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Colitis, UlcerativeGEVOLNCT03378388

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

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 13 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
How many people
29 participants
Where
13 sitesFrance
Study dates
13 Feb 2018to 15 Feb 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Suffering from active disease of UC or CD according to the investigator's judgment.
  • 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.
  • Meeting the same criteria as those described at the pre-screening.
  • Prescription of vedolizumab during consultation.
  • Able to be followed a priori over a period of 24 months.

Who cannot join

  • 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).
  • Participation in an interventional study (but not in another non-interventional study).
  • Unclassified colitis.
  • Stomy.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

France13 sites

  • Centre Hospitalier Cote Basque

    Bayonne

  • Ch de Blois

    Blois

  • Clinique du palais

    Grasse

  • Ghef Ch Marne La Vallee

    Jossigny

  • Ctre Hosp St Joseph Et St Luc

    Lyon

  • Hopital Edouard Herriot

    Lyon

  • Hopital Saint Eloi-Chru Montpellier

    Montpellier

  • Ch Lyon Sud

    Pierre-Bénite

  • Polyclinique Cote Basque Sud

    Saint-Jean-de-Luz

  • HOPITAL NORD-CHU de SAINT-ETIENNE

    Saint-Priest-en-Jarez

  • Clinique Ambroise Pare

    Toulouse

  • HOPITAUX DE BRABOIS-CHRU de NANCY

    Vandœuvre-lès-Nancy

  • Gh mutualiste les portes du sud

    Vénissieux

Other trials in France

About this study

Official title: 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.

Read the 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.

Keywords
Drug therapy
Medical subject headings
Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03378388
Study groupRoleWhat they receive
VedolizumabParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Complete Steroid-free Clinical Remission at 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.

    Measured: Month 24

Secondary outcomes (23)

  1. Number of Participants with Complete Steroid-free Remission at Month 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.

    Measured: Months 6, 12, and 18

  2. Duration of Treatment in Participants Treated with Vedolizumab

    Measured: Baseline up to Month 24

  3. Number of Participants who had Treatment Failure When Treated With Vedolizumab

    Measured: Baseline up to Month 24

  4. Number of Treatment Lines in Participants Treated with Vedolizumab

    Measured: Baseline up to Month 24

  5. Number of Naïve Participants Ineligible to Anti TNF Alpha

    Measured: Baseline up to Month 24

  6. Number of Non-naïve Participants Ineligible to Anti TNF Alpha

    Measured: Baseline up to Month 24

  7. Number of Participants who Experience at Least one Treatment-emergent Adverse Event (TEAE)

    Measured: Baseline up to Month 24

  8. Number of Participants with Non-serious Adverse Drug Reactions (ADRs)

    Measured: Baseline up to Month 24

  9. Number of Participants with Special Situation Report (SSR)

    Measured: Baseline up to Month 24

  10. Number of Participants with Product Quality Issues

    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.

    Measured: Baseline up to Month 24

  11. Number of Participants with Markedly Abnormal Laboratory Values

    Measured: Baseline up to Month 24

  12. Patient Reported Outcomes (PRO) 1: Quality of Life

    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.

    Measured: Months 6, 12, 18 and 24

  13. PRO 2: Number of Participants who met Item 1 and 2 on the Partial Mayo Score and Item 2 and 3 on the HBI

    Measured: Months 6, 12, 18 and 24

  14. Number of Participants With Concordance Between PRO-2 and Physicians Answers

    Measured: Baseline up to 24 Months

  15. Number of Participants who had Relapses

    Number of participants with relapses will be collected through hospital reports which will be provided by the investigator.

    Measured: Baseline up to Month 24

  16. Number of Participants who had Surgery

    Number of participants with surgery will be collected through hospital reports which will be provided by the investigator.

    Measured: Baseline up to Month 24

  17. Number of Participants who had Complications due to Adverse Events (AEs)

    Measured: Baseline up to Month 24

  18. Number of Participants who had Hospitalizations

    Number of participants with hospitalizations will be collected through hospital reports which will be provided by the investigator.

    Measured: Baseline up to Month 24

  19. Number of Participants who had Absenteeism

    Number of participants with absenteeism will be collected by the participants using a self-administered questionnaire.

    Measured: Baseline up to Month 24

  20. Number of Participants with Vedolizumab Effectiveness on Extra-intestinal Manifestations or Fistula

    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.

    Measured: Baseline up to Month 24

  21. Number of Participants with Mucosal Healing Having Undergone Endoscopy

    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.

    Measured: Months 6, 12, 18 and 24

  22. Percentage of Physicians Following the French National Consensus for the Management of IBD into Clinical Practice

    Percentage of physicians following the French national consensus for the management of IBD into clinical practice.

    Measured: Baseline up to Month 24

  23. Number of Participants with Comorbodities, Previous Line of Therapy and Concomitant Treatments

    Measured: Baseline up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start13 Feb 2018
  3. Primary completion15 Feb 2019
  4. Study completion15 Feb 2019

Why it stopped: Business Decision; Insufficient Enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378388
Sponsor's protocol ID
Vedolizumab-5039
Other IDs
U1111-1203-0268
Acronym
GEVOL
Status last verified
Oct 2020
First submitted
11 Dec 2017
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative and Crohn Disease, run by Takeda at 13 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Business Decision; Insufficient Enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Complete Steroid-free Clinical Remission at Month 24 (time frame: Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.

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