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In a population of adult patients followed for Crohn's disease, who had previously agreed to replace Stelara® with a biosimilar of ustekinumab (Uzpruvo®) and were followed over a period of 12 months under usual medical practice conditions.
Main objective: To assess the maintenance of the biosimilar of ustekinumab at 12 months without returning to the reference treatment
Secondary objectives:
This is an open-label, prospective, longitudinal, multicenter, observational cohort study involving a population of adult patients for whom the investigating physician, prior to inclusion, decided with their consent to replace Stelara® with Uzpruvo® (a biosimilar of ustekinumab).
This observational study does not alter the physician-patient relationship or standard patient care. Physicians retain freedom in their prescriptions and follow-up procedures; no specific procedures or tests are required of patients beyond the completion of self-assessment questionnaires. The study is longitudinal, and the proposed assessments remain within the framework of the patients' standard follow-up with their physician.
This study is classified as RIPH 3 (minimally or not at all interventional).
The conduct of the treatment (dosage, administration schedule, etc.) is left to the discretion of the investigating physician in compliance with the MA, according to their clinical practice and the patient's therapeutic history. Similarly, the investigating physician remains the sole judge of the continuation or interruption of ustekinumab or its replacement by another biotherapy or by any other treatment. All treatments associated with ustekinumab as part of the management of the condition that prompted biotherapy that will be prescribed during the study must be reported in the observation log.
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| Measure | Description | Time Frame |
|---|---|---|
| maintenance of treatment | The maintenance of treatment is defined by the continuation of treatment with Uzpruvo®, the biosimilar of ustekinumab, during the twelve months of the study. | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life - SF-36 | The Medical Outcomes Study Short-Form General Health Survey (SF-36) is a generic quality of life questionnaire. It consists of 36 questions concerning the four weeks preceding the survey, divided into eight dimensions: physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental health, limitations due to physical health, and mental health. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with Crohn disease treated by ustekinumab
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Medical | Recruiting | Amiens | 80090 | France |
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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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| Inclusion |
| Quality of life - SF-36 | The Medical Outcomes Study Short-Form General Health Survey (SF-36) is a generic quality of life questionnaire. It consists of 36 questions concerning the four weeks preceding the survey, divided into eight dimensions: physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental health, limitations due to physical health, and mental health. | Month 3 |
| Quality of life - SF-36 | The Medical Outcomes Study Short-Form General Health Survey (SF-36) is a generic quality of life questionnaire. It consists of 36 questions concerning the four weeks preceding the survey, divided into eight dimensions: physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental health, limitations due to physical health, and mental health. | Month 6 |
| Quality of life - SF-36 | The Medical Outcomes Study Short-Form General Health Survey (SF-36) is a generic quality of life questionnaire. It consists of 36 questions concerning the four weeks preceding the survey, divided into eight dimensions: physical activity, life and relationships with others, physical pain, perceived health, vitality, limitations due to mental health, limitations due to physical health, and mental health. | Month 12 |
| Quality of life - EQ-5D-5L | The EQ-5D-5L questionnaire is a European quality of life scale comprising two parts: a first part with questions known as the "EQ-5D descriptive system," supplemented by a visual analog scale, called the "EQ-5D VAS." It consists of a 20 cm line, graduated from 0 to 100, on which the patient must indicate how they assess their current health, with 0 being the worst possible state and 100 the best. | Inclusion |
| Quality of life - EQ-5D-5L | The EQ-5D-5L questionnaire is a European quality of life scale comprising two parts: a first part with questions known as the "EQ-5D descriptive system," supplemented by a visual analog scale, called the "EQ-5D VAS." It consists of a 20 cm line, graduated from 0 to 100, on which the patient must indicate how they assess their current health, with 0 being the worst possible state and 100 the best. | Month 3 |
| Quality of life - EQ-5D-5L | The EQ-5D-5L questionnaire is a European quality of life scale comprising two parts: a first part with questions known as the "EQ-5D descriptive system," supplemented by a visual analog scale, called the "EQ-5D VAS." It consists of a 20 cm line, graduated from 0 to 100, on which the patient must indicate how they assess their current health, with 0 being the worst possible state and 100 the best. | Month 6 |
| Quality of life - EQ-5D-5L | The EQ-5D-5L questionnaire is a European quality of life scale comprising two parts: a first part with questions known as the "EQ-5D descriptive system," supplemented by a visual analog scale, called the "EQ-5D VAS." It consists of a 20 cm line, graduated from 0 to 100, on which the patient must indicate how they assess their current health, with 0 being the worst possible state and 100 the best. | Month 12 |
| Quality of life - SIBDQ | The Short Inflammatory Bowel Disease Questionnaire is the abbreviated, self-administered version of the IBDQ, a quality of life questionnaire specific to IBD. It includes 10 questions exploring four domains: digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbances (3 items), and social function (2 items). As with the IBDQ, each item is assessed on a Likert scale. The total score ranges from 10 to 70. The higher the score, the better the quality of life. | Inclusion |
| Quality of life - SIBDQ | The Short Inflammatory Bowel Disease Questionnaire is the abbreviated, self-administered version of the IBDQ, a quality of life questionnaire specific to IBD. It includes 10 questions exploring four domains: digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbances (3 items), and social function (2 items). As with the IBDQ, each item is assessed on a Likert scale. The total score ranges from 10 to 70. The higher the score, the better the quality of life. | Month 3 |
| Quality of life - SIBDQ | The Short Inflammatory Bowel Disease Questionnaire is the abbreviated, self-administered version of the IBDQ, a quality of life questionnaire specific to IBD. It includes 10 questions exploring four domains: digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbances (3 items), and social function (2 items). As with the IBDQ, each item is assessed on a Likert scale. The total score ranges from 10 to 70. The higher the score, the better the quality of life. | Month 6 |
| Quality of life - SIBDQ | The Short Inflammatory Bowel Disease Questionnaire is the abbreviated, self-administered version of the IBDQ, a quality of life questionnaire specific to IBD. It includes 10 questions exploring four domains: digestive symptoms (3 items), systemic symptoms (2 items), emotional disturbances (3 items), and social function (2 items). As with the IBDQ, each item is assessed on a Likert scale. The total score ranges from 10 to 70. The higher the score, the better the quality of life. | Month 12 |
| Crohn's disease activity | The Harvey-Bradshaw Index is the most widely used tool for assessing Crohn's disease activity in current practice. It comprises five items (general well-being, abdominal pain, number of loose stools per day, abdominal mass, and extradigestive signs). A score < 4 corresponds to inactive disease; a score between 4 and 12 to active disease; a score above 12 to very severe active disease. | Inclusion |
| Crohn's disease activity | The Harvey-Bradshaw Index is the most widely used tool for assessing Crohn's disease activity in current practice. It comprises five items (general well-being, abdominal pain, number of loose stools per day, abdominal mass, and extradigestive signs). A score < 4 corresponds to inactive disease; a score between 4 and 12 to active disease; a score above 12 to very severe active disease. | Month 3 |
| Crohn's disease activity | The Harvey-Bradshaw Index is the most widely used tool for assessing Crohn's disease activity in current practice. It comprises five items (general well-being, abdominal pain, number of loose stools per day, abdominal mass, and extradigestive signs). A score < 4 corresponds to inactive disease; a score between 4 and 12 to active disease; a score above 12 to very severe active disease. | Month 6 |
| Crohn's disease activity | The Harvey-Bradshaw Index is the most widely used tool for assessing Crohn's disease activity in current practice. It comprises five items (general well-being, abdominal pain, number of loose stools per day, abdominal mass, and extradigestive signs). A score < 4 corresponds to inactive disease; a score between 4 and 12 to active disease; a score above 12 to very severe active disease. | Month 12 |
| Abdominal pain | The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options. | Inclusion |
| Abdominal pain | The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options. | Month 3 |
| Abdominal pain | The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options. | Month 6 |
| Abdominal pain | The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options. | Month 12 |
| Intestinal urgency | The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency. | Inclusion |
| Intestinal urgency | The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency. | Month 3 |
| Intestinal urgency | The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency. | Month 6 |
| Intestinal urgency | The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency. | Month 12 |
| Chu de La Côte Basque | Recruiting | Bayonne | 64109 | France |
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| Chu Besançon - Hopital Jean Minjoz | Not yet recruiting | Besançon | 25000 | France |
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| Chu La Cavale Blanche | Recruiting | Brest | France |
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| Chu Montpellier - Hopital Saint Eloi | Recruiting | Montpellier | 34295 | France |
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| Chu Nantes | Recruiting | Nantes | 44093 | France |
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| Clinique Jules Verne | Recruiting | Nantes | France |
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| Institut Des Mici Groupe Hospitalier | Recruiting | Neuilly-sur-Seine | 92200 | France |
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| Chu Lyon Sud | Recruiting | Pierre-Bénite | France |
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| CHU Rouen Normandie | Recruiting | Rouen | 76000 | France |
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| Chu Nancy Brabois | Recruiting | Vandœuvre-lès-Nancy | 54500 | France |
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| D007410 | Intestinal Diseases |