An observational study in Crohn's Disease, sponsored by Kazakhstan Scientific Society for Study of intestine diseases. Recruiting at 4 sites in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Kazakhstan Scientific Society for Study of intestine diseases · Observational
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 150 is below the median of 185 across 645 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Kazakhstan Scientific Society for Study of intestine diseases is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to the use of the drug Ustekinumab per the current instructions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Dynamics of assessing patient adherence to treatment using the Morisky-Green scale
Time frame: at 0/1, 12, 24 and 52 weeks
Collection of information on adverse reactions and/or registration of pregnancy cases
Time frame: through study completion, an average of 1 year
Dynamics of red blood cell parameters
Time frame: at 24 and 52 weeks
Dynamics of hemoglobin parameters
Time frame: at 24 and 52 weeks
Dynamics of platelet parameters
Time frame: at 24 and 52 weeks
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Kazakhstan Scientific Society for Study of intestine diseases