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

NCT ID: NCT03710486

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 409 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2022-02-21

Brief Summary

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.

Detailed 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.

Conditions

Colitis, Ulcerative; Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Cohort 1: Vedolizumab

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.

No interventions assigned to this group

Cohort 2: Other Biologic

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Centro Hospitalar de Entre Douro e Vouga

Santa Maria da Feira, Aveiro District, Portugal

Hospital Beatriz Angelo

Loures, Lisbon District, Portugal

Hospital do Espirito Santo de Evora

Evora, , Portugal

Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria

Lisbon, , Portugal

Hospital Distrital de Santarem

Santarém, , Portugal

Hospital Universitari Son Espases

Palma, Balearic Islands, Spain

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, Spain

Hospital Universitario de Leon

León, Castille and León, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitari Parc Tauli

Barcelona, Catalonia, Spain

Hospital de Sant Joan Despi - Moises Broggi

Barcelona, Catalonia, Spain

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, Spain

Hospital de La Princesa

Madrid, Madrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, Spain

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario de La Paz

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Madrid, Spain

Hospital de Navarra

Pamplona, Navarre, Spain

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, Spain

Hospital General Universitario de Alicante

Alicante, Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Valencia, Spain

Hospital de Manises

Valencia, Valencia, Spain

Countries

Portugal; Spain

References

Yarur A, Mantzaris GJ, Wang S, Adsul S, Kamble P, Cook E, Sajeev G, Guerin A, Bressler B. Stratified Patient Profiling for Vedolizumab Effectiveness in Crohn's Disease: Identifying Optimal Subgroups for Enhanced Treatment Response in the EVOLVE Study. Adv Ther. 2024 Jun;41(6):2324-2341. doi: 10.1007/s12325-024-02825-w. Epub 2024 Apr 24.

Reference Type: DERIVED

PMID: 38658485 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1218-0768

Identifier Type: REGISTRY

Identifier Source: secondary_id

TAK-VDZ-2018-01

Identifier Type: OTHER

Identifier Source: secondary_id

Vedolizumab-5047

Identifier Type: -

Identifier Source: org_study_id