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NCT Number: NCT05504915

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinički bolnički centar Osijek (University Hospital Center Osijek)

Osijek, 31000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Change in Mean Serum Vedolizumab Through Concentration After Switching from Vedolizumab IV to Vedolizumab SC

    Time frame: Up to 12 months from switch

  2. Percentage of Participants in Remission After Switching to Vedolizumab SC

    Time frame: Up to 12 months from switch

    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).

  3. Rate of Hospitalizations After Switching to Vedolizumab SC

    Time frame: Up to 12 months from switch

    Hospitalizations due to inflammatory bowel disease activity or complications will be taken into account.

  4. Rate of Surgery After Switching to Vedolizumab SC

    Time frame: Up to 12 months from switch

    Surgery due to inflammatory bowel disease activity or complications will be taken into account.

  5. Rate of Treatment Change After Switching to Vedolizumab SC

    Time frame: Up to 12 months from switch

    Treatment change is defined as start of corticosteroid therapy, switch to vedolizumab IV again or switch to another biologic or small molecule.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Collaborators

  • Josip Juraj Strossmayer University of Osijek

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 17, 2022
Registry last updated
Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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