Study on Subcutaneous Infliximab for Patients with Ulcerative Colitis, Crohn’s Disease, or Unclassified Inflammatory Bowel Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called infliximab on patients with certain types of inflammatory bowel diseases, including Ulcerative Colitis, Crohn’s Disease, and Inflammatory Bowel Disease Unclassified. The study involves switching patients from an intravenous (IV) form of infliximab, which is administered directly into a vein, to a subcutaneous (SC) form, which is injected under the skin. The purpose of the study is to compare the outcomes of patients receiving subcutaneous infliximab every week with those receiving it every other week, after they have been stabilized on an optimized intravenous schedule.

Participants in the study will have previously been in a state of remission, meaning their disease symptoms were under control, without the use of steroids. The study will observe patients over a period of time to see if they can maintain this remission while using the subcutaneous form of infliximab. The trial will last up to 52 weeks, during which the health and experiences of the participants will be monitored to assess the effectiveness and safety of the subcutaneous treatment.

The study will also look at how many patients remain in remission without needing to adjust their treatment, as well as how many might need to switch back to the intravenous form of infliximab. Additionally, the trial will gather information on patients’ satisfaction with the subcutaneous treatment and any side effects they may experience. This research aims to provide valuable insights into the management of these chronic conditions and potentially offer a more convenient treatment option for patients.

1 joining the study

Upon joining the study, the patient must have a confirmed diagnosis of Crohn’s disease, ulcerative colitis, or inflammatory bowel disease type unclassified. The patient must be in clinical and biological remission without the use of steroids for at least eight weeks prior to the screening.

The patient must have been receiving intravenous (IV) infliximab for at least 26 consecutive weeks with a stable dosing schedule for at least 20 weeks.

2 initial assessment

The patient undergoes an initial assessment to confirm clinical and biological remission. This includes checking the rectal bleeding score, stool frequency score, abdominal pain score, and liquid stool frequency score.

Blood tests are conducted to ensure C-reactive protein (CRP) levels are below 10 mg/L and fecal calprotectin levels are below 250 µg/g.

3 switch to subcutaneous infliximab

The patient switches from intravenous infliximab to subcutaneous infliximab. The subcutaneous administration is done either weekly or every other week, depending on the regimen assigned.

The objective is to maintain clinical and biological remission without the need for treatment optimization.

4 monitoring and follow-up

The patient is monitored regularly to assess the maintenance of steroid-free clinical and biological remission. This includes evaluations at weeks 8, 24, and 52.

The patient’s experience and satisfaction with the switch to subcutaneous therapy are also assessed during these follow-up visits.

5 end of study evaluation

At the end of the study period, the patient’s overall health and remission status are evaluated. The primary endpoint is the proportion of patients maintaining remission by week 52 without treatment optimization.

Secondary endpoints include the proportion of patients maintaining remission with or without treatment optimization and the time to clinical relapse or treatment discontinuation.

Who Can Join the Study?

Patients must have a previously documented diagnosis of Crohn’s disease (CD), Ulcerative colitis (UC), or Inflammatory bowel disease type unclassified (IBDU). This diagnosis should be confirmed by medical tests such as clinical exams, endoscopy (a procedure to look inside the digestive tract), histology (study of tissues), or radiology (imaging tests).
Both males and females who are 18 years old or older can participate.
Patients must be in steroid-free clinical remission at the time of screening. This means they should not have used steroids for the past eight weeks and should have specific scores for symptoms like rectal bleeding and stool frequency for UC/IBDU, or abdominal pain and liquid stool frequency for CD.
Patients must be in biological remission at screening, which means having a C-reactive protein (CRP) level of less than 10 mg/L and a fecal calprotectin level of less than 250 µg/g. These are tests that help measure inflammation in the body.
Patients should have been receiving intravenous (IV) infliximab for at least 26 consecutive weeks. Infliximab is a medication used to treat these conditions.
Patients should have been on a stable IV dosing schedule for at least 20 weeks.
Patients should have received an average IV infliximab dose every eight weeks, based on the two most recent administrations, of more than 8 mg/kg but not more than 22 mg/kg.
Patients must be able to speak and read fluently in Dutch, French, or English.
Patients must be able to voluntarily give their written informed consent, which means they agree to participate in the study after understanding all the details.

Who Cannot Join the Study?

Patients who are not in clinical remission. This means their symptoms are not under control.
Patients who are not in biological remission. This means their lab tests do not show improvement.
Patients who have not been on an optimized intravenous schedule before switching to the new treatment. This means they haven’t been receiving the previous treatment in the best possible way.
Patients who are part of a vulnerable population. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Az Maria Middelares Gent	Gent	Belgium
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Vitaz	Sint-Niklaas	Belgium
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
centre Hospitalier de Wallonie Picarde	Tournai	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Ziekenhuis Oost Limburg	Genk	Belgium
Hwqwkxuqxdgquirfiouu Lhld	Lier	Belgium
Ikvrbu	Bonheiden	Belgium
Ap Vdtxumvv	Tongeren	Belgium
Odkpzpepcpvtjlzrqyvzifepde	Aalst	Belgium
Uuzdktwgip Oi Artncko	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Infliximab

Infliximab: In this clinical trial, infliximab is being used in a subcutaneous form. Infliximab is a medication that helps reduce inflammation in the body. It is often used to treat conditions like rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. The trial is comparing the effects of administering infliximab under the skin every week versus every other week. The goal is to see which schedule is more effective for patients who were already in remission with a previous intravenous treatment.

Investigated diseases:

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of flare-ups and remissions. Over time, the inflammation can cause ulcers to form on the colon lining, which may lead to complications if not managed properly.

Inflammatory Bowel Disease Type Unclassified – Inflammatory bowel disease type unclassified (IBDU) is a condition where the symptoms and inflammation in the digestive tract do not clearly fit the criteria for either Crohn’s disease or ulcerative colitis. Patients with IBDU experience symptoms such as abdominal pain, diarrhea, and fatigue. The disease progression can vary, with some individuals experiencing mild symptoms and others having more severe episodes. The inflammation can affect different parts of the digestive tract, making it challenging to categorize.

Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is characterized by patchy areas of inflammation, which can penetrate deep into the layers of the bowel tissue. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The disease can progress with periods of remission and flare-ups, potentially leading to complications such as strictures or fistulas.

Trial ID:

2023-508166-15-00

Protocol code:

BIRD2023001

NCT ID:

NCT06113913

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Subcutaneous Infliximab for Patients with Ulcerative Colitis, Crohn’s Disease, or Unclassified Inflammatory Bowel Disease

What is this study about?

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Who Cannot Join the Study?