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

NCT03710486 | Completed Results

• 3 other identifiers: Vedolizumab-5047U1111-1218-0768TAK-VDZ-2018-01
• Study Type: observational
• Target: 409
• Locations: 2 countries
• Sites: 26

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.

Conditions

Colitis, Ulcerative; Crohn Disease

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (30)

• Percentage of Participants With One or More Treatment Intensifications for CD Participants

  Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

  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)

• Percentage of Participants With One or More Treatment Intensifications for UC Participants

  Index treatment is the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. Dose intensification was performed by shortening the interval between doses in most cases in all the subgroups.

  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)

• Number of Participants With Reasons for Treatment Modifications in CD Participants

  Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Number of Participants With Reasons for Treatment Modifications in UC Participants

  Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Percentage of Participants Who Discontinued Index Therapy for CD Participants

  Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Percentage of Participants Who Discontinued Index Therapy for UC Participants

  Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Number of Participants Who Discontinue Index Treatment in Vedolizumab Cohort and Initiated Second-line Biologic Within 6 Months Post-index Treatment Discontinuation

  Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Time to Switching for Vedolizumab Participants

  Time to switching was defined as time from index treatment initiation until a participant initiated another biologic treatment (Vedolizumab, infliximab, adalimumab, or golimumab \[UC only\], tofacitinib, certolizumab and ustekinumab). Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Time to Discontinuation for CD Participants

  Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Time to Discontinuation for UC Participants

  Time to discontinuation was defined as time from index treatment initiation until participant discontinued index treatment without switching to another biologic therapy. Time to discontinuation was estimated with Kaplan-Meier method adjusted by PS-IPTW. Index treatment is defined as the first or second line treatment with vedolizumab or other biologics. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  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)

• Percentage of Participants With Clinical Response at 14 Weeks for CD Participants

  Clinical response in CD participants was evaluated using Harvey-Bradshaw index (HBI) scale. HBI scale consisted 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 was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score less than or equal to (\<=) 4 or reduction of greater than or equal to (\>=) 3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  At 14 weeks post-index (assessment time window 10 to 18 weeks)

• Percentage of Participants With Clinical Response at 52 Weeks for CD Participants

  Clinical response in CD participants was evaluated using HBI scale. HBI scale consisted 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 was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical response was defined as HBI score of \<=4 or reduction of \>=3 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  At 52 weeks post-index (assessment time window 46 to 58 weeks)

• Percentage of Participants With Clinical Response at 14 Weeks for UC Participants

  Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical response was defined as partial mayo score of less than (\<) 4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window 10 to 18 weeks)

• Percentage of Participants With Clinical Response at 52 Weeks for UC Participants

  Clinical response in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. The clinical response was defined as partial mayo score of \<4 or reduction of \>= 2 points in scores from index date or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 46 to 58 weeks)

• Percentage of Participants With Clinical Remission at 14 Weeks for CD Participants

  Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted 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 was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window 10 to 18 weeks)

• Percentage of Participants With Clinical Remission at 52 Weeks for CD Participants

  Clinical remission in CD participants was evaluated using HBI scale. HBI scale consisted 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 was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. Clinical remission was defined as HBI score of \<=4 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 46 to 58 weeks)

• Percentage of Participants With Clinical Remission at 14 Weeks for UC Participants

  Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 10 to 18 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window 10 to 18 weeks)

• Percentage of Participants With Clinical Remission at 52 Weeks for UC Participants

  Clinical remission in UC participants was evaluated using partial mayo score. Partial mayo score consisted of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3. These scores were summed to give a total score range of 0 to 9. Where, higher scores indicate more severe disease. Clinical remission was defined as partial mayo score of \<2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 46 to 58 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 46 to 58 weeks)

• Percentage of Participants With Biochemical Remission Based on C-reactive Protein (CRP) at 14 Weeks for CD Participants

  Biochemical remission based on CRP was defined as CRP level of \<5 milligram per liter (mg/L). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside greater than (\>) 0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window >0 to 38 weeks)

• Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for CD Participants

  Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Biochemical Remission Based on CRP at 14 Weeks for UC Participants

  Biochemical remission based on CRP was defined as CRP level \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window >0 to 38 weeks)

• Percentage of Participants With Biochemical Remission Based on CRP at 52 Weeks for UC Participants

  Biochemical remission based on CRP was defined as CRP level of \<5 mg/L. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Biochemical Remission Based on Fecal Calprotectin (FCP) at 14 Weeks for CD Participants

  Biochemical remission based on FCP was defined as FCP level of \<250 microgram per gram (mcg/g). Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window >0 to 38 weeks)

• Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for CD Participants

  Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Biochemical Remission Based on FCP at 14 Weeks for UC Participants

  Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside \>0 to 38 weeks time window was considered for 14 weeks assessment and were reported in this outcome measure.

  At 14 weeks post-index (assessment time window >0 to 38 weeks)

• Percentage of Participants With Biochemical Remission Based on FCP at 52 Weeks for UC Participants

  Biochemical remission based on FCP was defined as FCP level of \<250 mcg/g. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Endoscopic Response at 52 Weeks for CD Participants

  Endoscopic response for CD participants was evaluated using simple endoscopic index for Crohn's disease (SES-CD) score. SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was 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 was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD score \<=2 or based on physician assessment (for UC and CD both). SES-CD score at index date \>0 relative difference was calculated (100\*\[Index date-52 weeks assessment\]/Index date) and relative difference of \>= 50% was considered response. Index date was defined as the date when vedolizumab or other biologic treatment was initiated.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Endoscopic Response at 52 Weeks for UC Participants

  Endoscopic response in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Endoscopic Remission at 52 Weeks for CD Participants

  Endoscopic remission for CD participants was evaluated using SES-CD score. The SES-CD evaluated 4 endoscopic variables (ulcer size, percentage of the surface area that was 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 was the sum of values obtained for each segment. The SES-CD total was the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD score \<=2 or based on physician assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

• Percentage of Participants With Endoscopic Remission at 52 Weeks for UC Participants

  Endoscopic remission in UC participants is based on investigator assessment. Index date was defined as the date when vedolizumab or other biologic treatment was initiated. As pre-specified in the SAP, the data inside 28 to 76 weeks time window was considered for 52 weeks assessment and were reported in this outcome measure.

  At 52 weeks post-index (assessment time window 28 to 76 weeks)

Secondary Outcomes (6)

• Percentage of Participants With Adverse Events and Serious Adverse Events

  Index event period up to 6 months post-index treatment discontinuation

• Incidence Rate of Adverse Events and Serious Adverse Events

  Index event period up to 6 months post-index treatment discontinuation

• Percentage of Participants With Related Treatment Adverse Events and Related Treatment Serious Adverse Events

  Index event period up to 6 months post-index treatment discontinuation

• Incidence Rate of Related Treatment Adverse Events and Related Treatment Serious Adverse Events

  Index event period up to 6 months post-index treatment discontinuation

• Percentage of Participants With Infections, Serious Infections and Malignancies

  Index event period up to 6 months post-index treatment discontinuation

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Has a diagnosis of moderate to severe UC or CD documented in the medical chart.
• Received at least one dose of vedolizumab or other biologic (infliximab, adalimumab, or golimumab \[UC only\]) during the eligibility period.
• Received the biologic treatment as first-line or second line biologic for UC or CD.
• 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.

You may not qualify if:

• Received vedolizumab or another biologic as part of an interventional clinical trial ever in their lifetime (includes index treatment).
• Index treatment was another biologic therapy other than vedolizumab, infliximab, adalimumab, or golimumab (UC only).
• Initiated index treatment as combination therapy with two biologic agents.
• The biologic was prescribed for treatment of perianal disease.
• Received biologic therapy before the index period for a disease other than inflammatory bowel disease.
• Medical chart is unavailable.

Sponsors & Collaborators

• Takeda: lead

Study Sites (26)

Centro Hospitalar de Entre Douro e Vouga

Santa Maria da Feira, Aveiro District, 4520-211, Portugal

Location

Hospital Beatriz Angelo

Loures, Lisbon District, 2674-514, Portugal

Location

Hospital do Espirito Santo de Evora

Evora, 7000-811, Portugal

Location

Centro Hospitalar Universitario Lisboa Norte - Hospital de Santa Maria

Lisbon, 1649-028, Portugal

Location

Hospital Distrital de Santarem

Santarém, 2005-177, Portugal

Location

Hospital Universitari Son Espases

Palma, Balearic Islands, 07120, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Canary Islands, 38320, Spain

Location

Hospital Universitario de Leon

León, Castille and León, 24071, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Castille and León, 37007, Spain

Location

Hospital Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitari Parc Tauli

Barcelona, Catalonia, 08208, Spain

Location

Hospital de Sant Joan Despi - Moises Broggi

Barcelona, Catalonia, 08970, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital de La Princesa

Madrid, Madrid, 28006, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario de La Paz

Madrid, Madrid, 28046, Spain

Location

Hospital Universitario Puerta de Hierro

Madrid, Madrid, 28222, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencia, 03010, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital de Manises

Valencia, Valencia, 46940, Spain

Location

Related Publications (1)

• 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.

  PMID: 38658485 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 18, 2018
• Study Start: February 19, 2019
• Primary Completion: August 23, 2021
• Study Completion: February 21, 2022
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

PT (5); ES (21)