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

NCT05722353 | Active Not Recruiting

• 2 other identifiers: APHP2113432022-A01567-36
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Keywords

Inflammatory bowel disease; Crohn Disease; Colitis; Ulcerative; Infliximab

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• 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

• Percentage of patients who switch back to IV infliximab

  Week 48

• clinical relapse-free rates

  Week 48

Study Arms (1)

Collection of clinical parameters, blood and stools samples

OTHER

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

Other: Biocollection

Interventions

Biocollection OTHER

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

Collection of clinical parameters, blood and stools samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Antoine Hospital Service de Gastroentérologie et Nutrition

Paris, 75012, France

Location

Related Publications (4)

• 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.

  PMID: 16339095 BACKGROUND

• 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.

  PMID: 12047962 BACKGROUND

• 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.

  PMID: 30929895 BACKGROUND

• 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.

  PMID: 33676969 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis; Ulcer

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Julien Kirchgesner

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: February 10, 2023
• Study Start: February 13, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

FR (1)