Crohn's DiseaseNCT06523647
Clinical Efficacy of Ustekinumab in Crohn's Disease
An observational study of Crohn's Disease, run by Kazakhstan Scientific Society for Study of intestine diseases at 4 sites in Kazakhstan.
Trial summary
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 150 participants
- Where
- 4 sitesKazakhstan
- Study dates
- 27 Jun 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
Kazakhstan4 sites, 4 recruiting
- Recruiting
NJSC "West Kazakhstan Marat Ospanov Medical University"
Aktobe
Aset Kaliev, +7 (7132) 563425, info@.zkmu.kz
- Recruiting
Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov"
Almaty, 055990
Marat Shoranov, +7(727)338-70-90, info@kaznmu.kz
- Recruiting
State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana
Astana
Marat Abduov, +7(7172) 27 20 28, gb1-astana@mail.ru
- Recruiting
State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region
Shymkent
Zhanbolat Dildabekov, +7 (7252) 53 78 99, gkkp-okb@mail.ru
About this study
Official title: Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
- Conditions
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with a reduced level of disease activity by 30% or more according to the Crohn's Disease Activity Index
Measured: at week 24 of therapy
Secondary outcomes (23)
Proportion of patients with a 30% or more reduction in disease activity according to the Crohn's Disease Activity Index
Measured: at 12 and 52 weeks of therapy
Proportion of patients in endoscopic remission based on Simple Endoscopic Score for Crohn's Disease
Measured: at 24 and 52 weeks
Dynamics of fecal calprotectin levels
Measured: at 24 and 52 weeks
Proportion of patients with normalization of Magnetic resonance enterography based on the Magnetic Resonance Index of Activity
Measured: at 12 and 52 weeks
Dynamics of quality of life assessment based on the Short Inflammatory Bowel Disease Questionnaire
Measured: at 12, 24 and 52 weeks
Dynamics of antibody synthesis to the drug Ustekinumab
Measured: at 0/1, 24 and 52 weeks
List of medications indicated in the general scheme with Odeston
Measured: through study completion, an average of 1 year
Dynamics of assessing patient adherence to treatment using the Morisky-Green scale
Measured: at 0/1, 12, 24 and 52 weeks
Collection of information on adverse reactions and/or registration of pregnancy cases
Measured: through study completion, an average of 1 year
Dynamics of red blood cell parameters
Measured: at 24 and 52 weeks
Dynamics of hemoglobin parameters
Measured: at 24 and 52 weeks
Dynamics of platelet parameters
Measured: at 24 and 52 weeks
Dynamics of leukocyte parameters with leukocyte formula
Measured: at 24 and 52 weeks
Dynamics of erythrocyte sedimentation rate parameters
Measured: at 24 and 52 weeks
Dynamics of potassium parameters
Measured: at 24 and 52 weeks
Dynamics of sodium parameters
Measured: at 24 and 52 weeks
Dynamics of C-reactive protein parameters
Measured: at 24 and 52 weeks
Dynamics of albumin parameters
Measured: at 24 and 52 weeks
Dynamics of total protein parameters
Measured: at 24 and 52 weeks
Dynamics of serum iron parameters
Measured: at 24 and 52 weeks
Dynamics of serum iron-binding capacity parameters
Measured: at 24 and 52 weeks
Dynamics of vitamin B9 parameters
Measured: at 24 and 52 weeks
Dynamics of Nutritional Risk Index indicators
Measured: at 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start27 Jun 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kazakhstan Scientific Society for Study of intestine diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523647
- Sponsor's protocol ID
- KSSSID-01-23
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components
- ClinicalTrials.gov ID
- NCT06523647
- Acronym / sponsor ID
- KSSSID-01-23
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Kazakhstan Scientific Society for Study of intestine diseasesUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Contraindications to the use of the drug Ustekinumab per the current instructions:
- Participation in an interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
23 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Kazakhstan Scientific Society for Study of intestine diseases at 4 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kanat Khazhidinov (+7 707 413 8263, kanat.khazhidinov@smo-mera.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.