None listed
Conditions
Brief summary
This study will look at how people with ulcerative colitis (UC) respond to treatment with the medicine vedolizumab. It will take place across several centres and follow people in a real-world setting. The focus is on whether vedolizumab can help achieve “transmural response” or “transmural healing,” which means improvement and healing throughout the full thickness of the bowel wall, not just the inner lining. Participants will first receive vedolizumab through intravenous (IV) infusions to induce remission, and then continue with ongoing maintenance therapy. Ultrasound scans of the bowel (intestinal ultrasound, or IUS) will be used to measure changes and healing over time. The main aim is to understand how effective vedolizumab is at achieving deeper levels of healing in people with ulcerative colitis.
Interventions
Standard of care vedolizumab
Frequency of Observation: Screening 0 (-4 Weeks to week 0 - prior to the initiation of vedolizumab), week 2 (optional), week 6, week 12 and week 36 post the initiation of vedolizumab.
Information collected during routine care appts and an additional observation at week 2 (optional):
Medical history (significant co-morbidities), IBD history (surgeries, past IBD medications), current IBD history - This information will be collected from medical records and participa
Standard of care vedolizumab Frequency of Observation: Screening 0 (-4 Weeks to week 0 - prior to the initiation of vedolizumab), week 2 (optional), week 6, week 12 and week 36 post the initiation of vedolizumab. Information collected during routine care appts and an additional observation at week 2 (optional): Medical history (significant co-morbidities), IBD history (surgeries, past IBD medications), current IBD history - This information will be collected from medical records and participants are not actively involved Intestinal ultrasound reports (GIUS) during routine care - approximately 20 minutes during routine care appointment Surveys: Adverse events form, Fatigue -FACIT fatigue scale, Quality of life - SIBDQ, and IBD symptoms - Simple Clinical Colitis Activity Index (SCCAI) and Partial mayo- Surveys will take participants approximately 15 minutes in total/ observation timepoint.
Sponsors
Central Adelaide Local Health Network
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Equal to or more than 18 years of age at the time of study consent. • Prescribed vedolizumab for induction of remission during routine care. • Have evidence of active inflammation (BWT more than 3.0 mm and positive Doppler signal) in at least one segment of visualized colon by IUS. • Biologic-naïve or have previous exposure to no more than one advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their UC. • For participants on 5-ASA or thiopurines prior to enrolment, they may continue stable dose (initiated at least 3 weeks prior to baseline). • Participants must be able to understand and agree to the informed consent approved by the HREC. They should have read and comprehended the Participant Information and Consent Form (PICF), fully grasp the study requirements, and be willing to adhere to all study visits and assessments.
Exclusion criteria
• Diagnosis of indeterminate IBD or Crohn’s disease • Current or previous treatment with vedolizumab, etrolizumab, or natalizumab. • Previously exposed to 2 or more compounds of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their UC. • Change to oral corticosteroid therapy dosing within 2 weeks prior to enrolment or a corticosteroid dose of more than 50 mg of prednisone or equivalent at enrolment. • Significant medical or cognitive/ psychiatric comorbidities that will impact ability to participate fully in the study. • Previous extensive colonic resection or missing more than 2 segments out of 4 (right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, proctocolectomy or Ileoanal pouch surgery. • Positive stool test for Clostridioides difficile infection (indicated by a positive toxin result). • Presence of other significant systemic or opportunistic infections, any significant extraintestinal infection, or a recurring infection within 6 months of enrolment • History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant’s ability to comply with the study procedures. • Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab. • Unable to provide informed consent or engage in study protocol.
Outcome results
None listed