A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC

NCT04990258 | Unknown

• 1 other identifier: GT-2021-02
• Study Type: observational
• Target: 444
• Locations: 1 country
• Sites: 1

Brief Summary

Descriptive: A 24-month multicentre, observational, prospective cohort study. Population: IBD Patients under stable clinical and biological remission Study treatments: Patients who will be proposed to switch, or who have just switched, from the intravenous originator Remicade® or one of its biosimilars to the subcutaneous infliximab Remsima®SC as part of routine care. All consecutive 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 PEREM study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from IV infliximab to subcutaneous infliximab Remsima®SC.

Conditions

Inflammatory Bowel Diseases

Keywords

IBD UC

Outcome Measures

Primary Outcomes (3)

• Subcutaneous infliximab dosage after switch

  To describe subcutaneous infliximab persistence after the switch from IV infliximab originator Remicade® or one of its biosimilars to SC infliximab (Remsima®SC) at month 12.

  Month 12

• Efficacy of Subcutaneous infliximab treatment in clinical remission

  Steroid-free clinical remission 24 months after switching

  Month 24

• Safety of subcutaneous infliximab treatment

  Proportion of participants with treatment-related adverse events for a period of 24 months after switching

  Month 24

Secondary Outcomes (10)

• Ratio efficacy of SC Infliximab in clinical remission

  Month 24

• Loss of response to infliximab SC treatment

  Month 12

• Efficacy of SC Infliximab treatment on patient quality of life

  Month 12

• Efficacy of SC Infliximab treatment in biological remission

  Month 12

• Efficacy of SC Infliximab treatment in preventing relapse

  Month 12

Interventions

Subcutaneous infliximab CT-P13 Remsima®SC DRUG

Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.

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 ans, CD patients (HBI ≤4) or UC patients (PMS ≤2) with established diagnosis \> 6 months treated with Infliximab IV, agreeing to switch from IV to SC formulation or who have just switched to subcutaneous infliximab Remsima®SC 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.
• Patient affiliated to the health insurance system.
• Documented diagnosis of CD or UC established based on standard clinical, endoscopic, and 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 6 months.
• Currently treated with IV infliximab: originator or biosimilars.
• Patients agreeing to switch from IV to SC formulation or who have already switched since maximum 3 months.
• 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.
• Each patient is required to provide written informed consent to be included in the study.

You may not qualify if:

• Current use of vedolizumab or ustekinumab
• Current use of JAK inhibitors or S1P modulators
• Current use of steroids or within the last three months for IBD
• Current CD abscess
• 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
• Celltrion: collaborator

Study Sites (1)

Nicolas Mathieu

Grenoble, 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: June 14, 2021
• First Posted: August 4, 2021
• Study Start: September 6, 2021
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

FR (1)