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

Inflammatory Bowel Diseases Clinical Trial

— PRIME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722353
• Other study ID #: APHP211343
• Secondary ID: 2022-A01567-36
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Julien Kirchgesner
• Phone: +33 1 49 28 31 72
• Email: julien.kirchgesner[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Disease Progression
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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

Locations

Country	Name	City	State
France	Saint Antoine Hospital Service de Gastroentérologie et Nutrition	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (4)

Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4. — View Citation

Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516. Erratum In: N Engl J Med. 2006 May 18;354(20):2200. — View Citation

Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5. — View Citation

Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Steroids Steroid-free clinical remission defined as Crohn's Disease Activity Index (CDAI) < 150 in patients with CD		week 48
Primary	Steroids Steroid-free clinical remission defined as Simple clinical colitis activity index (SCCAI) < 3 in patients with UC		week 48
Secondary	Clinical response defined as a decrease in CDAI =100 from the baseline CDAI score in patients with CD		Week 48
Secondary	Clinical response defined as a decrease in SCCAI = 3 from the baseline SCCAI score in patients with UC		Week 48
Secondary	Biological remission	Biological remission is based on CRP level < 5mg/dL	Week 48
Secondary	Percentage of patients who switch back to IV infliximab	Percentage of patients who switch back to IV infliximab	Week 48
Secondary	clinical relapse-free rates	Relapse will be based on physician global assessment	Week 48
Secondary	loss of response rates	loss of response rates at week 48	Week 48
Secondary	clinical remission	clinical response and remission	Week 12
Secondary	Mean change from baseline in CDAI score in patients with CD		Week 48
Secondary	Mean change from baseline in SCCAI score in patients with UC		Week 48
Secondary	Mean change from baseline in CRP		Week 48
Secondary	Mean change from baseline in fecal calprotectin		Week 48
Secondary	infliximab through levels		Week 48
Secondary	Development of anti-infliximab antibodies		Week 48