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

Crohn Disease Clinical Trial

— EVOLVE-IBERIA  

Official title:

Vedolizumab and Anti-TNFs Outcomes in Real-World Biologic Ulcerative Colitis and Crohn's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710486
• Other study ID #: Vedolizumab-5047
• Secondary ID: U1111-1218-0768T
• Status: Completed
• Start date: February 19, 2019
• Est. completion date: February 21, 2022

Study information

• Verified date: June 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: February 21, 2022
• Est. primary completion date: August 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer

Locations

Country	Name	City	State
Portugal	Hospital do Espirito Santo de Evora	Evora
Portugal	Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria	Lisboa
Portugal	Hospital Beatriz Angelo	Loures	Lisboa
Portugal	Centro Hospitalar de Entre Douro e Vouga	Santa Maria da Feira	Aveiro
Portugal	Hospital Distrital de Santarem	Santarem
Spain	Hospital General Universitario de Alicante	Alicante	Comunidad Valenciana
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Cataluna
Spain	Hospital de Sant Joan Despi - Moises Broggi	Barcelona	Cataluna
Spain	Hospital Universitari Parc Tauli	Barcelona	Cataluna
Spain	Hospital Vall d'Hebron	Barcelona	Cataluna
Spain	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Cataluna
Spain	Hospital Universitario de Leon	Leon	Castilla Y Leon
Spain	Hospital Clinico San Carlos	Madrid	Comunidad De Madrid
Spain	Hospital de La Princesa	Madrid	Comunidad De Madrid
Spain	Hospital General Universitario Gregorio Maranon	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 Universitario Central de Asturias (HUCA)	Oviedo	Asturias
Spain	Hospital Universitari Son Espases	Palma	Islas Baleares
Spain	Hospital de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y Leon
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital Clinico Universitario de Valencia	Valencia	Comunidad Valenciana
Spain	Hospital de Manises	Valencia	Comunidad Valenciana
Spain	Hospital Universitario y Politecnico La Fe	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Change in Dose and Frequency of Dose Intervals		From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Primary	Number of Participants With Treatment Modifications	Reasons for treatment modification will be related to adverse event (AE) versus related to disease management.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Primary	Number of Participants With Non-biological Concomitant Drug Treatment	Concomitant drug treatment will include prescribed non-biological drug therapy during post-index period. Index date is defined as the date when vedolizumab or other biologics treatment was initiated.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Primary	Number of Participants who Discontinued Index Therapy		From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Primary	Number of Participants who Discontinued Index Therapy With Subsequent Implementation of Another Biologic Therapy	Another biologic therapy will include either vedolizumab, infliximab, adalimumab, or golimumab (UC only), tofacitinib, certolizumab and ustekinumab.	From the index date up to treatment discontinuation, death, loss to follow up, or date of chart abstraction initiation (approximately 6 months post index date)
Primary	Time to Switching	Time to switching is defined as time from index treatment initiation until a participant initiates another biologic treatment (vedolizumab, infliximab, adalimumab, or golimumab [UC only], tofacitinib, certolizumab and ustekinumab).	From index date up to initiation of another biological treatment (approximately 6 months post index date)
Primary	Time to Discontinuation	Time to discontinuation is defined as time from index treatment initiation until participant discontinues index treatment without switching to another biologic therapy.	From index date up to discontinuation of index treatment without switching to another biologic therapy (approximately 6 months post index date)
Primary	Change From Baseline in Mayo Score at Month 6	Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool pattern, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Partial Mayo score consists of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicates more severe disease.	Baseline and Month 6 post-index date
Primary	Change From Baseline in Simple Endoscopic Index for Crohn's Disease (SES-CD) at Month 6	The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Baseline and Month 6 post-index date
Primary	Change From Baseline in Harvey Bradshaw Index (HBI) Score at Month 6	HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.	Baseline and Month 6 post-index date
Primary	Change From Baseline in Crohn's disease active index (CDAI) Score at Month 6	CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general well being, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease.	Baseline and Month 6 post-index date
Primary	Number of Participants With Change From baseline in C-reactive Protein (CRP) Level		Baseline and Month 6 post-index date
Primary	Number of Participants With Change From Baseline in Erythrocyte Sedimentation Rate (ESR) Level		Baseline and Month 6 post-index date
Primary	Number of Participants With Change From Baseline in Fecal Calprotectin (FCP) Level		Baseline and Month 6 post-index date
Primary	Number of Participants With Change From Baseline in Endoscopic Findings		Baseline and Month 6 post-index date
Secondary	Change From Baseline in Mayo Score at Month 12	Mayo score is an instrument designed to measure disease activity of UC. Complete Mayo score consists of 4 sub-scores: stool pattern, most severe rectal bleeding of the day, endoscopic findings and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 12. Partial Mayo score consists of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicates more severe disease.	Baseline and Month 12 post-index date
Secondary	Change From Baseline in SES-CD at Month 12	The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Baseline and Month 12 post-index date
Secondary	Change From Baseline in HBI Score at Month 12	HBI score is used to measure the disease activity of CD. It consists of clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools per day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score is the sum of individual parameters. The score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on the number of liquid stools, where higher scores indicating more severe disease.	Baseline and Month 12 post-index date
Secondary	Change From Baseline in CDAI Score at Month 12	CDAI assesses CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranges from 0 to 600 points. Higher score indicates more severe disease. HBI consists of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicates more severe disease.	Baseline and Month 12 post-index date
Secondary	Number of Participants with Change from Baseline in CRP Level, ESR Level, and FCP Level at Month 12		Baseline and Month 12 post-index date
Secondary	Number of Participants with Change From Baseline in Endoscopic Findings		Baseline and Month 12 post-index date
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Non-Treatment Related Events		Baseline up to Month 6 post-index date
Secondary	Number of Participants With Non-serious Adverse Events and Serious Adverse Events (SAEs) Related to Treatment		Baseline up to Month 6 post-index date
Secondary	Number of Participants With Treatment Alterations due to AEs	Treatment alterations include the factors like treatment withdrawn, treatment reduced, treatment delayed or treatment increased.	Baseline up to Month 6 post-index date
Secondary	AE Duration	AE duration is defined as date of onset of an AE till date of resolution.	From start of an AE up to AE resolution (Approximately up to 6 months)
Secondary	Number of Participants with AE Outcome		Baseline up to Month 6 post-index date