Status:
COMPLETED
Predictive Factors of Clinical Response to Ustekinumab in Active Crohn's Disease
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Crohn Disease
Eligibility:
All Genders
18-18 years
Brief Summary
Ustekinumab is a fully human Immune Globulin Gk (IgGk) monoclonal antibody against the common p40 subunit of interleukin-12 and interleukin-23, which are implicated in the pathogenesis of inflammatory...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Man or non pregnant woman
- Diagnostic attested of Crohn's disease
- Active Crohn's disease, with HBI score ≥ 4
- Previous treatment by at least one anti TNF and / or vedolizumab,, with primary non response, secondary loss of response or unacceptable side effects
- Formal indication of treatment by ustekinumab
- Patient informed and not opposed to his participation at the study
Exclusion
- Pregnancy
- Evolutive cancer
- Evolutive and uncontrolled infection
- Psychiatric pathology that could interfere with the follow-up
- Refusal of the patient
Key Trial Info
Start Date :
February 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03351647
Start Date
February 14 2018
End Date
September 23 2019
Last Update
August 24 2022
Active Locations (1)
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1
Centre hospitalier Lyon Sud
Pierre-Bénite, France, 69495