Study of adalimumab and infliximab dose adjustment guided by fecal calprotectin monitoring in adolescents and young adults with Crohn’s disease or ulcerative colitis

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What is this study about?

This study focuses on patients with Inflammatory Bowel Disease (IBD), specifically Crohn’s disease and Ulcerative colitis. These are chronic conditions that cause inflammation in different parts of the digestive system. The study examines two medications: adalimumab and infliximab, which belong to a group of drugs called anti-TNF medications that help reduce inflammation in the body.

The purpose of this research is to determine if adjusting the timing between doses of these medications can be done safely while maintaining the disease under control. The study monitors inflammation levels using a test called fecal calprotectin, which measures inflammation markers in stool samples. Participants will receive their usual medication (infliximab through an intravenous infusion or adalimumab through an injection under the skin), but some will have their dosing schedule adjusted.

During the study, which lasts 48 weeks, participants will have their inflammation levels regularly monitored through stool tests. The study will track how well the adjusted medication schedule works in keeping the disease under control and will also monitor any side effects, particularly focusing on skin conditions and respiratory infections that might occur during the treatment period.

1 Initial treatment phase

You will continue your current treatment with either infliximab (given through intravenous infusion every 8 weeks) or adalimumab (given through subcutaneous injection every 2 weeks)

Your current dosing schedule will be maintained while monitoring your condition

2 Regular monitoring

Your condition will be monitored through fecal calprotectin tests (a stool test that measures inflammation levels)

For Crohn’s disease, the target level is below 250 μg/g

For ulcerative colitis, the target level is below 150 μg/g

3 Treatment adjustment phase

Based on your test results, your medication schedule may be adjusted

Your symptoms and overall health will continue to be monitored throughout the 48-week study period

4 Health monitoring

You will be monitored for any side effects, particularly:

Respiratory infections

Skin-related changes (such as infections, psoriasis, or other skin conditions)

Anti-TNF levels (medication levels) in your blood will be measured regularly

5 Study completion

The study will conclude after 48 weeks of monitoring

Your final health assessment will include fecal calprotectin testing and evaluation of your overall condition

Who Can Join the Study?

Age between 12 and 25 years
Have been diagnosed with Crohn’s disease or ulcerative colitis affecting the digestive tract
Currently receiving treatment with either:
- Infliximab every 8 weeks, or
- Adalimumab every 2 weeks
Must be using current anti-TNF medication as first treatment, or if previously used different anti-TNF medication, it was stopped for reasons other than lack of response
Never attempted to extend time between doses of current medication
Must have one of the following:
- Three consecutive stool tests (fecal calprotectin) showing inflammation levels below target values in the past 6 months, or
- A recent examination (endoscopy) within 2 months showing the disease is in remission
No current symptoms of active inflammatory bowel disease, as determined by the medical team
Must provide written informed consent to participate in the study

Who Cannot Join the Study?

Age below 18 years or above 65 years
Current pregnancy or breastfeeding
Active infection or signs of infection
History of allergic reactions to anti-TNF medications (medications that reduce inflammation)
Recent surgery within the past 3 months
Active cancer or history of cancer in the past 5 years
Severe liver disease or abnormal liver function tests
Severe kidney disease or abnormal kidney function
Presence of intestinal strictures (narrowing of the intestine)
Active fistulas (abnormal connections between organs)
Use of other biological medications in the past 3 months
Unstable medical conditions that could interfere with the study
Inability to provide informed consent
History of non-compliance with medical treatment
Participation in another clinical trial within the past 30 days

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Rqiajhvii Zipnvuownj Svgpwugxw	Arnhem	The Netherlands
Uzhfwpvqovkl Mnxjchd Cjfbzzl Gzonjaxnm	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	11.03.2021
Spain	Recruiting	11.03.2021
The Netherlands	Recruiting	11.03.2021

Trial locations

Investigated drugs:

Anti-TNF therapy (Tumor Necrosis Factor inhibitors) is a type of medication used to treat inflammatory bowel disease (IBD). These medications work by blocking a protein in the body that causes inflammation. They help reduce inflammation in the digestive tract and maintain remission in people with IBD. Common anti-TNF medications include adalimumab and infliximab, which are given either as injections under the skin or through an intravenous infusion.

Fecal Calprotectin is not a medication but a monitoring tool used in this trial. It’s a protein marker measured in stool samples that helps doctors track inflammation levels in the intestines. This measurement helps determine how well the treatment is working and guides decisions about adjusting medication doses.

Investigated diseases:

Crohn’s Disease – A chronic inflammatory condition that can affect any part of the digestive tract, from mouth to anus. The disease typically develops gradually, causing inflammation that spreads deep into affected tissues. Common changes include thickening of the intestinal wall, formation of ulcers, and development of patches of inflamed tissue. The inflammation can lead to abdominal pain, diarrhea, fatigue, and unintended weight loss. The condition can also cause complications outside the digestive tract, affecting joints, skin, or eyes.

Ulcerative Colitis – A long-term inflammatory bowel condition that affects the large intestine (colon) and rectum. The disease begins in the rectum and can spread continuously through the colon. The inflammation causes the lining of the colon to develop tiny sores or ulcers that produce mucus and bleed. The condition typically develops over time, with symptoms that may come and go. The main characteristic is inflammation and ulcers in the digestive tract’s innermost lining.

Trial ID:

2024-516277-68-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of adalimumab and infliximab dose adjustment guided by fecal calprotectin monitoring in adolescents and young adults with Crohn’s disease or ulcerative colitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?