PRIME: IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05722353

Collaborator

(none)

120

Enrollment

Location

Arm

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CURRENT STATE OF KNOWLEDGE IN VIEW OF THE RESEARCH About the condition under investigation Inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis, are chronic diseases characterized by relapsing and remitting episodes.

About comparator strategies/procedures Infliximab in its Intravenous (IV) form was the first biotherapy to be approved to treat IBD. Biosimilars of intravenous (IV) infliximab have been shown to be non-inferior to the reference product in patients with IBD, to induce and maintain clinical response

Recently, the subcutaneous (SC) formulation of the infliximab biosimilar CT-P13 (CT-P13 SC) has been shown to be non-inferior on CT-P13 concentration at week 22 to the IV formulation of CT-P13 (CT-P13 IV). These results were based on 66 patients treated with CT-P13 SC, and larger studies are needed to better assess IBD disease course of patients treated with CT-P13 SC in real-life setting.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Diseases	Other: Biocollection	N/A

Detailed Description

The study assesses in real-life setting the IBD disease course of infliximab-naïve IBD patients treated with subcutaneous infliximab. This study will look at the clinical and biological outcomes of people who take subcutaneous infliximab.

The study will enroll approximately 120 participants with an indication for iv infliximab.

All participants will receive 1 intravenous infusion on Day 1 and Week 2, followed by 1 SC injection on Week 6 and then 1 SC injection every 2 weeks for up to Week 48.

Switch to subcutaneous infliximab (Remsima® SC) at week 6 will be proposed as part of standard of care.

This multi-center trial will be conducted in hospitals of Assistance Publique - Hôpitaux de Paris (AP-HP). The overall time to participate in this study is 48 weeks. Participants will make approximately 5 visits to the clinic.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

IBD Disease Course of Infliximab-naïve IBD Patients Treated With Subcutaneous Infliximab CT-P13 Remsima®

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2026

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Other: Collection of clinical parameters, blood and stools samples Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.	Other: Biocollection Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Arm

Intervention/Treatment

Other: Collection of clinical parameters, blood and stools samples

Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Other: Biocollection

Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Outcome Measures

Primary Outcome Measures

Steroids Steroid-free clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150 in patients with CD [week 48]
Steroids Steroid-free clinical remission defined as Simple clinical colitis activity index (SCCAI) < 3 in patients with UC [week 48]

Secondary Outcome Measures

Clinical response defined as a decrease in CDAI ≥100 from the baseline CDAI score in patients with CD [Week 48]
Clinical response defined as a decrease in SCCAI ≥ 3 from the baseline SCCAI score in patients with UC [Week 48]
Biological remission [Week 48]
Biological remission is based on CRP level < 5mg/dL
Percentage of patients who switch back to IV infliximab [Week 48]
Percentage of patients who switch back to IV infliximab
clinical relapse-free rates [Week 48]
Relapse will be based on physician global assessment
loss of response rates [Week 48]
loss of response rates at week 48
clinical remission [Week 12]
clinical response and remission
Mean change from baseline in CDAI score in patients with CD [Week 48]
Mean change from baseline in SCCAI score in patients with UC [Week 48]
Mean change from baseline in CRP [Week 48]
Mean change from baseline in fecal calprotectin [Week 48]
infliximab through levels [Week 48]
Development of anti-infliximab antibodies [Week 48]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of Crohn's disease or ulcerative colitis (confirmed by clinical evaluation and a combination of endoscopic, histological, radiological, and/or biochemical investigations according to European guidelines)
Starting infliximab as standard of care (originator or biosimilars)
with or without concomitant immunosuppressive agent and/or steroids use at infliximab initiation
Patients agreeing to participate