Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Josip Juraj Strossmayer University of Osijek | OTHER |
Not provided
Not provided
Not provided
Not provided
Inflammatory bowel disease consists of ulcerative colitis (UC) or Crohn's disease (CD). The main aim of this study is to describe real-world data on vedolizumab serum concentration and treatment outcomes in cohort of patients treated at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. Study will be recruiting patients who switched from intravenous to subcutaneous vedolizumab according to routine clinical practice.
This is a non-interventional, prospective study of participants with IBD who switched from intravenous to subcutaneous vedolizumab in the real world setting.
The study will enroll approximately 30 participants. The data will be collected at the Department of Gastroenterology and Hepatology of University Hospital Center Osijek. All the participants will be assigned to a single observational cohort. All procedures (e.g., blood draw for serum trough concentration of vedolizumab, stool collection for fecal calprotectin or colonoscopy) will be done for routine clinical care. Data will be collected at baseline and at 6-12 months after switch from intravenous to subcutaneous vedolizumab. At baseline, data on age, gender, body mass, diagnosis, time from diagnosis, prior and concomitant therapy for IBD, comorbidities, time from switch from vedolizumab IV to vedolizumab SC, and vedolizumab serum trough concentration during vedolizumab IV therapy, will be collected. At control visit, data on concomitant therapy, adverse events, hospitalization, surgery and vedolizumab serum trough concentration during vedolizumab SC therapy, will be collected. For evaluation of disease remission at baseline and at control visit, Harvey-Bradshaw index (HBI) for Crohn's disease and Partial Mayo score (PMS) for ulcerative colitis (HBI <5 or PMS <2); or value of fecal calprotectin (<150 µ/g); or Simple Endoscopic Score for Crohn's disease (SES-CD) and Mayo endoscopic subscore (MES) for ulcerative colitis (SES-CD <3 or MES <2), will be used.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with IBD | Participants diagnosed with IBD (UC or CD) who switched from vedolizumab IV to vedolizumab SC treatment during routine clinical practice, will be observed prospectively for up to 12 months from switch. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Serum Vedolizumab Through Concentration After Switching from Vedolizumab IV to Vedolizumab SC | Up to 12 months from switch | |
| Percentage of Participants in Remission After Switching to Vedolizumab SC | Remission status will be defined by clinical scores (Harvey-Bradshaw index <5 or Partial Mayo score <2), by fecal calprotectin (< 150 mcg/g; if done) or by endoscopic score (SES-CD<3 or Mayo endoscopic subscore<2; if done). | Up to 12 months from switch |
| Rate of Hospitalizations After Switching to Vedolizumab SC | Hospitalizations due to inflammatory bowel disease activity or complications will be taken into account. | Up to 12 months from switch |
| Rate of Surgery After Switching to Vedolizumab SC | Surgery due to inflammatory bowel disease activity or complications will be taken into account. | Up to 12 months from switch |
| Rate of Treatment Change After Switching to Vedolizumab SC | Treatment change is defined as start of corticosteroid therapy, switch to vedolizumab IV again or switch to another biologic or small molecule. | Up to 12 months from switch |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
1. Corticosteroid therapy at time of switch from vedolizumab IV to vedolizumab SC
Not provided
Not provided
Not provided
Adult participants with UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vlasta Oršić Frič, MD | University Hospital Center Osijek | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinički bolnički centar Osijek (University Hospital Center Osijek) | Osijek | 31000 | Croatia |
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided