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

Not Applicable

Recruiting

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.

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.

Recruitment & Eligibility

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

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Collection of clinical parameters, blood and stools samples	Biocollection	Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
Mean change from baseline in CRP	Week 48
infliximab through levels	Week 48
Clinical response defined as a decrease in CDAI ≥100 from the baseline CDAI score in patients with CD	Week 48
Percentage of patients who switch back to IV infliximab	Week 48	Percentage of patients who switch back to IV infliximab
Mean change from baseline in SCCAI score in patients with UC	Week 48
Mean change from baseline in fecal calprotectin	Week 48
clinical remission	Week 12	clinical response and remission
Mean change from baseline in CDAI score in patients with CD	Week 48
Development of anti-infliximab antibodies	Week 48

Locations (1): Saint Antoine Hospital Service de Gastroentérologie et Nutrition
🇫🇷
Paris, France