Clinical trial NCT06523647: Clinical Efficacy of Ustekinumab in Crohn's Disease
Official title: Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Lead sponsor: Kazakhstan Scientific Society for Study of intestine diseases
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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

Brief summary: Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Contraindications to the use of the drug Ustekinumab per the current instructions:

  * 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;
  * Malignant gastrointestinal diseases in history or at the time of inclusion in the study;
  * Decompensated chronic diseases of the liver, kidneys, cardiovascular system, systemic vasculitis, diabetes mellitus;
  * Abuse of alcohol or psychoactive drugs within 1 year before the start of this study (as reported by the patient);
* Participation in an interventional clinical trial.

Primary outcomes:
measure: The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index
timeFrame: at week 24 of therapy
Secondary outcomes:
measure: Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index
timeFrame: at 12 and 52 weeks of therapy
measure: Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease
timeFrame: at 24 and 52 weeks
measure: Dynamics of fecal calprotectin levels
timeFrame: at 24 and 52 weeks
measure: Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity
timeFrame: at 12 and 52 weeks
measure: Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire
timeFrame: at 12, 24 and 52 weeks
measure: Dynamics of antibody synthesis to the drug Ustekinumab
timeFrame: at 0/1, 24 and 52 weeks
measure: List of medications indicated in the general scheme with Odeston
timeFrame: through study completion, an average of 1 year
measure: Dynamics of assessing patient adherence to treatment using the Morisky-Green scale
timeFrame: at 0/1, 12, 24 and 52 weeks
measure: Collection of information on adverse reactions and/or registration of pregnancy cases
timeFrame: through study completion, an average of 1 year
measure: Dynamics of red blood cell parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of hemoglobin parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of platelet parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of leukocyte parameters with leukocyte formula
timeFrame: at 24 and 52 weeks
measure: Dynamics of erythrocyte sedimentation rate parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of potassium parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of sodium parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of C-reactive protein parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of albumin parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of total protein parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of serum iron parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of serum iron-binding capacity parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of vitamin B9 parameters
timeFrame: at 24 and 52 weeks
measure: Dynamics of Nutritional Risk Index indicators
timeFrame: at 24 and 52 weeks
Other outcomes:
Locations:
city: Aktobe
country: Kazakhstan
facility: NJSC "West Kazakhstan Marat Ospanov Medical University"
city: Almaty
country: Kazakhstan
facility: Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"
city: Astana
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana
city: Shymkent
country: Kazakhstan
facility: State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region
Study officials:
References: