A Study to Assess the Effectiveness and Safety of Treatment With Vedolizumab in Adult Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real Life (GEVOL)

October 12, 2020 updated by: Takeda

Effectiveness and Safety of Treatment With Vedolizumab in Adult Patients With Ulcerative Colitis or Crohn's Disease in Real Life

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a prospective, non-interventional and pharmaco-epidemiological study of participants with IBD. The study will provide the real-life data of treatment effectiveness and safety of vedolizumab in adult participants with UC or CD.

The study will enroll approximately 300 participants. All participants will be enrolled in one observational group:

Vedolizumab

Data will be collected and observed for 24 months in the participants who will be freely chosen by physicians to prescribe vedolizumab at the end of consultation in the recruitment period.

This multi-center trial will be conducted in France. The overall time to participate in this study is 36 months, including participant's recruitment period of 12 months and treatment period of 24 months. Participants will make a minimum of 4 follow-up visits to the clinic in treatment period at Month 6, 12, 18, and 24.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • BAYONNE Cedex, France
        • Centre Hospitalier Côte Basque
      • Blois Cedex, France
        • CH DE BLOIS
      • Grasse, France
        • Clinique du Palais
      • Jossigny, France
        • Ghef Ch Marne La Vallee
      • Lyon Cedex 03, France
        • Hôpital Edouard Herriot
      • Lyon Cedex 07, France
        • Ctre Hosp St Joseph Et St Luc
      • Montpellier Cedex 5, France
        • Hopital Saint Eloi-Chru Montpellier
      • Pierre Benite Cedex, France
        • CH Lyon Sud
      • St Jean de Luz Cedex, France
        • Polyclinique Côte Basque Sud
      • St Priest En Jarez Cedex, France
        • HOPITAL NORD-CHU de SAINT-ETIENNE
      • Toulouse, France
        • Clinique Ambroise Pare
      • Vandoeuvre Les Nancy Cedex, France
        • HOPITAUX DE BRABOIS-CHRU de NANCY
      • Venissieux Cedex, France
        • Gh mutualiste les portes du sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who are biologically naive and are diagnosed with active disease of UC or CD according to investigator's judgement.

Description

Inclusion Criteria:

  1. Suffering from active disease of UC or CD according to the investigator's judgment.
  2. In failure or intolerant to a previous biologic treatment, or with contra-indication to anti-TNFalpha after failure of conventional treatments, regardless of the line of treatment.
  3. Meeting the same criteria as those described at the pre-screening.
  4. Prescription of vedolizumab during consultation.
  5. Able to be followed a priori over a period of 24 months.

Exclusion Criteria:

  1. With exclusion criteria for vedolizumab and any contra-indication to vedolizumab: hypersensitivity to the active substance or to any of its excipients, active severe infections, such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections such as progressive multifocal leukoencephalopathy (PML).
  2. Participation in an interventional study (but not in another non-interventional study).
  3. Unclassified colitis.
  4. Stomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Vedolizumab
Participants diagnosed with UC or CD, who fail or are intolerant to a previous biologic treatment or with contra-indication to anti-tumor necrosis factor alpha (TNF alpha) after failure of conventional treatments without exclusion except participant refusal, and were potentially eligible for a treatment with vedolizumab will be observed from the first prescription during consultation over a period of 24 months.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Complete Steroid-free Clinical Remission at Month 24
Time Frame: Month 24
Clinical remission is defined as Harvey Bradshaw-index (HBI) score less than or equal to (<=) 4 and partial mayo clinic score <=3. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is sum of individual parameters. Score ranges from minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores means more severe disease. Mayo score is an instrument designed to measure disease activity of UC and consists of 3 sub scores: stool frequency, rectal bleeding, and physician rating of disease activity, 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; where higher scores means more severe disease.
Month 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Complete Steroid-free Remission at Month 6, 12 and 18
Time Frame: Months 6, 12, and 18
Clinical remission is defined as HBI score <=4 and partial mayo clinic score <=3. HBI score is used to measure disease activity of CD. It consists of clinical parameters: general well-being (0-4), abdominal pain (0-3), number of liquid stools per day, abdominal mass (0-3), and complications (score 1 per item). Total score is sum of individual parameters. Score ranges from minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores means more severe disease. Mayo score is an instrument designed to measure disease activity of UC and consists of 3 sub scores: stool frequency, rectal bleeding, and physician rating of disease activity, 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; where higher scores means more severe disease.
Months 6, 12, and 18
Duration of Treatment in Participants Treated with Vedolizumab
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants who had Treatment Failure When Treated With Vedolizumab
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Treatment Lines in Participants Treated with Vedolizumab
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Naïve Participants Ineligible to Anti TNF Alpha
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Non-naïve Participants Ineligible to Anti TNF Alpha
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE)
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants with Non-serious Adverse Drug Reactions (ADRs)
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants with Special Situation Report (SSR)
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants with Product Quality Issues
Time Frame: Baseline up to Month 24
A product quality issue refers to defects related to the safety, identity, strength, quality, or purity of the product or with the physical characteristics, packaging, labelling, or design of the product.
Baseline up to Month 24
Number of Participants with Markedly Abnormal Laboratory Values
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Patient Reported Outcomes (PRO) 1: Quality of Life
Time Frame: Months 6, 12, 18 and 24
Participant's Quality of Life (PRO-1) will be measured by the inflammatory bowel disease questionnaire (IBDQ). The IBDQ is a 32-item questionnaire that measures 4 dimensions: bowel symptoms (10 items), emotional disorders (12 items), systemic symptoms (5 items), and social function (5 items). Each item is measured according to the Likert technique. Within dimensions, each question presents seven possible answers/points. Each domain score is the sum of 8 responses each ranging from 1 to 7, where 1 indicates worst function and 7 the best. The sub-score ranges from 8 to 56; a higher score indicating a better quality of life. Hence, the total score ranges from 32 to 224, with higher scores representing better quality of life.
Months 6, 12, 18 and 24
PRO 2: Number of Participants who met Item 1 and 2 on the Partial Mayo Score and Item 2 and 3 on the HBI
Time Frame: Months 6, 12, 18 and 24
Months 6, 12, 18 and 24
Number of Participants With Concordance Between PRO-2 and Physicians Answers
Time Frame: Baseline up to 24 Months
Baseline up to 24 Months
Number of Participants who had Relapses
Time Frame: Baseline up to Month 24
Number of participants with relapses will be collected through hospital reports which will be provided by the investigator.
Baseline up to Month 24
Number of Participants who had Surgery
Time Frame: Baseline up to Month 24
Number of participants with surgery will be collected through hospital reports which will be provided by the investigator.
Baseline up to Month 24
Number of Participants who had Complications due to Adverse Events (AEs)
Time Frame: Baseline up to Month 24
Baseline up to Month 24
Number of Participants who had Hospitalizations
Time Frame: Baseline up to Month 24
Number of participants with hospitalizations will be collected through hospital reports which will be provided by the investigator.
Baseline up to Month 24
Number of Participants who had Absenteeism
Time Frame: Baseline up to Month 24
Number of participants with absenteeism will be collected by the participants using a self-administered questionnaire.
Baseline up to Month 24
Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula
Time Frame: Baseline up to Month 24
Number of participants who had effectiveness of vedolizumab on extra-intestinal manifestations or fistula will be assessed. Extra-intestinal manifestations of pathology such as skin, articular, ocular, metabolic, bone, hepato-pancreato-biliary, neurological, cardiovascular diseases and complications related to anal fistula is planned to be assessed.
Baseline up to Month 24
Number of Participants with Mucosal Healing Having Undergone Endoscopy
Time Frame: Months 6, 12, 18 and 24
Mucosal healing is defined either as the absence of any ulcer (Crohn's Disease Endoscopic Index of Severity [CDEIS] at 0) for CD participants and as a Mayo clinic endoscopic subscore <=1 for UC participants.
Months 6, 12, 18 and 24
Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice
Time Frame: Baseline up to Month 24
Percentage of physicians following the French national consensus for the management of IBD into clinical practice.
Baseline up to Month 24
Number of Participants with Comorbodities, Previous Line of Therapy and Concomitant Treatments
Time Frame: Baseline up to Month 24
Baseline up to Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Vedolizumab-5039
  • U1111-1203-0268 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammatory Bowel Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings