Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Colitis, Ulcerative
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
Collaborators: name: Josip Juraj Strossmayer University of Osijek
First posted: 2022-08-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with UC or CD receiving vedolizumab treatment in accordance with the approved SmPC.

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.

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

Primary outcomes:
measure: Change in Mean Serum Vedolizumab Through Concentration After Switching from Vedolizumab IV to Vedolizumab SC
timeFrame: Up to 12 months from switch
measure: Percentage of Participants in Remission After Switching to Vedolizumab SC
timeFrame: Up to 12 months from switch
measure: Rate of Hospitalizations After Switching to Vedolizumab SC
timeFrame: Up to 12 months from switch
measure: Rate of Surgery After Switching to Vedolizumab SC
timeFrame: Up to 12 months from switch
measure: Rate of Treatment Change After Switching to Vedolizumab SC
timeFrame: Up to 12 months from switch
Secondary outcomes:
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Klinički bolnički centar Osijek (University Hospital Center Osijek)
Study officials:
affiliation: University Hospital Center Osijek
name: Vlasta Oršić Frič, MD
role: PRINCIPAL_INVESTIGATOR
References: