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

NCT ID: NCT05504915

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 31 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-05-31

Brief 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.

Detailed 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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role: collaborator

Osijek University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Vlasta Orsic Fric

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vlasta Oršić Frič, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Center Osijek

Locations

Klinički bolnički centar Osijek (University Hospital Center Osijek)

Osijek, , Croatia

Countries

Croatia

Other Identifiers

DGH01

Identifier Type: -

Identifier Source: org_study_id