairment among patients.

  7. Formation of a large-scaled patient-collective of IBD-patients with an early course of disease [ Time Frame: through study completion, an average of 1 year ]
    Formation of a large-scaled patient-collective of IBD-patients (350 patients) with an early course of disease (disease course < 2 years) by combining different registries running on the BIOibd platform (6000 patients) of the IBD Competence Net in Germany for the comparison of special subgroups, e.g. IBD-patients on biologics.

  8. Efficacy (remission and response) of maintenance therapy (month 6 and 12) [ Time Frame: through study completion, an average of 1 year ]
    maintenance therapy (month 6 and 12)

  9. Efficacy (remission and response) of effectiveness in different subpopulations [ Time Frame: through study completion, an average of 1 year ]
    effectiveness in different subpopulations, e.g. based on prior biological therapy (remission: HBI ≤ 4 in CD and partial Mayo Score ≤ 1 plus a bleeding subscore of 0 in UC)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

There are three subpopulations:

  1. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced Vedolizumab (VDZ) therapy (n=1.800). A former therapy with other biologics is allowed. More than 30% of these Vedolizumab patients will be biologics-naiv.
  2. IBD-patients (age at enrollment: 18-80 years) receiving a newly introduced anti-TNF-alpha therapy other than VDZ (n=350) in biologics-naiv patients.
  3. IBD patients (age at enrollment: 18-80 years) with an early disease (n=350), who were first diagnosed <2 years before the start of documentation in the Investigator initiated non-interventional study (NIS) but have not yet received and are not planned to receive biologics in the near future.
Criteria

Inclusion Criteria:

  • IBD-patients (UC/CD) aged 18-80 years at enrollment
  • Written informed consent is given

Exclusion Criteria:

  • Lack of adequate documentation possibilities
  • Malignant disease in history
  • Planned surgical intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375424


Contacts
Contact: Andrea Koch +49 431/592 957 5600 a.koch@kompetenznetz-ced.de
Contact: Maria Stumpe +49 151 291 106 89 mstumpe@intermedcon.com

Locations
Germany
Gastroenterologische Gemeinschaftspraxis Minden Recruiting
Minden, Niedersachsen, Germany, 32423
Contact: Bernd Bokemeyer, PD Dr. med.    +49 571/22567    mailto:bernd.bokemeyer@t-online.de   
Sponsors and Collaborators
Ced Service GmbH
Investigators
Principal Investigator: Bernd Bokemeyer, PD Dr. med. Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden

Responsible Party: Ced Service GmbH
ClinicalTrials.gov Identifier: NCT03375424     History of Changes
Other Study ID Numbers: Version 1.4
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ced Service GmbH:
Vedolizumab, Crohns disease, Ulcerative colitis, safety

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Vedolizumab
Gastrointestinal Agents