Trial record 4 of 45 for:    vedolizumab

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2016 by Nantes University Hospital
Sponsor:
Collaborators:
Takeda
Mauna Kea Technologies
Institut national de la santé et de la recherche médicale unité 913 FRANCE
Institut national de la santé et de la recherche médicale unité1064 FRANCE
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT02878083
First received: August 16, 2016
Last updated: August 19, 2016
Last verified: August 2016
  Purpose

The main objective of this project is to demonstrate the utility of a biomarker of efficacy for the biologics, adalimumab or vedolizumab, 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.


Condition Intervention
ULCERATIVE COLITIS
Drug: VEDOLIZUMAB
Drug: ADALIMUMAB

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT)

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Demonstrate the feasibility of ex vivo labeling of intestinal immune cells with a combination of two markers: vedolizumab-FITC and adalimumab-Alexa Fluor 647 [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: Week 22 ] [ Designated as safety issue: No ]
    -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

  • 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 [ Time Frame: week 22 ] [ Designated as safety issue: No ]
    - Number of fluorescent cells / Mayo clinic sub-score

  • 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 [ Time Frame: week 22 ] [ Designated as safety issue: No ]
    - Number of fluorescent cells / Geboes sub-score

  • 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 [ Time Frame: week 22 ] [ Designated as safety issue: No ]
    - Number of fluorescent cells / Mayo endoscopic sub-score,

  • 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 [ Time Frame: week 22 ] [ Designated as safety issue: No ]
    - Number of fluorescent cells / rectal bleeding score

  • Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of clinical response at w30 to adalimumab [ Time Frame: from week 0 to week 30 ] [ Designated as safety issue: No ]
    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

  • Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of endoscopic remission at w30 to adalimumab [ Time Frame: from week 0 to week 30 ] [ Designated as safety issue: No ]
    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,

  • Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of endoscopic remission at w30 to adalimumab [ Time Frame: from week 0 to week 30 ] [ Designated as safety issue: No ]
    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / Geboes sub-score

  • Evaluate the association between the Alexa Fluor 647-coupled adalimumab biomarker, and the rate of clinical remission at w30 to adalimumab [ Time Frame: from week 0 to week 30 ] [ Designated as safety issue: No ]
    Evolution of Number of fluorescent cells by Cellvizio® examination field for each of the antibodies between week 0 and week 22 / rectal bleeding score

  • Compare the number of positive immune cells FITC-coupled vedolizumab in the intestinal mucosa of patients with UC [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Average of Number of fluorescent cells FITC-coupled vedolizumab / patient

  • Compare the number of positive immune cells Alexa Fluor 647-coupled adalimumab in the intestinal mucosa of patients with UC [ Time Frame: week 0 ] [ Designated as safety issue: No ]
    Average of Number of fluorescent cells Alexa Fluor 647-coupled adalimumab/ patient


Estimated Enrollment: 25
Study Start Date: October 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VEDOLIZUMAB
perfusion of 300 mg
Drug: VEDOLIZUMAB
Injection at week 0 week 2 week 6 week 14 for all patients Injection at week 22 for responder patient only
Other Name: entyvio
Drug: ADALIMUMAB
For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28
Other Name: HUMIRA

Detailed Description:

Patients will be recruited before initiation of vedolizumab injections. The schedule for vedolizumab perfusions will be established corresponding with protocol follow-up visits (Week 0, W2, W6, W14, W22), and flexible sigmoidoscopy appointments will be booked (W0 and W22).

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

From W2 to week 22, nonresponder patients will discontinue vedolizumab injections. Nonresponder patients may be treated with 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).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02878083

Contacts
Contact: ARNAUD BOURREILLE, MD-PHD +33 2 40 08 31 52 arnaud.bourreille@chu-nantes.fr

Locations
France
Chu Angers Not yet recruiting
Angers, France
Contact: NINA DIB       nidib@chu-angers.fr   
Chd Vendee Not yet recruiting
La Roche Sur Yon, France
Contact: MORGANE AMIL       morgane.amil@chd-vendee.fr   
Chu Nantes Not yet recruiting
Nantes, France
Contact: ARNAUD BOURREILLE       arnaud.bourreille@chu-nantes.fr   
Chu Rennes Not yet recruiting
Rennes, France
Contact: GUILLAUME BOUGUEN       guillaume.bouguen@chu-rennes.fr   
Sponsors and Collaborators
Nantes University Hospital
Takeda
Mauna Kea Technologies
Institut national de la santé et de la recherche médicale unité 913 FRANCE
Institut national de la santé et de la recherche médicale unité1064 FRANCE
Investigators
Principal Investigator: ARNAUD BOURREILLE, MD-PHD CHU DE NANTES
  More Information

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02878083     History of Changes
Other Study ID Numbers: RC15_0457 
Study First Received: August 16, 2016
Last Updated: August 19, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
vedolizumab,
confocal endomicroscopy
biomarker
ULCERATIVE COLITIS

Additional relevant MeSH terms:
Vedolizumab
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 29, 2016