Clinical trial NCT03375424: Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Treatment
Keywords: Vedolizumab, Crohns disease, Ulcerative colitis, safety
Lead sponsor: Ced Service GmbH
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Comparison of the disease course in IBD-patients on Vedolizumab/anti-TNF therapy with IBD-patients with an early-stage disease
timeFrame: during the first 14 weeks after individual participation
measure: Development of a multifactorial model to predict a favorable course of disease
timeFrame: through study completion, an average of 1 year
measure: Online documentation of effectiveness in induction and maintenance therapy including the occurrence of serious side effects
timeFrame: through study completion, an average of 1 year
measure: Efficacy (remission and response) of induction therapy (week 14)
timeFrame: through study completion, an average of 1 year
measure: Generation of health economic data in IBD-patients on biologicals
timeFrame: through study completion, an average of 1 year
measure: Generation of follow-up data on IBD-patients with early disease
timeFrame: through study completion, an average of 1 year
measure: Formation of a large-scaled patient-collective of IBD-patients with an early course of disease
timeFrame: through study completion, an average of 1 year
measure: Efficacy (remission and response) of maintenance therapy (month 6 and 12)
timeFrame: through study completion, an average of 1 year
measure: Efficacy (remission and response) of effectiveness in different subpopulations
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
state: Niedersachsen
Study officials:
affiliation: Gastroenterologische Gemeinschaftspraxis Minden, Uferstr. 3, 32423 Minden
name: Bernd Bokemeyer, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: