Subcutaneous Infliximab After A Previous Intravenous Dose Optimization

NCT06113913 | Recruiting Phase 4

• 1 other identifier: BIRD2023001
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 15

Brief Summary

The goal of this clinical trial is to learn about the treatment with subcutaneous infliximab in patients with inflammatory bowel disease (IBD) that were previously treated with an optimized dose of intravenous infliximab. The main question it aims to answer is: \- Is switching to a weekly dose of subcutaneous infliximab (120 mg) associated with a better outcome compared to the standard fortnightly administration of 120 mg subcutaneous infliximab in patients who received an optimized intravenous dosing schedule? Participants will switch from intravenous infliximab to subcutaneous infliximab and will be randomized to the intervention arm (Subcutaneous infliximab weekly) or the interventional comparison arm (subcutaneous infliximab bi-weekly). Participants will follow daily clinical practice in the monitoring for clinical and biological remission. The participants that are willing to switch to subcutaneous infliximab will be compared to a group of participants not willing to switch. These participants will continue to be treated with their optimized intravenous dose of infliximab.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

remission; infliximab

Outcome Measures

Primary Outcomes (1)

• • The proportion of patients that maintain steroid-free clinical and biological remission by week 52 without treatment optimization after switch to SC infliximab (composite endpoint)

  week 52

Secondary Outcomes (15)

• • The proportion of patients that maintain steroid-free clinical and biological remission by week 52 with treatment optimization

  week 52

• • The proportion of patients that maintain steroid-free clinical and biological remission by week 52 (with or without treatment optimization)

  week 52

• • The proportion of patients that maintain steroid-free clinical and biological remission by week 8, by week 24 (without treatment optimization)

  week 8 and week 24

• • The proportion of patients that maintain steroid-free clinical remission by week 8, by week 24, by week 52 (without treatment optimization)

  week 8, week 24 and week 54

• • The proportion of patients that maintain steroid-free biological remission by week 8, by week 24, by week 52 (without treatment optimization)

  week 8, week 24 and week 52

Other Outcomes (5)

• The association of infliximab trough level and antibody level (if available) at screening to the maintenance of clinical and biological remission after switch to SC infliximab.

  Between week 0 and week 52

• The association of the IV dosing schedule to the maintenance of clinical and biological remission after switch to SC infliximab.

  Between week 0 and week 52

• The total cost of infliximab therapy

  Between week 0 and week 52

Study Arms (3)

Interventional (SC infliximab, weekly)

EXPERIMENTAL

Participants will switch from an optimized dose of intravenous infliximab to an optimized dose of subcutaneous infliximab. This means the participants will inject 120 mg subcutaneous infliximab every week.

Drug: Infliximab

Interventional comparator (SC infliximab, bi-weekly)

EXPERIMENTAL

Participants will switch from an optimized dose of intravenous infliximab to subcutaneous infliximab. This means the participants will inject 120 mg subcutaneous infliximab every other week.

Drug: Infliximab

Intravenous comparator (IV infliximab, optimized dosing schedule)

ACTIVE COMPARATOR

Participants not willing to switch will continue treatment with intravenous infliximab at the same dosing schedule as before.

Drug: Infliximab

Interventions

Infliximab DRUG

Weekly administration of subcutaneous infliximab.

Interventional (SC infliximab, weekly)

Eligibility Criteria

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

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any Screening procedures.
• Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical, endoscopic, histological, and/or radiological criteria
• Males and females ≥18 years old.
• Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks.
• Patients must be in biological remission at screening defined as a CRP \<10 mg/L and a fecal calprotectin \<250 µg/g.
• Patients receiving IV infliximab for at least 26 consecutive weeks.
• Patients receiving a stable IV infliximab dosing schedule for at least 20 weeks.
• Patients receiving an average IV infliximab dose per 8 weeks based on the two most recent IV administration of more than 8 mg/kg, but not more than 22 mg/kg
• Patients who speak and read fluently Dutch, French or English.

You may not qualify if:

• Male or female ≤ 18 years
• Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy
• Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device
• Patients previously treated with SC infliximab
• Patients with active perianal fistulizing disease
• Patients with microscopic colitis

Sponsors & Collaborators

• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW: lead
• Celltrion: collaborator

Study Sites (15)

AZ Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

RECRUITING

AZ Oostende

Ostend, West-Vlaanderen, Belgium

RECRUITING

Universitair ziekenhuis Antwerpen

Antwerp, Belgium

RECRUITING

Imeldaziekenhuis

Bonheiden, Belgium

RECRUITING

AZ Sint-Jan Brugge

Bruges, Belgium

NOT YET RECRUITING

Erasme

Brussels, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

AZ Sint-Lucas Gent

Ghent, Belgium

RECRUITING

Universitair ziekenhuis Gent

Ghent, Belgium

RECRUITING

Universitair ziekenhuis Leuven

Leuven, Belgium

RECRUITING

Heilig Hart ziekenhuis Lier

Lier, Belgium

RECRUITING

CHU Liège - Sart Tilman

Liège, Belgium

RECRUITING

VITAZ

Sint-Niklaas, Belgium

RECRUITING

AZ Vesalius

Tongeren, Belgium

RECRUITING

CHwapi

Tournai, Belgium

RECRUITING

Related Links

• BIRD website

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tom Holvoet, MD, PhD

  Department of Gastroenterology, VITAZ Sint-Niklaas

  PRINCIPAL INVESTIGATOR

• Annick Moens, MD, PhD

  Department of Gastroenterology Heilig Hartziekenhuis Lier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Arijs, Phd

CONTACT

+32499317005; ingrid.arijs@birdgroup.be

Jolien De Rechter

CONTACT

+32498748400; jolien.de.rechter@birdgroup.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: November 2, 2023
• Study Start: April 9, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (15)