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

NCT05504915 | Completed

• 1 other identifier: DGH01
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.

You may qualify if:

• years and older
• Diagnosis of IBD (UC or CD)
• Signed informed consent
• Switched to or planning to switch from vedolizumab IV to vedolizumab SC
• Disease remission at the time of switch (according to clinical, laboratory or endoscopic parameters)

You may not qualify if:

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

Sponsors & Collaborators

• Osijek University Hospital: lead
• Josip Juraj Strossmayer University of Osijek: collaborator

Study Sites (1)

Klinički bolnički centar Osijek (University Hospital Center Osijek)

Osijek, 31000, Croatia

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Vlasta Oršić Frič, MD

  University Hospital Center Osijek

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: May 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-10

Locations

CR (1)