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

Inflammatory Bowel Diseases Clinical Trial

— DOPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158517
• Other study ID #: GT-2021-04
• Status: Recruiting
• Start date: March 20, 2022
• Est. completion date: March 20, 2025

Study information

• Verified date: May 2023
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 20, 2025
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

Intervention

Drug:
• Subcutaneous vedolizumab
Patients will be switched from IV vedolizumab into subcutaneous vedolizumab

Locations

Country	Name	City	State
France	Thomas Chateau	Grenoble	Auvergne-Rhone-Alpes

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Takeda

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subcutaneous vedolizumab dosage after switch	To describe subcutaneous vedolizumab persistence after the switch from IV vedolizumab to SC vedolizumab at month 12	Month 12
Primary	Efficacy of subcutaneous vedolizumab treatment in clinical remission	Steroid-free clinical remission 12 months after switching	Month 12
Primary	Safety of subcutaneous vedolizumab treatment	Proportion of participants with treatment-related adverse events for a period of 12 months after swiching	Month 12
Secondary	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
Secondary	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
Secondary	Efficacy of SC vedolizumab treatment on patient quality of life	Percentage of PRO2 response and remission at month 12	Month 12
Secondary	Efficacy of SC vedolizumab treatment in biological remission	Percentage of biological remission rates (FC<250µg/g, CRP<5mg/L) at month 12	Month 12
Secondary	Efficacy of SC vedolizumab treatment in preventing relapse	Percentage of clinical relapse free rates at month 12	Month 12
Secondary	Efficacy of SC vedolizumab treatment in preventing loss of response	Percentage of loss of response rates at month 12	Month 12
Secondary	Loss of clinical response	Percentage of clinical response and remission at month 3	Month 3
Secondary	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
Secondary	Treatment adherence	Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with original and SC vedolizumab	Month 12
Secondary	Medication Possession Ratio (MPR)	Adherence to biosimilar switch during the follow-up : MPR ratios	Month 12