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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Experimental | Induction regimen: 0,4,8 IV and then every 8 weeks sc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Risankizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Co-primary outcomes: Complete remission at end of remission (weeks 12 and week 54) | 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) | Through study completion, approximately 3 years |
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Inclusion Criteria:
Exclusion Criteria:
* There will be no exclusion criteria to this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nataly Kawazba | Contact | 97225645254 | natalyk@szmc.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaare Zedek Medical Center | Recruiting | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| D007410 | Intestinal Diseases |