VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER) (DOPER)

VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study

Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.

Objectives : The primary objective of DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Subcutaneous vedolizumab

Detailed Description

Number of patients : 400 patients in approximatively 31 sites in France. Recrutment period : The trial duration for each patient will be 1 year main. Endpoint : The primary endpoint is to assess the rate of persistence of SC vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab.

Secondary Endpoint :

• Percentage of clinical remission at months 3 and 12, defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients
• Percentage of steroid free clinical remission at month 12
• Percentage of biological remission rates (defined as fecal calprotectin <250 μg/g and C-Reactive-Protein (CRP) <5 mg/L) at month 12
• Percentage of Patient-Reported Outcome 2 (PRO-2, defined as stool frequency and rectal bleeding for UC and stool frequency and abdominal pain for CD) response and remission at month 12
• Percentage of clinical relapse free rates at month 12
• Percentage of loss of response rates at month 12
• Mean change from baseline in PMS or HBI, CRP and fecal calprotectin compared to month 12
• Percentage of patients who switch back to previous IV vedolizumab therapy at month 12after switching from IV vedolizumab to SC vedolizumab
• Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with IV and SC vedolizumab
• Persistence of SC vedolizumab at month 12 in patients previously treated by IV vedolizumab every 4 weeks, compared to patients treated by IV vedolizumab every 8 weeks
• Twelve-month cumulative surgery rates
• Hospitalization rate at month 12
• Cumulative infection rate at month 12
• Cumulative injection reactions at month 12
• Cumulative adverse events (AEs) rate at month 12
• Comparison between incidence of specific anti-drug antibodies and incidence of AEs

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhone-Alpes
    • Grenoble, Auvergne-Rhone-Alpes, France, 38000
      • Recruiting
      • Thomas Chateau
      • Contact: Thomas Chateau; Phone Number: +33 476766702; Email: tchateau@chu-grenoble.fr
      • Principal Investigator: Nicolas Mathieu, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Age ≥ 18 years old, CD patients (HBI ≤ 4) or UC patients (PMS ≤ 2) with established diagnosis > 6 months treated with vedolizumab IV, agreeing to switch from IV to SC formulation or who have just switched to subcutaneous vedolizumab as part of routine care

Description

Inclusion Criteria:

• Male or female subjects who are more than 18 years of age, on the day of signing informed consent
• Documented diagnosis of IBD, established on the basis of standard clinical, endoscopic and/or histological criteria.
• CD or UC remission defined per clinical assessment as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) < 2 with each sub-score of 1 or less for UC and/or according to ECCO classification within previous 3 months
• Currently treated with IV vedolizumab
• Patients agreeing to switch from IV to SC formulation

• Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks):

  • Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching
  • Azathioprine, 6-Mercaptopurine or methotrexate provided the dose has been stable for 4 weeks prior to inclusion • Each patient is required to provide written informed consent in order to be included in the study

Exclusion Criteria:

• Current use of adalimumab, infliximab, golimumab or ustekinumab
• Current use of JAK inhibitors or S1P modulators
• Current use of steroids or within the last three months for IBD
• Treatment with any investigational agent in the past 30 days or five half-lives prior to the screening visit (whichever is longer)
• Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
• Female subjects with pregnancy or breastfeeding

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcutaneous vedolizumab dosage after switch	To describe subcutaneous vedolizumab persistence after the switch from IV vedolizumab to SC vedolizumab at month 12	Month 12
Efficacy of subcutaneous vedolizumab treatment in clinical remission	Steroid-free clinical remission 12 months after switching	Month 12
Safety of subcutaneous vedolizumab treatment	Proportion of participants with treatment-related adverse events for a period of 12 months after swiching	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio efficacy of SC vedolizumab in clinical remission	Percentage of patients on steroid free clinical remission at month 12 after switch : Steroid-free Clinical remission is defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients	Month 12
Loss of response to vedolizumab SC treatment	Percentage of patients who switch back to originator previous therapy IV vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab in IBD patient	Month 12
Efficacy of SC vedolizumab treatment on patient quality of life	Percentage of PRO2 response and remission at month 12	Month 12
Efficacy of SC vedolizumab treatment in biological remission	Percentage of biological remission rates (FC<250μg/g, CRP<5mg/L) at month 12	Month 12
Efficacy of SC vedolizumab treatment in preventing relapse	Percentage of clinical relapse free rates at month 12	Month 12
Efficacy of SC vedolizumab treatment in preventing loss of response	Percentage of loss of response rates at month 12	Month 12
Loss of clinical response	Percentage of clinical response and remission at month 3	Month 3
Disease activity	Mean change from baseline in : For Crohn Disease : HBI (Harvey Bradshow Index); For Ulcerative Colitis : PMS (Partiel Mayo Score); Biological criteria : CRP (mg/L) : Remission < 5 mg CRP in 1 litre of blood and fecal calprotectin (μg/g) : remission < 250 μg of fecal calprotectin in 1g of stool HBI score, PMS score, CRP ad calprotectin fecal will be combined to report the disease activity (this outcome is expressed without units)	Moth 12
Treatment adherence	Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with original and SC vedolizumab	Month 12
Medication Possession Ratio (MPR)	Adherence to biosimilar switch during the follow-up : MPR ratios	Month 12

Collaborators and Investigators

• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Collaborators: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Estimated): March 20, 2024
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: IBD UC
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: GT-2021-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No