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

NCT05158517 | Active Not Recruiting

• 1 other identifier: GT-2021-04
• Study Type: observational
• Target: 349
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD UC

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Ratio efficacy of SC vedolizumab in clinical remission

  Month 12

• Loss of response to vedolizumab SC treatment

  Month 12

• Efficacy of SC vedolizumab treatment on patient quality of life

  Month 12

• Efficacy of SC vedolizumab treatment in biological remission

  Month 12

• Efficacy of SC vedolizumab treatment in preventing relapse

  Month 12

Interventions

Subcutaneous vedolizumab DRUG

Patients will be switched from IV vedolizumab into subcutaneous vedolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives: lead
• Takeda: collaborator

Study Sites (1)

Thomas Chateau

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: March 20, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 20, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

FR (1)