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Clinical Efficacy of Ustekinumab in Crohn's Disease: an Observational Study With Retrospective and Prospective Components.
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications to the use of the drug Ustekinumab per the current instructions:
Participation in an interventional clinical trial.
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kanat Khazhidinov | Contact | +7 707 413 8263 | kanat.khazhidinov@smo-mera.kz | |
| Yekaterina Sakhabutdinova | Contact | +7 707 375 8530 | yekaterina.sakhabutdinova@smo-mera.kz |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NJSC "West Kazakhstan Marat Ospanov Medical University" | Recruiting | Aktobe | Kazakhstan |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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 red blood cell 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 serum iron-binding capacity parameters | at 24 and 52 weeks |
| Dynamics of vitamin B9 parameters | at 24 and 52 weeks |
| Dynamics of Nutritional Risk Index indicators | at 24 and 52 weeks |
| Non-Profit Joint Stock Company "Kazakh National Medical University named after S.D. Asfendiyarov" | Recruiting | Almaty | 055990 | Kazakhstan |
|
| State-owned public enterprise with the right of economic management "Multidisciplinary City Hospital No. 1" of the Akimat of Astana | Recruiting | Astana | Kazakhstan |
|
| State-owned public enterprise with the right of economic management "Regional Clinical Hospital" of the Health Department of the Turkestan Region | Recruiting | Shymkent | Kazakhstan |
|
| D007410 | Intestinal Diseases |