Study on Managing Moderate Postoperative Recurrence in Crohn’s Disease with Infliximab for Patients After Ileocolonic Surgery

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What is this study about?

This clinical trial focuses on the management of moderate postoperative recurrence in Crohn’s disease. Crohn’s disease is a chronic inflammatory condition that affects the digestive tract. The study aims to evaluate the effectiveness of a treatment strategy called therapeutic escalation in patients who have experienced a recurrence of Crohn’s disease after surgery. The treatment being studied involves the use of a medication called infliximab, which is available in two forms: a 120 mg solution for injection in a pre-filled pen, known as Remsima, and a 100 mg powder for concentrate for solution for infusion, also known as Remsima. Infliximab is a type of protein that helps reduce inflammation in the body.

The purpose of the study is to determine how well patients respond to the treatment over a period of 12 months. Participants in the study will be divided into two groups. One group will receive the therapeutic escalation treatment with infliximab, while the other group will continue with their current treatment plan. The study will monitor the participants’ health and the recurrence of Crohn’s disease symptoms through regular check-ups and assessments. The goal is to see if the therapeutic escalation approach can help prevent further recurrence of the disease after surgery.

Throughout the study, participants will receive either the infliximab treatment or a placebo, and their progress will be closely monitored by healthcare professionals. The study will last for a total of 12 months, during which time the effectiveness of the treatment will be evaluated based on specific criteria. The results of this study may provide valuable insights into the management of Crohn’s disease and help improve treatment options for patients experiencing postoperative recurrence.

1 joining the study

Eligibility is confirmed based on age (18-75 years) and a diagnosis of Crohn’s disease.

An intestinal resection with ileocolonic anastomosis must have been performed within the last 6-12 months.

A postoperative endoscopy is conducted between 6 and 12 months after surgery to assess the condition of the neoterminal ileum.

2 initial assessment

The endoscopic evaluation classifies the postoperative recurrence as i2 according to the Rutgeerts score.

This classification is validated by a blinded central reading.

3 randomization

Participants are randomly assigned to either the therapy escalation group or the status quo group.

4 treatment administration

In the therapy escalation group, infliximab is administered.

The medication is provided as Remsima 120 mg solution for injection using a pre-filled pen for subcutaneous administration.

Alternatively, Remsima 100 mg powder is used to prepare a solution for infusion, administered intravenously.

5 monitoring and follow-up

Participants are monitored for 12 months to evaluate the treatment’s effectiveness.

The primary goal is to achieve a modified Rutgeerts score of i0-i1 at 12 months.

Secondary outcomes include various health assessments and quality of life evaluations.

6 final assessment

At the end of the 12-month period, a final evaluation is conducted to determine the success of the treatment.

The results are compared to the initial assessments to measure improvement or progression.

Who Can Join the Study?

  • Must be between 18 and 75 years old.
  • Must have a diagnosis of Crohn’s disease based on standard criteria.
  • Must have had a surgery called intestinal resection with ileocolonic anastomosis to remove all Crohn’s disease-related inflammation within the last 6 to 12 months. This surgery connects two parts of the intestine. If the surgery was done in two stages, the endoscopy must be done 6 to 12 months after the bowel function is restored.
  • Must have had a postoperative endoscopy (a procedure to look inside the intestines) done between 6 and 12 months, with a 2-month flexibility, after the surgery. This endoscopy should reach the new end of the small intestine.
  • Must have a postoperative endoscopic recurrence classified as i2 according to the Rutgeerts score (a system to evaluate Crohn’s disease after surgery) at 6 to 12 months, confirmed by an independent review.

Who Cannot Join the Study?

  • Patients who have not had an ileocolonic anastomosis. This is a surgery where a part of the intestine is removed and the remaining ends are joined together.
  • Patients who do not have Crohn’s disease.
  • Patients who have not experienced an endoscopic postoperative recurrence. This means that after surgery, the disease has not returned as seen through a special camera used to look inside the body.
  • 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
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Intercommunal Creteil Creteil France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
CHU Grenoble Alpes La Tronche France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Algemeen Ziekenhuis Delta Roeselare Belgium
Hospital Universitario Rio Hortega Valladolid Spain
AZ Sint-Lucas & Volkskliniek Gent Belgium
Vitaz Sint-Niklaas Belgium
Algemeen Ziekenhuis Damiaan Oostende Ostend Belgium
centre Hospitalier de Wallonie Picarde Tournai Belgium
Centre Hospitalier D Avignon Avignon France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Universitaire De Montpellier Montpellier France
Jessa Ziekenhuis Hasselt Belgium
Centre Hospitalier De La Cote Basque Bayonne France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Centre Medico Chirurgical Ambroise Pare Hartmann Neuilly-Sur-Seine France
Centre Hospitalier Universitaire De Rennes Rennes France
Ziekenhuis Oost Limburg Genk Belgium
Vrije Universiteit Brussel Jette Belgium
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Cfjvla Hmektetqkpx Uabscuipxzhot Rkfiy Reims France
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Ifcguv Bonheiden Belgium
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Avafnbqgug Pcovzlcb Hakgndnf Dg Mjekuzgtp Marseille France
Bnmmlwhj Uwkibefspq Hbyegzok Cwhqwu Besançon France
Hiwyrxjz Uihgqrxtaospv Hqjzqlry Tvwty y Puaekj Ipdufshk Cinmky dxugmqsimczmiwzec (vqcx Badalona Spain
Irjbioqm dg Cuygzxfcnfve Hdxszlmbvjo Ulnotqzplmyax dg Sdhdb Exzpnrv (hjynygb Saint Priest En Jarez France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.12.2021
France France
Not recruiting
01.12.2021
Spain Spain
Not recruiting
01.12.2021

Trial locations

Investigated drugs:

Adalimumab is a medication used to reduce inflammation in the body. It is often prescribed for patients with Crohn’s disease to help manage symptoms and prevent flare-ups. In this trial, it is being used to see if it can help prevent the recurrence of symptoms after surgery.

Azathioprine is an immunosuppressive medication that helps to lower the body’s immune response. It is used in Crohn’s disease to maintain remission and prevent the disease from coming back after surgery. The trial is testing its effectiveness in preventing postoperative recurrence.

Ustekinumab is a medication that targets specific proteins in the immune system to reduce inflammation. It is used in Crohn’s disease to help control symptoms and maintain remission. This trial is evaluating its role in preventing the return of symptoms after surgery.

Investigated diseases:

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 lead to complications such as strictures, fistulas, and malnutrition. The disease can affect any part of the digestive tract from the mouth to the anus, and its exact cause is unknown, though it involves an abnormal immune response. Over time, the inflammation can cause damage to the intestinal walls, leading to further complications.

Trial ID:
2023-508242-18-00
Protocol code:
GETAID-2021-01
NCT ID:
NCT05072782
Trial Phase:
Therapeutic confirmatory (Phase III)

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