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Recruiting NCT07529236

Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Treatment Was Switched to Ustekinumab Due to Paradoxical Psoriasis,

No phase Interventional Chronic Inflammatory Bowel Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: switch of anti TNF for ustekinumab for paradoxical psoriasis..
Who it may be relevant to
Registry conditions: Chronic Inflammatory Bowel Diseases. Basic parameters: 6 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Digestive Evolution of Children With Crohn's Disease or Ulcerative Colitis Whose Anti-TNFα Was Switched to Ustekinumab Due to Paradoxical Psoriasis: Real Life Data

Overview

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.

Interventions

  • Drug switch of anti TNF for ustekinumab for paradoxical psoriasis.
    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

Primary outcome measures

  • Proportion of patients maintaining UC or CD control between anti-TNF-α discontinuation (M0) and 3-6 months of ustekinumab treatment (M3-M6) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: at baseline Month 0]
Secondary outcome measures (4)
  • Specify the dermatological evolution of patients with IBD after stopping anti-TNFα and introduction of ustekinumab for paradoxical psoriasis resistant to usual treatments. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: at Month 6]

Eligibility criteria

Inclusion criteria

  • Patients capable of giving their non-opposition
  • Patient <19 years
  • Diagnosis of IBD established
  • Having received an anti-TNFα for IBD for at least 3 months
  • Having stopped the anti-TNFα for a severe paradoxical psoriasis resistant to usual treatments (topical or systemic) diagnosed by a dermatologist
  • Having received Ustekinumab in relay of the anti-TNFα

Exclusion criteria

  • Patient > 18 years
  • Diagnosis of IBD not confirmed
  • Discontinuation of anti-TNFα for a cause other than psoriasis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Nice — Nice

Identifiers

NCT: NCT07529236 · 25-PP-16 · IDRCB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗