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Inflammatory Bowel DiseasesPEREMNCT04990258

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

An observational study of Inflammatory Bowel Diseases, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Inflammatory Bowel Diseases
What is being tested?
Subcutaneous infliximab CT-P13 Remsima®SC
Type of treatment
Injection or infusion
How many people
444 participants
Where
1 siteFrance
Study dates
6 Sep 2021to 30 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nicolas Mathieu

    Grenoble, 38000

Other trials in France

About this study

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.

Read the detailed 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
Being tested
Subcutaneous infliximab CT-P13 Remsima®SC
Keywords
IBD UC
Medical subject headings
Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subcutaneous infliximab CT-P13 Remsima®SCDrug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 12

  2. Efficacy of Subcutaneous infliximab treatment in clinical remission

    Steroid-free clinical remission 24 months after switching

    Measured: Month 24

  3. Safety of subcutaneous infliximab treatment

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

    Measured: Month 24

Secondary outcomes (10)

  1. Ratio efficacy of SC Infliximab in clinical remission

    Percentage of patients on steroid free clinical remission at month 24 after switch.

    • Steroid-free Clinical Remission (CR) is defined 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.
    • When HBI scoring will not be feasible (stoma, pouch), evaluation of clinical remission will be estimated by physician global assessment.
    • Patients having discontinued subcutaneous infliximab therapy whatever the reason during the 12 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 subcutaneous infliximab Remsima®SC during the whole study period

    Measured: Month 24

  2. Loss of response to infliximab SC treatment

    Percentage of patients who switch back to originator previous therapy IV infliximab at month 12 after switching from IV infliximab to SC infliximab Remsima®SC in IBD patient

    Measured: Month 12

  3. Efficacy of SC Infliximab treatment on patient quality of life

    Percentage of PRO2 response and remission at month 12

    Measured: Month 12

  4. Efficacy of SC Infliximab treatment in biological remission

    Percentage of biological remission rates (FC <250 μg/g, CRP <5 mg/L) at month 12

    Measured: Month 12

  5. Efficacy of SC Infliximab treatment in preventing relapse

    Percentage of clinical relapse free rates at month 12.

    Measured: Month 12

  6. Efficacy of SC Infliximab treatment in preventing loss of respone

    Percentage of loss of response rates at month 12

    Measured: Month 12

  7. Loss of clinical response

    Percentage of clinical response and remission at month 3

    Measured: Month 3

  8. Disease activity

    Mean change from baseline in

    • For Crohn Disease: HBI( Harvey Bradshaw Index):
    • For Ulcerative Colitis: PMS ( Partial 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 1 g of stool

    HBI score, PMS score, CRP and Calprotectin feacal will be combined to report the disease activity (this outcome is is expressed without units)

    Measured: Month 24

  9. Treatment adherence

    Proportion of patients with positive antibodies (IFX, ADA) comparing therapy with original and SC infliximab.

    Measured: Month 24

  10. Medication Possession Ratio (MPR)

    Adherence to biosimilar switch during the follow-up: MPR ratios.

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2021
  2. Study start6 Sep 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04990258
Sponsor's protocol ID
GT-2021-02
Acronym
PEREM
Status last verified
Jan 2024
First submitted
14 Jun 2021
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subcutaneous infliximab dosage after switch (time frame: Month 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04990258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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