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

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called Guselkumab in children and teenagers who have certain conditions. These conditions include Juvenile Psoriatic Arthritis, which is a type of arthritis that affects children and causes joint pain and swelling, Ulcerative Colitis, a disease that causes inflammation and sores in the colon, and Crohn’s Disease, which is another type of inflammatory bowel disease that can affect any part of the gastrointestinal tract.

The treatment being studied is Guselkumab, a type of medication known as a monoclonal antibody. This medication is given as an injection under the skin using a pre-filled syringe. The study aims to observe how safe this medication is when used over a long period in young patients with these conditions. Participants in the study will receive the medication and be monitored by healthcare professionals to ensure their safety and to gather information about any side effects they might experience.

The study will take place over a period of time, allowing researchers to collect data on the long-term effects of Guselkumab. Participants will continue to receive the medication as part of their treatment plan, and their health will be regularly checked by the study team. This research is important to understand how well the medication works and how safe it is for children and teenagers with these specific health conditions.

1 joining the study

Participation begins after completing the dosing planned in the primary pediatric guselkumab study.

Continued benefit from guselkumab therapy must be observed by the investigator.

2 medication administration

The medication used in this study is guselkumab, provided as a solution for injection in a pre-filled syringe.

The administration route is subcutaneous use, meaning the injection is given under the skin.

The dosage is 100 mg/mL, but specific frequency and duration of administration are determined by the study protocol.

3 monitoring and safety evaluation

The main objective is to evaluate the long-term safety of guselkumab in pediatric participants with conditions such as juvenile psoriatic arthritis, moderately to severely active ulcerative colitis, or Crohn’s disease.

No primary or secondary endpoints will be collected, focusing solely on safety.

4 study duration

The estimated end date for the study is December 12, 2031.

The recruitment for the study is expected to start on October 21, 2024.

Who Can Join the Study?

  • The patient must have completed the planned treatment in the initial study involving the medication called guselkumab.
  • The patient must have shown improvement from continuing guselkumab treatment, as determined by the doctor overseeing the study.
  • Before joining the study, the patient must either be unable to have children or, if able to have children, must not be sexually active, or must use a very effective form of birth control. This must continue while receiving the study treatment and for 12 weeks after the last dose.
  • The patient’s parent(s) or legal guardian must sign a form indicating they understand the study’s purpose and procedures and agree to let the child participate. Children who can understand the study must also agree to participate. If a child becomes an adult during the study, they will have the chance to sign an adult consent form to continue participating.
  • The patient must be willing and able to follow the lifestyle rules specified in the study plan.

Who Cannot Join the Study?

  • Patients who do not have juvenile psoriatic arthritis (jPsA), moderately to severely active ulcerative colitis (UC), or moderately to severely active Crohn’s disease (CD) cannot participate. These are specific conditions that the study is focusing on.
  • Patients who are not within the age range specified by the study. The study is looking for participants in certain age groups.
  • Patients who are not willing or able to follow the study procedures and requirements.
  • Patients who have other medical conditions that might interfere with the study or pose a risk to their health.
  • Patients who are currently participating in another clinical trial or have recently participated in one.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them or their babies.
  • Patients who have a history of certain infections or diseases that could affect the study results.
  • Patients who have allergies or reactions to the study medication or similar medications.
  • Patients who have used certain medications recently that might interfere with the study treatment.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Hospital Universitario Y Politecnico La Fe Valencia Spain
Centre Hospitalier Universitaire De Lille Lille France
Centro Hospitalar Universitario Sao Joao E.P.E. Porto Portugal
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Universitetssykehuset Nord-Norge HF Tromsø Norway
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Asklepios Klinik Sankt Augustin GmbH Sankt Augustin Germany
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Instytut Pomnik Centrum Zdrowia Dziecka Warsaw Poland
Universidade De Santiago De Compostela Santiago De Compostela Spain
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Vrije Universiteit Brussel Jette Belgium
Ospedale Pediatrico Bambino Gesu’ Rome Italy
MD Korczowski Bartosz Gabinet Lekarski Rzeszow Poland
Hamburger Zentrum für Kinder- und Jugendrheumatologie Hamburg Germany
Nwgxnkbk Iqrctzdg Gyllpvimm Rmxixjplwykn I Rayrnqavqqupb Im Phsce Dr Heaw Mlhl Eaifbedw Rfggqfw Warsaw Poland
Arnsyoxs Ubpseazcgi Hwttijxu Lorenskog Norway
Aldmcvn Omfusglwehl Pstz Gwcbjfgj Xduie Bergamo Italy
Ugbtcijqyt Dbomr Sfcgk Du Rlnh La Shukoqvo Rome Italy
Wcq Wpmbgu Ifi Piafc Pqncbfju Kyoolmy 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 yet recruiting
21.10.2024
France France
Recruiting
21.10.2024
Germany Germany
Recruiting
21.10.2024
Italy Italy
Recruiting
21.10.2024
Norway Norway
Not yet recruiting
21.10.2024
Poland Poland
Recruiting
21.10.2024
Portugal Portugal
Recruiting
21.10.2024
Spain Spain
Recruiting
21.10.2024

Trial locations

Investigated drugs:

Guselkumab is a medication being studied for its long-term safety in children with certain inflammatory conditions. It is used to help manage symptoms in pediatric patients who have moderately to severely active ulcerative colitis, Crohn’s disease, or juvenile psoriatic arthritis. The study aims to understand how safe this medication is for children over an extended period.

Investigated diseases:

Juvenile Psoriatic Arthritis – This is a type of arthritis that affects children and is associated with psoriasis, a skin condition. It causes joint pain, swelling, and stiffness, often accompanied by patches of red, scaly skin. The disease can affect any joint and may lead to joint damage over time. Symptoms can vary in severity and may come and go, with periods of flare-ups and remission. It can also affect the nails and cause changes such as pitting or separation from the nail bed.

Moderately to Severely Active Ulcerative Colitis – This is a chronic inflammatory condition affecting the colon and rectum. It causes inflammation and ulcers in the lining of the large intestine, leading to symptoms like abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of exacerbation and remission. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it involves an abnormal immune response in the gut.

Moderately to Severely Active 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 causes inflammation that can penetrate deep into the layers of the bowel tissue, leading to symptoms such as abdominal pain, severe diarrhea, fatigue, and weight loss. The disease is characterized by periods of active symptoms and remission. Over time, it can lead to complications like strictures, fistulas, or malnutrition. The exact cause is not fully understood, but it involves an abnormal immune response.

Trial ID:
2023-509560-16-00
Protocol code:
CNTO1959ISD3001
Trial Phase:
Therapeutic confirmatory (Phase III)

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