CHU de Nice
Nice, France, 06000
Location status: Recruiting
Location contact
Christine CHIAVERINI, Doctor
CONTACT
Christine CHIAVERINI, Doctor
PRINCIPAL_INVESTIGATOR
Thomas HUBICHE, Doctor
SUB_INVESTIGATOR
NCT Number: NCT07529236
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.
Interested in participating?
Request Info6 year–17 year
All sexes
Interventional
Not applicable
Nice, France, 06000
Location status: Recruiting
Christine CHIAVERINI, Doctor
CONTACT
Christine CHIAVERINI, Doctor
PRINCIPAL_INVESTIGATOR
Thomas HUBICHE, Doctor
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: at baseline Month 0
Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity Index 0 to 100)
Time frame: at Month 6
Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index 0 to 65).
Time frame: at baseline Month 0
Severity scores for Crohn disease (PCDAI: The Pediatric Crohn's Disease Activity 0 to 100)
Time frame: at baseline Month 0
Severity scores for ulcerative colitis (PUCAI: Pediatric Ulcerative Colitis Activity Index0 to 65).
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
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.
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.
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
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
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
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.