Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients
Study ID: NCT03710486
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Centro Hospitalar de Entre Douro e Vouga, Santa Maria da Feira, Aveiro, Portugal
Hospital Beatriz Angelo, Loures, Lisboa, Portugal
Hospital do Espirito Santo de Evora, Evora, , Portugal
Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria, Lisboa, , Portugal
Hospital Distrital de Santarem, Santarem, , Portugal
Hospital Universitario Central de Asturias (HUCA), Oviedo, Asturias, Spain
Hospital Universitario de Leon, Leon, Castilla Y Leon, Spain
Hospital Universitario de Salamanca, Salamanca, Castilla Y Leon, Spain
Hospital Vall d'Hebron, Barcelona, Cataluna, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, Cataluna, Spain
Hospital Universitari Parc Tauli, Barcelona, Cataluna, Spain
Hospital de Sant Joan Despi - Moises Broggi, Barcelona, Cataluna, Spain
Hospital Universitari de Girona Doctor Josep Trueta, Girona, Cataluna, Spain
Hospital de La Princesa, Madrid, Comunidad De Madrid, Spain
Hospital General Universitario Gregorio Maranon, Madrid, Comunidad De Madrid, Spain
Hospital Clinico San Carlos, Madrid, Comunidad De Madrid, Spain
Hospital Universitario 12 de Octubre, Madrid, Comunidad De Madrid, Spain
Hospital Universitario de La Paz, Madrid, Comunidad De Madrid, Spain
Hospital Universitario Puerta de Hierro, Madrid, Comunidad De Madrid, Spain
Hospital General Universitario de Alicante, Alicante, Comunidad Valenciana, Spain
Hospital Clinico Universitario de Valencia, Valencia, Comunidad Valenciana, Spain
Hospital Universitario y Politecnico La Fe, Valencia, Comunidad Valenciana, Spain
Hospital de Manises, Valencia, Comunidad Valenciana, Spain
Hospital Universitari Son Espases, Palma, Islas Baleares, Spain
Hospital Universitario de Canarias, Santa Cruz de Tenerife, Islas Canarias, Spain
Hospital de Navarra, Pamplona, Navarra, Spain
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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