Inflammatory Bowel Diseases
Conditions
Keywords
Inflammatory bowel disease, Crohn Disease, Colitis, Ulcerative, Infliximab
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.
Interventions
OTHERBiocollection
Collection of blood samples and feces specimen at inclusion visit; clinical and biological assessment at each visit.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Participation in another interventional study * No coverage by the French health insurance
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in fecal calprotectin | Week 48 | — |
| infliximab through levels | Week 48 | — |
| Development of anti-infliximab antibodies | 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 | — |
| 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 response defined as a decrease in CDAI ≥100 from the baseline CDAI score in patients with CD | Week 48 | — |
| Mean change from baseline in CRP | Week 48 | — |
Countries
France
Outcome results
None listed