Long-Term Study of Ustekinumab for Patients with Crohn’s Disease Who Previously Lost Response to Treatment

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What is this study about?

This clinical trial is focused on studying Crohn’s disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The treatment being tested in this study is called ustekinumab, which is given as a 90 mg solution for injection in a pre-filled syringe. Ustekinumab is a type of medication known as a biologic, which means it is made from living organisms or their cells and is used to target specific parts of the immune system.

The purpose of this study is to monitor the long-term effectiveness and safety of ustekinumab in patients with Crohn’s disease who have previously participated in a related study. In this trial, patients will receive ustekinumab injections every four weeks. The study will observe how well patients respond to this treatment over time, particularly those who had a reduced response to a previous dosing schedule of every eight weeks.

Participants in the study will be monitored for a period of time to assess their response to the treatment, including whether they achieve remission, which means their symptoms are reduced or disappear. The study will also track any side effects or adverse events that may occur. The goal is to determine if the adjusted dosing schedule of ustekinumab can help maintain symptom control and improve the quality of life for patients with Crohn’s disease.

1 joining the study

Participation begins after completing the previous REScUE study. Eligibility requires reaching the end of the REScUE study at week 48.

Participants must be able to understand and sign an informed consent form and adhere to the study visit schedule and other protocol requirements.

2 medication administration

The medication used is STELARA 90 mg, which is a solution for injection in a pre-filled syringe.

The medication is administered through a subcutaneous injection.

The dosage is 90 mg every four weeks (Q4w).

3 monitoring and assessments

The study aims to assess the long-term clinical efficacy of the ustekinumab 90 mg SC Q4w regimen in patients with Crohn’s disease.

Participants will be monitored for the proportion of patients in steroid-free clinical remission at both week 56 and week 112.

Secondary assessments include the incidence and severity of adverse events, time to Crohn’s disease worsening, and various remission statuses at specified weeks.

4 study duration

The estimated end date of the study is December 31, 2026.

The study began recruiting participants on September 10, 2021.

Who Can Join the Study?

Must have been part of the REScUE study and completed it at week 48.
Females of childbearing age must use adequate contraception. This means using methods like birth control pills, patches, injections, an intra-uterine device (IUD), sterilization, or barrier methods like condoms. Males must use sterilization or barrier methods if their female partner can have children.
Must be able to understand and sign a form that explains the study and gives their permission to participate.
Must be able to follow the schedule for study visits and meet other study requirements.

Who Cannot Join the Study?

Patients who have not previously participated in the REScUE study.
Patients who have not experienced a secondary loss of response to the ustekinumab 90mg SC Q8w regimen. This means the treatment stopped working as well as it did before.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they 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 Turnhout	Turnhout	Belgium
AZ Sint-Lucas & Volkskliniek	Gent	Belgium
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Sint-Lucas General Hospital	Brugge	Belgium
Gasthuiszusters Antwerpen	Antwerp	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Cynaukxpl Uaxtoaeloborko Suwpiieyi	Woluwe-Saint-Lambert	Belgium
Ixspiv	Bonheiden	Belgium
Urxpjsnhdy Oq Ahkebzg	Edegem	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	10.09.2021

Trial locations

Investigated drugs:

Ustekinumab

Ustekinumab: This medication is used to treat Crohn’s disease, a condition that causes inflammation in the digestive tract. In this trial, patients who previously did not respond well to a lower frequency of this medication are being given a higher frequency to see if it improves their symptoms over the long term.

Crohn’s disease – Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can progress unpredictably, with some people experiencing frequent symptoms and others having long periods without issues. The exact cause of Crohn’s disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.

Trial ID:

2024-514326-23-00

Protocol code:

BIRD2020001

NCT ID:

NCT05299931

Trial Phase:

Human Pharmacology (Phase I) – Other

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Long-Term Study of Ustekinumab for Patients with Crohn’s Disease Who Previously Lost Response to Treatment

What is this study about?

Who Can Join the Study?

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