Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

NCT03375424 | Unknown

• 1 other identifier: Version 1.4
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Treatment

Keywords

Vedolizumab, Crohns disease, Ulcerative colitis, safety

Outcome Measures

Primary Outcomes (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)

  Success - no; Failure - yes

  through study completion, an average of 1 year

Secondary Outcomes (9)

• Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease

  during the first 14 weeks after individual participation

• Development of a multifactorial model to predict a favorable course of disease

  through study completion, an average of 1 year

• Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects

  through study completion, an average of 1 year

• 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

  through study completion, an average of 1 year

Study Arms (3)

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

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.

Interventions

vedolizumab BIOLOGICAL

duration of disease and kind of therapy

1st subpopulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ced Service GmbH: lead

Study Sites (1)

Gastroenterologische Gemeinschaftspraxis Minden

Minden, Lower Saxony, 32423, Germany

RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Bernd Bokemeyer, PD Dr. med.

  Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Koch

CONTACT

+49 431/592 957 5600; a.koch@kompetenznetz-ced.de

Maria Stumpe

CONTACT

+49 151 291 106 89; mstumpe@intermedcon.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: December 18, 2017
• Study Start: October 2, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2024
• Last Updated: December 18, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)