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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Registry Identifier | 2025-A02064-45 |
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Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). They cause abdominal pain and chronic diarrhea and/or rectal bleeding, which can lead to weight loss and malnutrition. IBD affects people of all ages but usually appears before the age of 30, most often between the ages of 14 and 24. Childhood IBD is generally considered to be more progressive than adult IBD. Although there is no cure for IBD, many medications can help reduce inflammation and relieve IBD symptoms. Anti-TNF drugs (infliximab and adalimumab) are used early in high-risk patients or when standard treatments have failed. Cutaneous side effects are common in pediatrics (>10%), primarily psoriasiform eruptions (41%), often exudative, affecting skin folds and scalp, recurrent skin infections (20%), and eczematous eruptions (10%). Only 5% of patients need to discontinue treatment due to these side effects. In such cases, the recommended treatment is ustekinumab (European guidelines). While this treatment has been described as effective in patients who have failed anti-TNFα therapy, little data is available on the gastrointestinal and dermatological outcomes of patients on anti-TNFα therapy who switch to ustekinumab for dermatological reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ustekinumab | Other | switch of anti TNF for ustekinumab for paradoxical psoriasis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| switch of anti TNF for ustekinumab for paradoxical psoriasis. | Drug | After traitement 6 months of ustekinumab the patients are inclued in the study and the Medical file are used to complete the CRF. no specific intervention in the study |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) | Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity Index 0 to 100) | at baseline Month 0 |
| Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) | Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index 0 to 65). | at Month 6 |
| Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) | Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity 0 to 100) | at baseline Month 0 |
| Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) | Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index0 to 65). | at baseline Month 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. | The digestive status of patients will be assessed by disease-specific severity scales, namely the Pediatric Crohn's Disease Activity (PCDAI)(from 0 to 100) for patients with Crohn's disease | at baseline Month 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Chiaverini, Dr | Contact | 04 92 03 47 02 | chiaverini.c@chu-nice.fr |
| Name | Affiliation | Role |
|---|---|---|
| Christine CHIAVERINI | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Recruiting | Nice | France | 06000 | France |
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retrospective and case only
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| Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. | The digestive status of patients will be assessed by disease-specific severity scales, Pediatric Ulcerative Colitis Activity Index (PUCAI) (from 0 to 85) for children with UC. | at Month 6 |
| Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. | The digestive status of patients will be assessed by disease-specific severity scales, Pediatric Ulcerative Colitis Activity Index : PUCAI (from 0 to 85) for children with UC. | at baseline Month 0 |
| Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. | The digestive status of patients will be assessed by disease-specific severity scales, namely the Pediatric Crohn's Disease Activity (PCDAI) (from 0 to 100) for patients with Crohn's disease | at Month 6 |
| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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