Crohn's Disease
Conditions
Brief summary
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
Interventions
None listed
Sponsors
Kazakhstan Scientific Society for Study of intestine diseases
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index | at week 24 of therapy |
Secondary
| Measure | Time frame |
|---|---|
| Dynamics of vitamin B9 parameters | at 24 and 52 weeks |
| Dynamics of Nutritional Risk Index indicators | at 24 and 52 weeks |
| Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index | at 12 and 52 weeks of therapy |
| Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease | at 24 and 52 weeks |
| Dynamics of fecal calprotectin levels | at 24 and 52 weeks |
| Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity | at 12 and 52 weeks |
| Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire | at 12, 24 and 52 weeks |
| Dynamics of antibody synthesis to the drug Ustekinumab | at 0/1, 24 and 52 weeks |
| List of medications indicated in the general scheme with Odeston | through study completion, an average of 1 year |
| Dynamics of assessing patient adherence to treatment using the Morisky-Green scale | at 0/1, 12, 24 and 52 weeks |
| Collection of information on adverse reactions and/or registration of pregnancy cases | through study completion, an average of 1 year |
| Dynamics of serum iron-binding capacity parameters | at 24 and 52 weeks |
| Dynamics of hemoglobin parameters | at 24 and 52 weeks |
| Dynamics of platelet parameters | at 24 and 52 weeks |
| Dynamics of leukocyte parameters with leukocyte formula | at 24 and 52 weeks |
| Dynamics of erythrocyte sedimentation rate parameters | at 24 and 52 weeks |
| Dynamics of potassium parameters | at 24 and 52 weeks |
| Dynamics of sodium parameters | at 24 and 52 weeks |
| Dynamics of C-reactive protein parameters | at 24 and 52 weeks |
| Dynamics of albumin parameters | at 24 and 52 weeks |
| Dynamics of total protein parameters | at 24 and 52 weeks |
| Dynamics of serum iron parameters | at 24 and 52 weeks |
| Dynamics of red blood cell parameters | at 24 and 52 weeks |
Countries
Kazakhstan
Contacts
Primary ContactKanat Khazhidinov
Backup ContactYekaterina Sakhabutdinova
Outcome results
None listed