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

CED Service GmbH

Status: Unknown

Conditions: Treatment; Inflammatory Bowel Diseases

Treatments: Biological: vedolizumab

Study type: Observational

Funder types: Other

Identifiers

NCT03375424

Version 1.4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,500 participants in 3 patient groups

1st subpopulation

Description:

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.

Treatment:

Biological: vedolizumab

2nd subpopulation

Description:

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

Description:

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.