Study on Long-term Safety of Ustekinumab for Children with Crohn’s Disease, Juvenile Psoriatic Arthritis, or Ulcerative Colitis

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called ustekinumab, which is used to treat certain inflammatory diseases in children and teenagers aged 2 to under 18 years. The diseases being studied include Crohn’s Disease, Juvenile Psoriatic Arthritis, and Ulcerative Colitis. These conditions are characterized by inflammation in different parts of the body, such as the digestive tract and joints. The medication, known by the brand name Stelara, is given as a solution for injection under the skin.

The purpose of this study is to gather information on the long-term safety of ustekinumab in young patients who have already participated in a previous study with this medication. Participants will continue to receive the medication over a period of time, and their health will be monitored to ensure the treatment remains safe. The study will involve regular check-ups and assessments to track any side effects or changes in the participants’ conditions.

Throughout the study, researchers will pay close attention to any adverse events, which are unexpected medical problems that may occur during treatment. They will also monitor for any reactions at the injection site and any changes in the participants’ health that might indicate a worsening of their disease. The study aims to provide valuable information about the long-term use of ustekinumab in managing these chronic conditions in young patients.

1 joining the study

Upon joining the study, the participant must have completed the dosing planned in the primary pediatric ustekinumab study. The participant should have shown a benefit from continued ustekinumab therapy, such as a clinical response or remission, as defined in the primary study.

2 informed consent

The parent(s), legal guardian(s), or legally acceptable representative must sign an informed consent form (ICF) indicating understanding of the study’s purpose and procedures. Children capable of understanding the study, typically aged 7 and older, must also provide assent. Adolescents reaching the age of majority during the study will have the opportunity to sign an adult ICF.

3 medication administration

The participant will receive ustekinumab, which is administered as a solution for injection. The medication is given through subcutaneous use, meaning it is injected under the skin. The specific dosage and frequency will be determined based on the participant’s previous treatment in the primary study.

4 monitoring and assessments

Throughout the study, the participant will be monitored for any adverse events (AEs), serious adverse events (SAEs), and any reactions at the injection site. Regular clinical laboratory tests, including hematology and chemistry, will be conducted to ensure safety. The participant’s condition will be assessed to check for any worsening of the disease or need for additional therapy.

5 study duration

The study is a long-term extension, estimated to end by December 15, 2027. The participant will continue to receive treatment and monitoring as outlined in the study protocol until the study concludes or until it is determined that the participant should discontinue for any reason.

Who Can Join the Study?

  • Must be a male or female between the ages of 2 and 17 years old.
  • Must have completed the planned treatment in the initial pediatric study with ustekinumab, which is a type of medication.
  • Must have shown a benefit from continuing ustekinumab treatment, meaning there was a positive response or improvement in their condition as determined in the initial study.
  • A parent, legal guardian, or legally acceptable representative must sign a form indicating they understand the study and agree to allow the child to participate. This is called an Informed Consent Form (ICF).
  • Children who are capable of understanding the study, usually those 7 years and older, must also agree to participate. This is called giving assent.
  • If a child reaches adulthood during the study, they will have the chance to sign an adult consent form to continue participating.

Who Cannot Join the Study?

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent infection that required treatment with antibiotics.
  • Patients who have received any other investigational drug within the last 30 days.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients with certain blood disorders or abnormalities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario Y Politecnico La Fe Valencia Spain
Katholieke Universiteit te Leuven Leuven Belgium
Hopital Necker Enfants Malades Paris France

Other Sites

Site Name City Country Status
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Semmelweis University Budapest Hungary
University Of Debrecen Debrecen Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhaza Hungary
Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz Miskolc Hungary
Gastromed Sp. z o.o. Torun Poland
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Aachen AöR Aachen Germany
Deutsches Herzzentrum Berlin Berlin Germany
Vrije Universiteit Brussel Jette Belgium
University Childrens Hospital Queen Fabiola Brussels Belgium
Uniwersytecki Szpital Dzieciecy W Krakowie Cracow Poland
University Of Szeged Szeged Hungary
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
Lywceg Mwvudxknpq Umaswcnopb Om Mcmlgw Munich Germany
Cxfiavyhz Uiqermhipsjzqq Saydkgadn Woluwe-Saint-Lambert Belgium
Hykyunws Dw Ls Sscwj Cups I Sktt Psg Barcelona Spain
Uimnswaxdtmtdnhdvxlty Etlmy Aql Essen Germany
Wzl Wwgxbb Ihh Pcsqr Plmtwduu Khkqvts Warsaw Poland

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
23.08.2021
France France
Not recruiting
23.08.2021
Germany Germany
Not recruiting
23.08.2021
Hungary Hungary
Not recruiting
23.08.2021
Italy Italy
Not recruiting
23.08.2021
Poland Poland
Not recruiting
23.08.2021
Spain Spain
Not recruiting
23.08.2021

Trial locations

Investigated drugs:

Ustekinumab is a medication used in this clinical trial. It is designed to help manage certain inflammatory conditions by targeting specific proteins in the immune system that can cause inflammation. This medication is often used to treat conditions like psoriasis, psoriatic arthritis, and Crohn’s disease. In this trial, the focus is on understanding the long-term safety of using Ustekinumab in children and teenagers who are between 2 and 18 years old. The goal is to see how well the medication works over a longer period and to ensure it is safe for young patients to use. Participants in the trial will receive Ustekinumab to help control their symptoms and improve their quality of life while researchers monitor any side effects or issues that may arise during the study.

Crohn’s Disease – Crohn’s Disease is a chronic inflammatory condition of the gastrointestinal tract. It can affect any part of the digestive system, from the mouth to the anus, but most commonly impacts the end of the small intestine and the beginning of the colon. The inflammation can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease often progresses with periods of remission and flare-ups. Over time, it can cause complications like strictures, fistulas, and abscesses. The exact cause of Crohn’s Disease is unknown, but it involves an abnormal immune response.

Juvenile Psoriatic Arthritis – Juvenile Psoriatic Arthritis is a type of inflammatory arthritis that affects children and is associated with the skin condition psoriasis. It causes joint pain, swelling, and stiffness, often in the fingers and toes, and can also lead to changes in the nails. The disease can progress to involve larger joints and the spine. Symptoms may appear in cycles, with periods of increased activity followed by times of remission. The skin symptoms of psoriasis, such as red patches with silvery scales, may precede or follow the onset of arthritis. The exact cause is not fully understood, but it involves genetic and immune system factors.

Ulcerative Colitis – Ulcerative Colitis is a chronic inflammatory condition that affects the colon and rectum. It causes inflammation and ulcers in the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The progression of Ulcerative Colitis is marked by periods of exacerbation and remission. Over time, it can lead to complications such as severe bleeding, perforation of the colon, and increased risk of colon cancer. The exact cause is unknown, but it involves an abnormal immune response in the gut.

Trial ID:
2022-501067-40-00
Protocol code:
CNTO1275ISD3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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