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 (EVOLVE-IBERIA)

Takeda

Status: Completed

Conditions: Colitis, Ulcerative; Crohn Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03710486

TAK-VDZ-2018-01 (Other Identifier)

Vedolizumab-5047

U1111-1218-0768 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to describe treatment patterns associated with first-line and second line biologic use (vedolizumab or other biologic) and to describe the real-world clinical effectiveness of the use (first-line and second line) vedolizumab versus other biologics at least 6 months post-treatment initiation.

Full description

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 participants in each treatment cohort. All participants will be enrolled into two observational groups:

• Cohort 1: Vedolizumab
• Cohort 2: Other Biologics

The data for participants will be collected in two main periods:

• Pre-index Event Period: From the data of diagnosis of UC/CD until one day prior to the date when vedolizumab or other biologic treatment was initiated during the eligibility period.
• Post-index Event Period: From the date when vedolizumab or other biologic treatment was initiated during the eligibility period until the earliest of 6 months (post-index treatment discontinuation, death of participants, lost-to-follow up, or date of chart abstraction initiation.

This multi-center trial will be conducted in Spain and Portugal. The overall time for data collection in the study will be approximately 12 months and the overall duration of the study is approximately 24 months.

Enrollment: 409 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

409 participants in 2 patient groups

Cohort 1: Vedolizumab

Description:

Participants diagnosed with UC or CD, who have initiated vedolizumab treatment between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index vedolizumab treatment initiation during the eligibility period, and then from date of index vedolizumab treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when vedolizumab treatment was initiated.

Cohort 2: Other Biologic

Description:

Participants diagnosed with UC or CD, who have initiated other biologic treatment (infliximab, adalimumab, or golimumab \[UC only\]) between January 2017 until date of site initiation from the 25 participating sites will be observed from the date of UC or CD diagnosis until one day prior to the date of index other biologic treatment initiation during the eligibility period, and then from date of index other biologic treatment initiation until the earliest of 6 months (post-index treatment discontinuation, death of participant, lost-to-follow up, or date of chart abstraction). Index date is defined as the date when other biologic treatment was initiated.