K50 K51
Conditions
Interventions
Group 1: Study participants:
Inclusion criteria for patients with active disease (study part 1)
1. Reliable diagnosis of Crohn's disease (active disease): a. HBI=7 and
b. Sonographic signs of active i
Sponsors
Takeda Pharma Vertrieb GmbH & Co KG
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients with active disease (study part 1): 1. Reliable diagnosis of Crohn's disease (active disease): a. HBI = 7 and b. Sonographic signs of active inflammation: intestinal wall thickness> 3.0 mm (colon) or> 2.0 mm (terminal ileum) OR Reliable diagnosis of ulcerative colitis (active disease): a. SCCAI = 5 and b. Sonographic signs of active inflammation: Intestinal wall thickness> 3.0 mm (Colon) 2. Study-independent therapy with vedolizumab according to medical practice 3. Age 18 to 70 years 4. Sufficient communication skills in the German language 5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly Inclusion criteria for patients in remission (study part 2): 1. Reliable diagnosis of Crohn's disease (remission): HBI = 4 OR Reliable diagnosis of ulcerative colitis (remission): SCCAI = 5 2. Study-independent therapy with vedolizumab according to medical practice 3. Age 18 to 70 years 4. Sufficient communication skills in the German language 5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding 2. Therapy with vedolizumab out of authorization 3. Contraindication to treatment with vedolizumab (sec.reg. FI) 4. Severe symptomatic strictures without signs of blood flow 5. Ileostoma or ileoanal pouch 6. Infectious colitis (e.g., Clostridium difficile colitis, Cytomegalovirus colitis) 7. Obesity = grade I (BMI> 30) (insufficient, sonographic bowel wall imaging) 8. Ulcerative colitis: proctitis Crohn's disease: infestation of the upper GI tract (esophagus, stomach) 9. Participation in an intervention study within the last 30 days prior to initiation of therapy 10. Other medical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Statistical evaluation a. the proportion of Crohn's disease patients with a reduction in bowel wall thickness of = 25% at week 14 compared to baseline at baseline of the induction phase (yes / no) with b. the proportion of Crohn's disease patients without a reduction in bowel wall thickness of = 25% at week 14 compared to the baseline baseline of the induction phase (yes / no), who responded to vedolizumab after 14 weeks (end of induction therapy) compared to those who did not respond. Statistical evaluation a. of the proportion of ulcerative colitis patients with a reduction in iliac wall thickness of = 25% at week 14 compared to baseline in induction baseline (yes / no) with b. the proportion of ulcerative colitis patients without a reduction in bowel wall thickness of = 25% at week 14 compared to the baseline baseline of the induction phase (yes / no), who have responded clinically to vedolizumab after 14 weeks (end of induction therapy) compared to those who did not respond. Statistical evaluation a. the proportion of Crohn's disease patients with an increase in bowel wall thickness of = 25% within any time point in the maintenance phase compared to baseline at baseline of remission (yes / no) with b. Crohn's disease Patients with no increase in bowel wall thickness of = 25% within any stage in the maintenance phase compared to baseline baseline (yes / no). who responded to vedolizumab after 14 weeks (end of induction therapy) and relapsed later in the remission compared to those who did not relapse. Statistical evaluation a. of the proportion of ulcerative colitis patients with an increase in bowel wall thickness of = 25% within any time point in the maintenance phase compared to baseline in the baseline of remission (yes / no) with b. the proportion of ulcerative colitis patients with no increase in bowel wall thickness of = 25% within any stage of maintenance compared to baseline baseline (yes / no). who responded to vedolizumab after 14 weeks (end of inducti | — |
Secondary
| Measure | Time frame |
|---|---|
| Analogous to the formulation of the primary target criterion, all parameters of the intestinal sonography should be investigated: 1. Separated for mucosa and submucosa 2. Separated for the individual intestinal sections Furthermore, it will be investigated: 1. Correlation between parameters of the intestinal sonography and the clinical parameters; 2. Correlation between parameters of colon ultrasonography and the endoscopic parameters; 3. Correlation between calprotectin and clinical relapse in the maintenance phase; 4. Correlation between CRP and clinical relapse in the maintenance phase; 5. Frequencies of adverse drug reactions (ADRs). | — |
Countries
Germany, Switzerland
Contacts
Public ContactSandra Plachta-Danielzik
CED Service GmbH
Outcome results
None listed