Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Conditions
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.
Interventions
None listed
Sponsors
Josip Juraj Strossmayer University of Osijek
Osijek University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| Rate of Hospitalizations After Switching to Vedolizumab SC | Up to 12 months from switch | Hospitalizations due to inflammatory bowel disease activity or complications will be taken into account. |
| Rate of Surgery After Switching to Vedolizumab SC | Up to 12 months from switch | Surgery due to inflammatory bowel disease activity or complications will be taken into account. |
| Rate of Treatment Change After Switching to Vedolizumab SC | 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. |
Countries
Croatia
Outcome results
None listed