Risankizumab in Children With Crohn's Disease (RisaKids)

The goal of this observational study is to to prospectively explore the real life short (12 weeks) and longer term (54 weeks) clinical, biochemical and endoscopic outcomes of risankizumab in pediatric CD.

This is a 1-year prospective multi-center cohort study of children commencing on risankizumab for pediatric CD with 2 years extension for long-term follow-up. The investigators will record clinical manifestations, blood markers and fecal calprotectin, with monitoring for safety signals including infusion and injection site reactions, pyrexia and infections at various intervals as outlined below. The investigators will also include calprotectin monitoring and fecal sample collection for microbiome and serum samples for drug levels. According to available budget, the investigators will also collect fecal and serum samples for metabolome. Samples collection is optional, thus failure of bio-samples collection will not exclude patients from the study.

Recruiting

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaare Zedek Medical Center

Jerusalem, Israel

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children under the age of 18 years,
Patients diagnosed with CD.
Patients commenced on risankizumab by treating physician (at least one dose), either alone or in combination with any other CD medications, at any stage of the disease.

Exclusion criteria

There will be no exclusion criteria to this study.

Treatment and study plan

Risankizumab

Drug

Risankizumab

Primary outcomes

Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54)

Time frame: Through study completion, approximately 3 years

Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) as defined by the fulfilment of all three criteria:

i. Corticosteroids and enteral nutrition free

ii. Clinical remission (i.e. PCDAI<10)

iii. CRP lower than 1 mg/dl (may be substituted by ESR if CRP missing)

Study contacts

Contact information is provided by the study sponsor or research team.

Nataly Kawazba

CONTACT

[email protected]

97225645254

Sponsors and collaborators

Lead sponsor

Shaare Zedek Medical Center

Other

Registry information

Official study title

Risankizumab in Children With Crohn's Disease (RisaKids): A Multi-center PORTO Group Prospective Study

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Mar 7, 2024
Registry last updated: Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting