Crohn Disease (CD)NCT07077681
Evaluation of the Acceptability and Therapeutic Maintenance After Substitution of Ustekinumab With a Biosimilar
An observational study of Crohn Disease (CD), run by EG Labo at 11 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- How many people
- 246 participants
- Where
- 11 sitesFrance
- Study dates
- 2 Jun 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient with Crohn disease treated by ustekinumab
Who may be able to join
- Patient aged 18 years or older
- Patient who has agreed to participate in the study and does not oppose the use of their health data
- Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections
- Patients presenting at least one of the following objective criteria: o PCR < 5 mg/l o Calprotectin < 250 μg/g o Harvey-Bradshaw index < 5
- Patient in stable remission (defined by a stable ustekinumab dosage over the last 24 weeks and absence of corticosteroids for at least 3 months)• Patient for whom the investigator physician, prior to inclusion, has decided with their agreement, to replace Stelara® with Uzpruvo®
- Patient having internet access enabling them to complete online questionnaires
Who cannot join
- Patient treated with ustekinumab with intervals between injections less than 8 weeks
- Patients treated with ustekinumab in a pre-filled pen
- Patient included in an interventional clinical trial at the time of inclusion
- Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...)
- Patient under legal protection, under guardianship or under curatorship.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Cabinet Medical
Amiens, 80090
Julien LOREAU, MD, +33 0786853485, Jloreau@yahoo.com
- Recruiting
Chu de La Côte Basque
Bayonne, 64109
Félix GOUTORBE, MD, +33 0559443136, fgoutorbe@ch-cotebasque.fr
- Not yet recruiting
Chu Besançon - Hopital Jean Minjoz
Besançon, 25000
LUCINE VUITTON, MD PhD, +33 03 81 66 89 91, lvuitton@chu-besancon.fr
- Recruiting
Chu La Cavale Blanche
Brest
Catherine NOEL, MD, +33 02 98 34 71 48, catherine.noel@chu-brest.fr
- Recruiting
Chu Montpellier - Hopital Saint Eloi
Montpellier, 34295
Romain ALTWEGG, MD, +33 04 67 33 73 94, r-altwegg@chu-montpellier.fr
- Recruiting
Chu Nantes
Nantes, 44093
Arnaud BOUREILLE, MD PhD, +33 240083152, arnaud.bourreille@chu-nantes.fr
- Recruiting
Clinique Jules Verne
Nantes
Marie FREYSSINET, MD, +33 2 51 17 34 00, marie.freyssinet@gmail.com
- Recruiting
Institut Des Mici Groupe Hospitalier
Neuilly-sur-Seine, 92200
Carmen STEFANESCU, MD, +33 0141430573, carmen.stefanescu@institutdesmici.fr
- Recruiting
Chu Lyon Sud
Pierre-Bénite
Stéphane NANCEY, MD, +33 04 78 86 13 02, stephane.nancey@chu-lyon.fr
- Recruiting
CHU Rouen Normandie
Rouen, 76000
Nicolas Richard, Dr, 00332 32 88 81 01, accueil.hge@chu-rouen.fr
- Recruiting
Chu Nancy Brabois
Vandœuvre-lès-Nancy, 54500
Bénédicte CARON, MD, +33 03 83 15 74 50, b.caron@chru-nancy.fr
About this study
Official title: Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
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.
Read the detailed description
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.
- Conditions
- Crohn Disease (CD)
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 12
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Abdominal pain
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Measured: Inclusion
Abdominal pain
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Measured: Month 3
Abdominal pain
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Measured: Month 6
Abdominal pain
The PRO-2 questionnaire consists of two separate questions (abdominal pain and stool frequency), each with four response options.
Measured: 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.
Measured: Inclusion
Intestinal urgency
The intestinal urgency questionnaire is an 11-point numeric self-assessment scale. The score increases with the severity of the urgency.
Measured: 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.
Measured: 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.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start2 Jun 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EG Labo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077681
- Sponsor's protocol ID
- Etude ATLAS France 2025
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Therapeutic Maintenance of the Biosimilar Ustekinumab After Substitution
- ClinicalTrials.gov ID
- NCT07077681
- Acronym / sponsor ID
- Etude ATLAS France 2025
- Conditions
- Crohn Disease (CD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- EG LaboIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Jul 2025 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Crohn disease treated by ustekinumab
Key inclusion criteria (6 listed)
- Patient aged 18 years or older
- Patient who has agreed to participate in the study and does not oppose the use of their health data
- Patient with moderate to severe Crohn's disease treated with Stelara® in a pre-filled syringe according to the summary of product characteristics (SPC) with intervals of 8 or 12 weeks between injections
- Patients presenting at least one of the following objective criteria: o PCR < 5 mg/l o Calprotectin < 250 μg/g o Harvey-Bradshaw index < 5
- Patient in stable remission (defined by a stable ustekinumab dosage over the last 24 weeks and absence of corticosteroids for at least 3 months)• Patient for whom the investigator physician, prior to inclusion, has decided with their agreement, to replace Stelara® with Uzpruvo®
Key exclusion criteria (5 listed)
- Patient treated with ustekinumab with intervals between injections less than 8 weeks
- Patients treated with ustekinumab in a pre-filled pen
- Patient included in an interventional clinical trial at the time of inclusion
- Patient refusing or unable to comply with the study follow-up procedures (patient unreachable by phone, unable to fill out the self-questionnaire or poorly speaking French...)
- Patient under legal protection, under guardianship or under curatorship.
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
maintenance of treatment
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.
24 secondary outcomes
Quality of life - SF-36
Time frame: Inclusion
Quality of life - SF-36
Time frame: Month 3
Quality of life - SF-36
Time frame: Month 6
Quality of life - SF-36
Time frame: Month 12
Quality of life - EQ-5D-5L
Time frame: Inclusion
Quality of life - EQ-5D-5L
Time frame: Month 3
Quality of life - EQ-5D-5L
Time frame: Month 6
Quality of life - EQ-5D-5L
Time frame: Month 12
Quality of life - SIBDQ
Time frame: Inclusion
Quality of life - SIBDQ
Time frame: Month 3
Quality of life - SIBDQ
Time frame: Month 6
Quality of life - SIBDQ
Time frame: Month 12
Crohn's disease activity
Time frame: Inclusion
Crohn's disease activity
Time frame: Month 3
Crohn's disease activity
Time frame: Month 6
Crohn's disease activity
Time frame: Month 12
Abdominal pain
Time frame: Inclusion
Abdominal pain
Time frame: Month 3
Abdominal pain
Time frame: Month 6
Abdominal pain
Time frame: Month 12
Intestinal urgency
Time frame: Inclusion
Intestinal urgency
Time frame: Month 3
Intestinal urgency
Time frame: Month 6
Intestinal urgency
Time frame: Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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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.
11 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 Disease (CD), run by EG Labo at 11 sites in France.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maintenance of treatment (time frame: Month 12). 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 22 Jul 2025.