A Study to Observe Vedolizumab and Anti-tumour Necrosis Factors (Anti-TNFs) Outcomes in Real-world Biologic Ulcerative Colitis (UC) and Crohn's Disease (CD) Participants

Launched by TAKEDA · Oct 16, 2018

Keywords

ClinConnect Summary

This is a retrospective, non-interventional study of participants with CD or UC. The study will review the medical charts of participants who have initiated the first or second line treatment with vedolizumab or another biologic agent (infliximab, adalimumab, or golimumab \[UC only\]) (index event) during the eligibility period to evaluate the treatment effectiveness, treatment patterns, health care utilization and safety of vedolizumab, and to provide the real-world treatment landscape with anti-TNF alpha therapies.

The study will enroll approximately 400 participants, with 200 participan...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has a diagnosis of moderate to severe UC or CD documented in the medical chart.
• • 2. Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab \[UC only\]) during the eligibility period.
• • 3. Received the biologic treatment as first-line or second line biologic for UC or CD.
• • 4. Has a minimum of six months of follow-up between date of starting biologic therapy (index event) and the date of completion of the participant pre-selection registry.
• Exclusion Criteria:
• • 1. Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment).
• • 2. Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only).
• • 3. Initiated index treatment as combination therapy with two biologic agents.
• • 4. The biologic was prescribed for treatment of perianal disease.
• • 5. Received biologic therapy before the index period for a disease other than inflammatory bowel disease.
• • 6. Medical chart is unavailable.