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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Treatment
• Intervention / 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
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Andrea Koch; Phone Number: +49 431/592 957 5600; Email: a.koch@kompetenznetz-ced.de
• Study Contact Backup: Name: Maria Stumpe; Phone Number: +49 151 291 106 89; Email: mstumpe@intermedcon.com

Study Locations

• Germany
  • Niedersachsen
    • Minden, Niedersachsen, Germany, 32423
      • Recruiting
      • Gastroenterologische Gemeinschaftspraxis Minden
      • Contact: Bernd Bokemeyer, PD Dr. med.; Phone Number: +49 571/22567; Email: mailto:bernd.bokemeyer@t-online.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Success - no; Failure - yes	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease	percent responders/remitters at week 2, 6 and 14, time to response, time to remission etc.	during the first 14 weeks after individual participation
Development of a multifactorial model to predict a favorable course of disease	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).	through study completion, an average of 1 year
Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects	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.	through study completion, an average of 1 year
Efficacy (remission and response) of induction therapy (week 14)	Efficacy (remission and response) of induction therapy (week 14)	through study completion, an average of 1 year
Generation of health economic data in IBD-patients on biologicals	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.	through study completion, an average of 1 year
Generation of follow-up data on IBD-patients with early disease	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.	through study completion, an average of 1 year
Formation of a large-scaled patient-collective of IBD-patients with an early course of disease	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.	through study completion, an average of 1 year
Efficacy (remission and response) of maintenance therapy (month 6 and 12)	maintenance therapy (month 6 and 12)	through study completion, an average of 1 year
Efficacy (remission and response) of effectiveness in different subpopulations	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)	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Ced Service GmbH
• Investigators: Principal Investigator: Bernd Bokemeyer, PD Dr. med., Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 18, 2017
• Last Update Submitted That Met QC Criteria: December 12, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Vedolizumab, Crohns disease, Ulcerative colitis, safety
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: Version 1.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No