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 (PEREM)

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    400
  • sponsor
    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Updated on 4 October 2022
remission
methotrexate
infliximab
azathioprine
biosimilar
remicade

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.

Description

Number of patients: 400 patients in approximatively 40 sites in France Recrutment period: The trial duration for each patient will be 2 years Main Endpoint:The primary endpoint is to assess the rate of persistence of subcutaneous infliximab at month 12 after switching from IV infliximab to SC infliximab Remsima®SC.

Secondary Endpoint:

  • Percentage of patients on steroid free clinical remission at week 96 after switch. Steroid-free Clinical Remission (CR) is defined as a Harvey Bradshaw Index (HBI) score≤4 CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC. When HBI scoring will be infeasible (stoma, pouch), evaluation of clinical remission will be estimated by stoma emptying count and/or by the physician global assessment (Sturm 2019) Patients having discontinued subcutaneous infliximab Remsima®SC therapy whatever the reason during the 24 months of follow-up as well as patients referred to disease-related surgery and patients lost to follow-up before month 24 will be considered as failure to subcutaneous infliximab Remsima®SC therapy (intention to treat analysis) and will be classified in the group of patients having failed to maintain steroid free clinical remission under infliximab Remsima®SC during the whole study period.
  • Percentage of patient Reported Outcomes PRO2 rates at inclusion, months 3, 6, 12 and 24
  • Percentage of biological remission rates (FC <250 μg/g, CRP <5 mg/L) at inclusion, month 3, 6, 12 and 24.
  • Percentage of clinical relapse free rates at inclusion, month 3, 6, 12 and 24
  • Percentage of loss of response rates at inclusion, month 3, 6, 12 and 24
  • Percentage of clinical response and remission at inclusion, month 3, 6, 12 and 24
  • Mean change from baseline in HBI or PMS, and mean change from baseline in CRP and fecal calprotectin
  • Proportion of patients with positive antibodies (IFX, ANA) comparing therapy with intravenous or one of its biosimilars original and subcutaneous infliximab Remsima®SC
  • Measure adherence to subcutaneous infliximab Remsima® switch based on pharmacy data during the follow-up with Medication Possession Ratio (MPR ).
  • Twelve-month cumulative surgery rates
  • Hospitalization rate at month 24
  • Cumulative infection rate at month 24
  • Cumulative SC reactions at month 24
  • Discontinuation of subcutaneous infliximab therapy cumulative rates at month 24
  • Incidence of specific anti-drug antibodies detected during the study

Details
Condition Inflammatory Bowel Diseases
Treatment Subcutaneous infliximab CT-P13 Remsima®SC
Clinical Study IdentifierNCT04990258
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• 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
Azathioprine, 6-MP or methotrexate provided the dose has been stable for 4 weeks prior to inclusion (dose must remain stable for 10 weeks after switching)
Each patient is required to provide written informed consent to be included in the study

Exclusion Criteria

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
Treatment with any investigational agent in the past 30 days or five half-lives prior to the inclusion visit
Current CD abscess
Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
Female subjects with pregnancy or breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note