Clinical trial NCT03710486: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with moderate to severe UC or CD, and have initiated first or second line treatment with vedolizumab and other biologics between January 2017 and the date of site initiation.

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.

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.

Primary outcomes:
measure: Percentage of Participants With One or More Treatment Intensifications for CD Participants
timeFrame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Percentage of Participants With One or More Treatment Intensifications for UC Participants
timeFrame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Number of Participants With Reasons for Treatment Modifications in CD Participants
timeFrame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Number of Participants With Reasons for Treatment Modifications in UC Participants
timeFrame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Percentage of Participants Who Discontinued Index Therapy for CD Participants
timeFrame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Percentage of Participants Who Discontinued Index Therapy for UC Participants
timeFrame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation
timeFrame: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Time to Switching for Vedolizumab Participants
timeFrame: From the date of diagnosis of CD or UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Time to Discontinuation for CD Participants
timeFrame: From the date of diagnosis of CD (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Time to Discontinuation for UC Participants
timeFrame: From the date of diagnosis of UC (within previous 2 years) including index date until post-index treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
measure: Percentage of Participants With Clinical Response at 14 Weeks for CD Participants
timeFrame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
measure: Percentage of Participants With Clinical Response at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
measure: Percentage of Participants With Clinical Response at 14 Weeks for UC Participants
timeFrame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
measure: Percentage of Participants With Clinical Response at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
measure: Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants
timeFrame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
measure: Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
measure: Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants
timeFrame: At 14 weeks post-index (assessment time window 10 to 18 weeks)
measure: Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 46 to 58 weeks)
measure: Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants
timeFrame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
measure: Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants
timeFrame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
measure: Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants
timeFrame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
measure: Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants
timeFrame: At 14 weeks post-index (assessment time window >0 to 38 weeks)
measure: Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
measure: Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants
timeFrame: At 52 weeks post-index (assessment time window 28 to 76 weeks)
Secondary outcomes:
measure: Percentage of Participants With Adverse Events and Serious Adverse Events
timeFrame: Index event period up to 6 months post-index treatment discontinuation
measure: Incidence Rate of Adverse Events and Serious Adverse Events
timeFrame: Index event period up to 6 months post-index treatment discontinuation
measure: Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events
timeFrame: Index event period up to 6 months post-index treatment discontinuation
measure: Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events
timeFrame: Index event period up to 6 months post-index treatment discontinuation
measure: Percentage of Participants With Infections, Serious Infections and Malignancies
timeFrame: Index event period up to 6 months post-index treatment discontinuation
measure: Incidence Rate of Infections, Serious Infections and Malignancies
timeFrame: Index event period up to 6 months post-index treatment discontinuation
Other outcomes:
Locations:
city: Santa Maria da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga
state: Aveiro
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
state: Lisboa
city: Evora
country: Portugal
facility: Hospital do Espirito Santo de Evora
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria
city: Santarem
country: Portugal
facility: Hospital Distrital de Santarem
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
state: Asturias
city: Leon
country: Spain
facility: Hospital Universitario de Leon
state: Castilla Y Leon
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y Leon
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital Universitari Parc Tauli
state: Cataluna
city: Barcelona
country: Spain
facility: Hospital de Sant Joan Despi - Moises Broggi
state: Cataluna
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
state: Cataluna
city: Madrid
country: Spain
facility: Hospital de La Princesa
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
state: Comunidad De Madrid
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Comunidad De Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital de Manises
state: Comunidad Valenciana
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Islas Baleares
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Islas Canarias
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: