NCT Number: NCT07077681
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:
* To describe the factors associated with the maintenance of the biosimilar * To evaluate the evolution of patients' quality of life * To assess the rate of maintenance of clinical remission at M12 * To describe the acceptability of the biosimilar treatment by patients * To evaluate patient satisfaction * To evaluate treatment tolerance * To describe the reasons for treatment discontinuation that occurred during follow-up * To describe the profile of patients who discontinued treatment upon their request.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Cabinet Medical, Amiens, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Month 12
The maintenance of treatment is defined by the continuation of treatment with Uzpruvo®, the biosimilar of ustekinumab, during the twelve months of the study.
Time frame: Inclusion
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.
Time frame: Month 3
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.
Time frame: Month 6
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.
Time frame: Month 12
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.
Time frame: Inclusion
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.
Time frame: Month 3
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.
Time frame: Month 6
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.
Time frame: Month 12
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.
Time frame: Inclusion
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.
Time frame: Month 3
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.
Time frame: Month 6
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.
Time frame: Month 12
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.
Time frame: Inclusion
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.
Time frame: Month 3
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.
Time frame: Month 6
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.
Time frame: Month 12
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.
Time frame: Inclusion
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Time frame: Month 3
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Time frame: Month 6
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Time frame: Month 12
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Time frame: Inclusion
The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency.
Time frame: Month 3
The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency.
Time frame: Month 6
The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency.
Time frame: Month 12
The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency.
EG Labo
Industry
Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
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