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Study on Stopping Infliximab and Adalimumab Treatment in Patients with Crohn's Disease and Ulcerative Colitis in Remission

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients with Ulcerative Colitis and Crohn's Disease, which are types of inflammatory bowel diseases. The study is examining the effects of stopping treatment with medications known as anti-TNF drugs, specifically Infliximab and Adalimumab. These medications are used to help keep the diseases in remission, meaning the symptoms are reduced or not present.

The purpose of the study is to find out which patients can safely stop taking these medications while remaining in remission and which patients need to continue treatment. Participants in the study will either continue their current treatment or stop taking the medication. Some participants may receive a placebo. The study will monitor patients over a period of time to see if their symptoms return and to identify any factors that might predict a relapse.

Throughout the study, various health markers will be checked, such as endoscopic scores, which involve using a camera to look inside the digestive tract, and levels of fecal calprotectin, a substance found in stool that can indicate inflammation. The study will also look at the presence of anti-drug antibodies, which are proteins that the body might produce in response to the medication, and the balance of gut bacteria, known as microbiota. The goal is to better understand how to manage these diseases and improve treatment strategies for patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing the diagnosis of ulcerative colitis or Crohn's disease and ensuring the patient has been on infliximab or adalimumab treatment for more than 12 months.
The assessment also checks recent treatment consistency, with the last three doses being at the same dose and interval. For those on biosimilar-infliximab, at least three doses must have been received under the same conditions.
Step 2
Treatment discontinuation
Patients in remission will discontinue their maintenance anti-TNF treatment. This involves stopping medications such as Remicade, Remsima, Inflectra, or Humira.
The primary goal is to observe if patients can maintain remission without ongoing medication.
Step 3
Monitoring period
Patients are monitored for a period of 12 to 24 months after discontinuation of treatment. This involves regular check-ups to assess health status and detect any signs of relapse.
Monitoring includes evaluating symptoms, conducting endoscopic examinations, and measuring fecal calprotectin levels, which help in assessing inflammation in the digestive tract.
Step 4
Relapse assessment
If symptoms suggest a relapse, further assessments are conducted. This includes symptomatic scoring and endoscopic evaluations to confirm the relapse.
The study aims to identify factors that correlate with relapse, such as biological markers and trough concentrations of infliximab and adalimumab.
Step 5
Data analysis
Throughout the study, data is collected and analyzed to identify patterns and markers that may predict successful discontinuation of treatment or the likelihood of relapse.
The analysis includes examining endoscopic scores, fecal calprotectin levels, and the presence of anti-drug antibodies, among other factors.

Who can join the trial?

15 criteria

For patients with ulcerative colitis:
Must have a diagnosis of ulcerative colitis.
Age between 18 and 80 years.
Can be male or female.
Must have been on IFX or ADA treatment for more than 12 months, with the last 3 doses at the same dose and interval. If using a biosimilar-infliximab, must have received at least 3 doses at the same dose and interval.
SCCAI score of 3 or less. This is a score that measures the severity of symptoms.
Endoscopic Baron score of 0-1. This score checks the level of inflammation in the colon, specifically in the rectum or sigmoid colon. At least 40 cm of the colon should be examined.
For patients with Crohn's disease:
Must have a diagnosis of Crohn's disease.
Age between 18 and 80 years.
Can be male or female.
Must have been on IFX or ADA treatment for more than 12 months, with the last 3 doses at the same dose and interval. If using a biosimilar-infliximab, must have received at least 3 doses at the same dose and interval.
Simplified HBI score of 4 or less. This is a score that measures the severity of symptoms, excluding abdominal palpation.
Simplified Endoscopic Score for CD (SES-CD) of 4 or less, with no ulcers larger than 5 mm, except for possible anastomotic ulcers (small ulcers are allowed).
F-calprotectin level less than 200 mg/kg (PhiCal) or less than 350 mg/kg (Buhlmann). This is a test that measures inflammation in the intestines.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Ulcerative colitis or Crohn's disease cannot participate. These are conditions that cause inflammation in the digestive tract.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study based on certain characteristics.
Patients who are not able to give informed consent or are considered part of a vulnerable population may not be eligible. Vulnerable populations include groups like children or those unable to make decisions for themselves.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Karolinska University Hospital
Solna, Sweden
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Region Oestergoetland
Linkoping, Sweden
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Region Skane Skanes Universitetssjukhus
Lund, Sweden

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Investigated drugs

Anti-TNF Treatment is a type of medication used to reduce inflammation in patients with Crohn's disease and ulcerative colitis. It works by blocking a protein called tumor necrosis factor (TNF), which is involved in causing inflammation in the body. In this clinical trial, the role of anti-TNF treatment is to maintain remission in patients, and the study aims to determine which patients can safely stop this treatment while remaining in remission.

What is already known about the treatment

Infliximab – Infliximab is administered through intravenous infusion, typically in a clinical setting. It is currently well-established in medical literature as a treatment for inflammatory bowel diseases, such as ulcerative colitis and Crohn's disease. The main therapeutic indication for infliximab is to reduce inflammation and maintain remission in these conditions. At the molecular level, infliximab works by blocking tumor necrosis factor-alpha (TNF-alpha), a substance in the body that causes inflammation. It is classified as a monoclonal antibody and is part of the biologic drug category.

Investigated diseases

Ulcerative Colitis
This 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 remission. Over time, the inflammation can cause ulcers to form on the colon lining. The severity and extent of the inflammation can vary, affecting either a small segment or the entire colon. The exact cause is unknown, but it is believed to involve an abnormal immune response.
Crohn's Disease
This is a chronic inflammatory bowel disease 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 wall. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The disease can progress with alternating periods of flare-ups and remission. Over time, it may lead to complications such as strictures, fistulas, and malnutrition. The exact cause is not fully understood, but it is thought to involve a combination of genetic, environmental, and immune factors.