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ULCERATIVE COLITISDETECTNCT02878083

Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

A study testing VEDOLIZUMAB and ADALIMUMAB in people with ULCERATIVE COLITIS, run by Nantes University Hospital at 4 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 main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ULCERATIVE COLITIS
What is being tested?
VEDOLIZUMAB and ADALIMUMAB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
4 sitesFrance
Study dates
11 Jan 2017to 1 Jan 2021
Phase
Interventional
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

Who may be able to join

  • Patients with moderate to severe UC defined by an overall Mayo score ≥ 5 and an endoscopic sub-score ≥ 2 points and rectal bleeding score ≥ 1 point
  • Extension > 15 cm from the anal margin
  • Requiring treatment with biotherapy and meeting the indications for the treatment
  • Affiliated with a social security scheme

Who cannot join

  • Crohn's disease or unclassified colitis
  • Severe acute colitis
  • Requirement for immediate surgical treatment
  • Previous treatment with vedolizumab or anti-TNF-α
  • Contraindication to the use of vedolizumab or an anti-TNF-α agent
  • Contraindication to the use of adalimumab
Show all 12Show fewer
  • Corticosteroid therapy > 20 mg/day
  • Corticosteroid therapy started within the previous two weeks
  • Conventional Immunosppressor started within the previous month
  • Colonic dysplasia or known cancer
  • Likelihood to refuse two rectosigmoidoscopies, performed eighteen weeks apart
  • Pregnant or lactating women

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • Chu Angers

    Angers

  • Chd Vendee

    La Roche-sur-Yon

  • Chu Nantes

    Nantes

  • Chu Rennes

    Rennes

Other trials in France

About this study

The main objective of this project is to demonstrate the feasability of an endomicroscopic biomarker of efficacy of vedolizumab and adalimumab, in Ulcerative colitis (UC) by coupling vedolizumab to a fluorescent component, FITC (Fluorescein isothiocyanate) , and adalimumab to rhodamine.

This project should allow the development of a biomarker of therapeutic efficacy for vedolizumab and adalimumab that can be used in a single time-frame in vivo in humans, while respecting manufacturing standards and Good manufacturing procedures.

Read the detailed description

Patients will be recruited before initiation of vedolizumab injections. The schedule for vedolizumab infusions will corresponding to the protocol follow-up visits (Week 0, W2, W6, W14, W22), and flexible sigmoidoscopy appointments will be performed at Week 0 and 22.

For responder patients, the end of the study will occured two weeks after the last vedolizumab infusion (W24).

At week 22, nonresponder patients to vedolizumab may be treated by adalimumab in the absence of contraindication and depending on the decision of the physician responsible for the patient. Patients will be treated every two weeks during 8 weeks. The protocol follow up will end 2 weeks after the fourth adalimumab injection.

During W0 and W22, colon biopsies will be collected. Blood samples will be collected on W0, W2, W6, W14, W22 (and W30 for non responder).

Being tested
VEDOLIZUMAB, ADALIMUMAB
Keywords
vedolizumab,, confocal endomicroscopy, biomarker, ULCERATIVE COLITIS
Medical subject headings
Colitis, Ulcerative

What participants receive

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

  • VEDOLIZUMABDrug

    Also called entyvio

    Infusion at week 0 week 2 week 6 week 14 for all patients Infusion at week 22 for responder patient only

  • ADALIMUMABDrug

    Also called HUMIRA

    For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28

Study groups in NCT02878083
Study groupRoleWhat they receive
VEDOLIZUMABExperimental300 mg IV
Receives: Drug: VEDOLIZUMAB; Drug: ADALIMUMAB

What is being measured

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

  1. Demonstrate the feasibility of an ex vivo labeling of intestinal immune cells with a combination of two markers: vedolizumab-FITC and adalimumab-Alexa Fluor 647

    Presence of fluorescent cells by Cellvizio® examination field for each of the antibodies: FITCcoupled vedolizumab and Alexa Fluor 647-coupled adalimumab at week 0 for all the patients.

    Measured: week 0

Secondary outcomes (11)

  1. Quantify, ex vivo, the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa of patients with moderate to severe UC that are associated with clinical remission at week 22 (W22) after the initiation of treatment with vedolizumab.

    -Number of fluorescent cells by Cellvizio® examination field for each of the antibodies: FITC-coupled vedolizumab and Alexa Fluor 647-coupled adalimumab / Score of clinical response assessment

    Measured: Week 22

  2. Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of clinical response induced by treatment with a standard dose of vedolizumab

    • Number of fluorescent cells / Mayo clinic sub-score

    Measured: week 22

  3. Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of endoscopic remission induced by treatment with a standard dose of vedolizumab

    • Number of fluorescent cells / Geboes sub-score

    Measured: week 22

  4. Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of histologic remission induced by treatment with a standard dose of vedolizumab

    • Number of fluorescent cells / Mayo endoscopic sub-score,

    Measured: week 22

  5. Evaluate the association between the number of cells labeled with FITC-coupled vedolizumab in the intestinal mucosa and the rate of clinical response induced by treatment with a standard dose of vedolizumab

    • Number of fluorescent cells / rectal bleeding score

    Measured: week 22

  6. Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of clinical response at w30 to adalimumab

    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / Mayo clinic sub-score

    Measured: from week 0 to week 30

  7. Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of endoscopic remission at w30 to adalimumab

    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / Mayo endoscopic sub-score,

    Measured: from week 0 to week 30

  8. Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of endoscopic remission at w30 to adalimumab

    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / Geboes sub-score

    Measured: from week 0 to week 30

  9. Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of clinical remission at w30 to adalimumab

    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / rectal bleeding score

    Measured: from week 0 to week 30

  10. Compare the number of positive immune cells FITC-coupled vedolizumab in the intestinal mucosa of patients with UC

    Average of Number of fluorescent cells FITC-coupled vedolizumab / patient

    Measured: week 0

  11. Compare the number of positive immune cells Alexa Fluor 647-coupled adalimumab in the intestinal mucosa of patients with UC

    Average of Number of fluorescent cells Alexa Fluor 647-coupled adalimumab/ patient

    Measured: week 0

Timeline

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

  1. First posted25 Aug 2016 (estimated)
  2. Study start11 Jan 2017
  3. Primary completionJan 2020
  4. Study completion1 Jan 2021

Why it stopped: the CELLVIZIO device required to analyse biopsy is available until september 2020

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02878083
Sponsor's protocol ID
RC15_0457
Acronym
DETECT
Status last verified
Feb 2023
First submitted
16 Aug 2016
Last updated
17 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Queneherve L, Trang-Poisson C, Fantou A, Flamant M, Durand T, Bouguen G, Bregeon J, Oullier T, Amil M, Dewitte M, Bardot S, Blandin S, Braudeau C, Vibet MA, Josien R, Neunlist M, Bourreille A. Confocal laser endomicroscopy as predictive biomarker of clinical and endoscopic efficacy of vedolizumab in ulcerative colitis: The DETECT study. PLoS One. 2024 Apr 2;19(4):e0298313. doi: 10.1371/journal.pone.0298313. eCollection 2024.

    PubMed 38564601

Questions about this trial

What is this clinical trial studying?

A study testing VEDOLIZUMAB and ADALIMUMAB in people with ULCERATIVE COLITIS, run by Nantes University Hospital at 4 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 4 inclusion and 12 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 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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: the CELLVIZIO device required to analyse biopsy is available until september 2020). 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?

Demonstrate the feasibility of an ex vivo labeling of intestinal immune cells with a combination of two markers: vedolizumab-FITC and adalimumab-Alexa Fluor 647 (time frame: week 0). 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 NCT02878083, which also lists 1 linked publication.

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 17 Feb 2023.

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