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NCT Number: NCT07529236

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

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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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, France, 06000

Location status: Recruiting

Location contact

Christine CHIAVERINI, Doctor

CONTACT

[email protected]

0492034702

Christine CHIAVERINI, Doctor

PRINCIPAL_INVESTIGATOR

Thomas HUBICHE, Doctor

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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

Primary outcomes

  1. 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

    Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity Index 0 to 100)

  2. 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

    Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index 0 to 65).

  3. 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

    Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity 0 to 100)

  4. 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

    Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index0 to 65).

Secondary outcomes

  1. 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

    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

  2. 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

    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.

  3. 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

    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.

  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 Month 6

    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

Study contacts

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

Christine Chiaverini, Dr

CONTACT

[email protected]

04 92 03 47 02

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Acronym: INFLISWITCH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Jun 25, 2026

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.