Real World Data on Vedolizumab Concentration and Outcomes in Inflammatory Bowel Disease (IBD) Patients Switching From Intravenous (IV) to Subcutaneous (SC) Vedolizumab in University Hospital Center Osijek

Crohn Disease Clinical Trial

Official title:

Prospective, Non-interventional, Observational Study in Cohort of Patients With IBD at University Hospital Center Osijek Switching From IV to SC Vedolizumab to Observe Vedolizumab Serum Concentration and Treatment Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504915
• Other study ID #: DGH01
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years and older

2. Diagnosis of IBD (UC or CD)

3. Signed informed consent

4. Switched to or planning to switch from vedolizumab IV to vedolizumab SC

5. Disease remission at the time of switch (according to clinical, laboratory or endoscopic parameters)

Exclusion Criteria:

1. Corticosteroid therapy at time of switch from vedolizumab IV to vedolizumab SC

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
Croatia	Klinicki bolnicki centar Osijek (University Hospital Center Osijek)	Osijek

Sponsors (2)

Lead Sponsor	Collaborator
Osijek University Hospital	Josip Juraj Strossmayer University of Osijek

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Serum Vedolizumab Through Concentration After Switching from Vedolizumab IV to Vedolizumab SC		Up to 12 months from switch
Primary	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
Primary	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
Primary	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
Primary	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