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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Other: Biocollection


Participation Criteria
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Eligibility Criteria
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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: Patients not eligible to infliximab according to standard of care screening Previous exposure to infliximab: originator or biosimilars Previous or current exposure to vedolizumab, ustekinumab, or tofacitinib Participation in another interventional study No coverage by the French health insurance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Collection of clinical parameters, blood and stools samples<br>Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit. | Other: Biocollection<br>* Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Biological remission is based on CRP level < 5mg/dL | Week 48 | 
| Percentage of patients who switch back to IV infliximab | Percentage of patients who switch back to IV infliximab | Week 48 | 
| clinical relapse-free rates | Relapse will be based on physician global assessment | Week 48 | 
| loss of response rates | loss of response rates at week 48 | Week 48 | 
| clinical remission | clinical response and remission | Week 12 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory bowel disease, Crohn Disease, Colitis, Ulcerative, Infliximab