IBD Patients, Originator Treatment, Biosimilar, Switch BackRhoneswitchNCT04422171
A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar
An observational study of IBD Patients, Originator Treatment, Biosimilar, Switch Back, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBD Patients, Originator Treatment, Biosimilar, Switch Back
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2020to 31 Jan 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IBD Patients (Ulcerative Colitis and Crohn's disease) under stable (more than 3 months) steroid free clinical and biological remission with adalimumab.
Who may be able to join
- Documented diagnosis of CD or UC established on the basis of standard clinical, endoscopic and histological criteria at least 3 months prior to inclusion.
- Inactive CD or UC outpatients are defined per clinical assessment as an Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC and/or according to ECCO classification (Sturm 2019) within previous 3 months, demonstrating an adequate clinical remission to ada originator
- May be receiving the following drugs (but must remain on stable dose for 10 weeks):
- Oral 5-aminosalicylates (ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching
- Azathioprine, 6-MP or methotrexate provided the dose has been stable for 4 weeks prior to inclusion (dose must remain stable for 10 weeks after switching)
- Non opposition required
Who cannot join
- Diagnosis of indeterminate colitis, ischaemic colitis, fulminant colitis
- Current use of another TNF inhibitor included (but not limited to) infliximab, certolizumab, golimumab
- Current use of vedolizumab or ustekinumab
- Current use of JAK inhibitors or S1P modulators
- Current use of oral corticosteroids
- Active flaring CD or UC patients defined as a HBI > 4 for CD and a PMS>1 for UC and/or concomitant CS medication
- Pregnancy or breast feeding
- Subject under guardianship or subject deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Nicolas MATTHIEU, NMathieu@chu-grenoble.fr
Nicolas MATHIEU
About this study
Official title: A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed.
Minimizing the switch back is another clinical challenge in the current area of biosimilars. The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.
The primary endpoint is to assess the percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
Read the detailed description
The subject will be include during usual hospital consultation after reviewing inclusion/exclusion criteria and obtain non opposition. Data will be collected during 3 usual hospital consultations: at month 3, month 6, and month 12. The end of study will be at month 12 or at premature termination.
Questionnaires will be done in addition during all usual hospital consultations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.
Percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start19 Jun 2020
- Primary completion18 Jun 2021 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD Patients, Originator Treatment, Biosimilar, Switch BackStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Mathieu, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422171
- Sponsor's protocol ID
- 38RC19.379
- Other IDs
- 2020-A00494-35
- Acronym
- Rhoneswitch
- Status last verified
- Sep 2020
- First submitted
- 4 Jun 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.
- ClinicalTrials.gov ID
- NCT04422171
- Acronym / sponsor ID
- Rhoneswitch / 38RC19.379
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 18 Jun 2021 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 9 Jun 2020 (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.
Biosimilars represent great potential in cost saving and reinvestment opportunities in healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference product in patients with rheumatoid arthritis and psoriasis. No data are currently available in IBD patients. Real-life data are needed.
Minimizing the switch back is another clinical challenge in the current area of biosimilars. The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.
The primary endpoint is to assess the percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
Detailed description
The subject will be include during usual hospital consultation after reviewing inclusion/exclusion criteria and obtain non opposition. Data will be collected during 3 usual hospital consultations: at month 3, month 6, and month 12. The end of study will be at month 12 or at premature termination.
Questionnaires will be done in addition during all usual hospital consultations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- IBD Patients (Ulcerative Colitis and Crohn's disease) under stable (more than 3 months) steroid free clinical and biological remission with adalimumab.
Key inclusion criteria (6 listed)
- Documented diagnosis of CD or UC established on the basis of standard clinical, endoscopic and histological criteria at least 3 months prior to inclusion.
- Inactive CD or UC outpatients are defined per clinical assessment as an Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC and/or according to ECCO classification (Sturm 2019) within previous 3 months, demonstrating an adequate clinical remission to ada originator
- May be receiving the following drugs (but must remain on stable dose for 10 weeks):
- Non opposition required
Key exclusion criteria (8 listed)
- Diagnosis of indeterminate colitis, ischaemic colitis, fulminant colitis
- Current use of another TNF inhibitor included (but not limited to) infliximab, certolizumab, golimumab
- Current use of vedolizumab or ustekinumab
- Current use of JAK inhibitors or S1P modulators
- Current use of oral corticosteroids
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
Magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.
Time frame: 12 months
Percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
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.
Nicolas Mathieu principal investigator
CHU Grenoble Alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD Patients, Originator Treatment, Biosimilar, Switch Back, run by University Hospital, Grenoble at 1 site 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 8 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact NICOLAS MATHIEU (+ 33 4 76 76 55 97, nmathieu@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®. (time frame: 12 months). 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 29 Sep 2020.