Clinical Efficacy of Ustekinumab in Crohn's Disease
ConditionCrohn's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKazakhstan Scientific Society for Study of intestine diseases
About this trial
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years and older;
Patients who were first prescribed Ustekinumab between January 1 and December 31, 2024
Patients who provided written informed consent to participate in the study
Disqualifiers
Clinically significant active infection (active tuberculosis, active viral hepatitis);
Pregnancy and lactation;
A history of clinically significant, in the opinion of the investigator, psychiatric disorders that may interfere with the study procedures and compliance with the drug regimen;
Ulcerative colitis;
Trial population
The study will include male and female patients aged 18 years and older, with a confirmed diagnosis of Crohn's disease, on therapy with the drug Ustekinumab
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index
Time frame
at week 24 of therapySecondary outcomes
1
Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index
Time frame
at 12 and 52 weeks of therapy2
Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease
Time frame
at 24 and 52 weeks3
Dynamics of fecal calprotectin levels
Time frame
at 24 and 52 weeks4
Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity
Time frame
at 12 and 52 weeksSponsors and contacts
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Source ClinicalTrials.gov