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NCT Number: NCT06523647
Clinical Efficacy of Ustekinumab in Crohn's Disease
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
NJSC "West Kazakhstan Marat Ospanov Medical University", Aktobe, Kazakhstan
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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 therapy
Secondary outcomes
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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 therapy
-
Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease
Time frame: at 24 and 52 weeks
-
Dynamics of fecal calprotectin levels
Time frame: at 24 and 52 weeks
-
Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity
Time frame: at 12 and 52 weeks
-
Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire
Time frame: at 12, 24 and 52 weeks
-
Dynamics of antibody synthesis to the drug Ustekinumab
Time frame: at 0/1, 24 and 52 weeks
-
List of medications indicated in the general scheme with Odeston
Time frame: through study completion, an average of 1 year
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Dynamics of assessing patient adherence to treatment using the Morisky-Green scale
Time frame: at 0/1, 12, 24 and 52 weeks
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Collection of information on adverse reactions and/or registration of pregnancy cases
Time frame: through study completion, an average of 1 year
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Dynamics of red blood cell parameters
Time frame: at 24 and 52 weeks
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Dynamics of hemoglobin parameters
Time frame: at 24 and 52 weeks
-
Dynamics of platelet parameters
Time frame: at 24 and 52 weeks
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Dynamics of leukocyte parameters with leukocyte formula
Time frame: at 24 and 52 weeks
-
Dynamics of erythrocyte sedimentation rate parameters
Time frame: at 24 and 52 weeks
-
Dynamics of potassium parameters
Time frame: at 24 and 52 weeks
-
Dynamics of sodium parameters
Time frame: at 24 and 52 weeks
-
Dynamics of C-reactive protein parameters
Time frame: at 24 and 52 weeks
-
Dynamics of albumin parameters
Time frame: at 24 and 52 weeks
-
Dynamics of total protein parameters
Time frame: at 24 and 52 weeks
-
Dynamics of serum iron parameters
Time frame: at 24 and 52 weeks
-
Dynamics of serum iron-binding capacity parameters
Time frame: at 24 and 52 weeks
-
Dynamics of vitamin B9 parameters
Time frame: at 24 and 52 weeks
-
Dynamics of Nutritional Risk Index indicators
Time frame: at 24 and 52 weeks
Study contacts
Contact information is provided by the study sponsor or research team.
Kanat Khazhidinov
CONTACT
Yekaterina Sakhabutdinova
CONTACT
Sponsors and collaborators
Lead sponsor
Kazakhstan Scientific Society for Study of intestine diseases
Other
Registry information
Official study title
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jul 26, 2024
- Registry last updated
- Jul 26, 2024
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.
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