Inflammatory Bowel DiseasesDOPERNCT05158517
VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study (DOPER)
An observational study of Inflammatory Bowel Diseases, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 1 site in France.
Trial summary
Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Subcutaneous vedolizumab
- Type of treatment
- Injection or infusion
- How many people
- 349 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2022to 20 Mar 2025
- 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: Age ≥ 18 years old, CD patients (HBI ≤ 4) or UC patients (PMS ≤ 2) with established diagnosis > 6 months treated with vedolizumab IV, agreeing to switch from IV to SC formulation or who have just switched to subcutaneous vedolizumab as part of routine care
Who may be able to join
- Male or female subjects who are more than 18 years of age, on the day of signing informed consent
- Documented diagnosis of IBD, established on the basis of standard clinical, endoscopic and/or histological criteria.
- CD or UC remission defined per clinical assessment as a 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 within previous 3 months
- Currently treated with IV vedolizumab
- Patients agreeing to switch from IV to SC formulation
- Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks):
- Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching
- Azathioprine, 6-Mercaptopurine or methotrexate provided the dose has been stable for 4 weeks prior to inclusion • Each patient is required to provide written informed consent in order to be included in the study
Who cannot join
- Current use of adalimumab, infliximab, golimumab or ustekinumab
- Current use of JAK inhibitors or S1P modulators
- Current use of steroids or within the last three months for IBD
- Treatment with any investigational agent in the past 30 days or five half-lives prior to the screening visit (whichever is longer)
- Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
- Female subjects with pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study
Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.
Objectives : The primary objective of DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.
Read the detailed description
Number of patients : 400 patients in approximatively 31 sites in France. Recrutment period : The trial duration for each patient will be 1 year main. Endpoint : The primary endpoint is to assess the rate of persistence of SC vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab.
Secondary Endpoint :
- Percentage of clinical remission at months 3 and 12, defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients
- Percentage of steroid free clinical remission at month 12
- Percentage of biological remission rates (defined as fecal calprotectin <250 μg/g and C-Reactive-Protein (CRP) <5 mg/L) at month 12
- Percentage of Patient-Reported Outcome 2 (PRO-2, defined as stool frequency and rectal bleeding for UC and stool frequency and abdominal pain for CD) response and remission at month 12
- Percentage of clinical relapse free rates at month 12
- Percentage of loss of response rates at month 12
- Mean change from baseline in PMS or HBI, CRP and fecal calprotectin compared to month 12
- Percentage of patients who switch back to previous IV vedolizumab therapy at month 12after switching from IV vedolizumab to SC vedolizumab
- Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with IV and SC vedolizumab
- Persistence of SC vedolizumab at month 12 in patients previously treated by IV vedolizumab every 4 weeks, compared to patients treated by IV vedolizumab every 8 weeks
- Twelve-month cumulative surgery rates
- Hospitalization rate at month 12
- Cumulative infection rate at month 12
- Cumulative injection reactions at month 12
- Cumulative adverse events (AEs) rate at month 12
- Comparison between incidence of specific anti-drug antibodies and incidence of AEs
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Subcutaneous vedolizumab
- Keywords
- IBD UC
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous vedolizumabDrug
Patients will be switched from IV vedolizumab into subcutaneous vedolizumab
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous vedolizumab dosage after switch
To describe subcutaneous vedolizumab persistence after the switch from IV vedolizumab to SC vedolizumab at month 12
Measured: Month 12
Efficacy of subcutaneous vedolizumab treatment in clinical remission
Steroid-free clinical remission 12 months after switching
Measured: Month 12
Safety of subcutaneous vedolizumab treatment
Proportion of participants with treatment-related adverse events for a period of 12 months after swiching
Measured: Month 12
Secondary outcomes (10)
Ratio efficacy of SC vedolizumab in clinical remission
Percentage of patients on steroid free clinical remission at month 12 after switch :
Steroid-free Clinical remission is defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients
Measured: Month 12
Loss of response to vedolizumab SC treatment
Percentage of patients who switch back to originator previous therapy IV vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab in IBD patient
Measured: Month 12
Efficacy of SC vedolizumab treatment on patient quality of life
Percentage of PRO2 response and remission at month 12
Measured: Month 12
Efficacy of SC vedolizumab treatment in biological remission
Percentage of biological remission rates (FC<250μg/g, CRP<5mg/L) at month 12
Measured: Month 12
Efficacy of SC vedolizumab treatment in preventing relapse
Percentage of clinical relapse free rates at month 12
Measured: Month 12
Efficacy of SC vedolizumab treatment in preventing loss of response
Percentage of loss of response rates at month 12
Measured: Month 12
Loss of clinical response
Percentage of clinical response and remission at month 3
Measured: Month 3
Disease activity
Mean change from baseline in :
- For Crohn Disease : HBI (Harvey Bradshow Index)
- For Ulcerative Colitis : PMS (Partiel Mayo Score)
- Biological criteria : CRP (mg/L) : Remission < 5 mg CRP in 1 litre of blood and fecal calprotectin (μg/g) : remission < 250 μg of fecal calprotectin in 1g of stool HBI score, PMS score, CRP ad calprotectin fecal will be combined to report the disease activity (this outcome is expressed without units)
Measured: Moth 12
Treatment adherence
Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with original and SC vedolizumab
Measured: Month 12
Medication Possession Ratio (MPR)
Adherence to biosimilar switch during the follow-up : MPR ratios
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 posted15 Dec 2021
- Study start20 Mar 2022
- Primary completion31 Mar 2024
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158517
- Sponsor's protocol ID
- GT-2021-04
- Acronym
- DOPER
- Status last verified
- Jul 2024
- First submitted
- 2 Dec 2021
- Last updated
- 22 Jul 2024
- 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Multicenter Study
- ClinicalTrials.gov ID
- NCT05158517
- Acronym / sponsor ID
- DOPER / GT-2021-04
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- IBD UC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 15 Dec 2021 (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.
Descriptive : A 12-months multicenter, observational, prospective cohort study. Population : IBD patients under stable clinical and biological remission will be proposed to switch from the IV vedolizumab to the SC vedolizumab as part of routine care. All consecutive IBD patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.
Objectives : The primary objective of DOPER study is to describe SC vedolizumab persistence after switching from IV vedolizumab to SC vedolizumab at month 12.
Detailed description
Number of patients : 400 patients in approximatively 31 sites in France. Recrutment period : The trial duration for each patient will be 1 year main. Endpoint : The primary endpoint is to assess the rate of persistence of SC vedolizumab at month 12 after switching from IV vedolizumab to SC vedolizumab.
Secondary Endpoint :
- Percentage of clinical remission at months 3 and 12, defined as a Partial Mayo Score (PMS) <2 with each sub-score (stool frequency, rectal bleeding, and physician rating of disease activity) of 1 or less for UC patients and as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients
- Percentage of steroid free clinical remission at month 12
- Percentage of biological remission rates (defined as fecal calprotectin <250 μg/g and C-Reactive-Protein (CRP) <5 mg/L) at month 12
- Percentage of Patient-Reported Outcome 2 (PRO-2, defined as stool frequency and rectal bleeding for UC and stool frequency and abdominal pain for CD) response and remission at month 12
- Percentage of clinical relapse free rates at month 12
- Percentage of loss of response rates at month 12
- Mean change from baseline in PMS or HBI, CRP and fecal calprotectin compared to month 12
- Percentage of patients who switch back to previous IV vedolizumab therapy at month 12after switching from IV vedolizumab to SC vedolizumab
- Proportion of patients with positive antibodies (VDZ, ANA) comparing therapy with IV and SC vedolizumab
- Persistence of SC vedolizumab at month 12 in patients previously treated by IV vedolizumab every 4 weeks, compared to patients treated by IV vedolizumab every 8 weeks
- Twelve-month cumulative surgery rates
- Hospitalization rate at month 12
- Cumulative infection rate at month 12
- Cumulative injection reactions at month 12
- Cumulative adverse events (AEs) rate at month 12
- Comparison between incidence of specific anti-drug antibodies and incidence of AEs
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
- Age ≥ 18 years old, CD patients (HBI ≤ 4) or UC patients (PMS ≤ 2) with established diagnosis > 6 months treated with vedolizumab IV, agreeing to switch from IV to SC formulation or who have just switched to subcutaneous vedolizumab as part of routine care
Key inclusion criteria (8 listed)
- Male or female subjects who are more than 18 years of age, on the day of signing informed consent
- Documented diagnosis of IBD, established on the basis of standard clinical, endoscopic and/or histological criteria.
- CD or UC remission defined per clinical assessment as a 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 within previous 3 months
- Currently treated with IV vedolizumab
- Patients agreeing to switch from IV to SC formulation
Key exclusion criteria (6 listed)
- Current use of adalimumab, infliximab, golimumab or ustekinumab
- Current use of JAK inhibitors or S1P modulators
- Current use of steroids or within the last three months for IBD
- Treatment with any investigational agent in the past 30 days or five half-lives prior to the screening visit (whichever is longer)
- Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous vedolizumabPatients will be switched from IV vedolizumab into subcutaneous vedolizumab | Drug | – |
Primary outcome
Subcutaneous vedolizumab dosage after switch
Time frame: Month 12
To describe subcutaneous vedolizumab persistence after the switch from IV vedolizumab to SC vedolizumab at month 12
Efficacy of subcutaneous vedolizumab treatment in clinical remission
Time frame: Month 12
Steroid-free clinical remission 12 months after switching
Safety of subcutaneous vedolizumab treatment
Time frame: Month 12
Proportion of participants with treatment-related adverse events for a period of 12 months after swiching
10 secondary outcomes
Ratio efficacy of SC vedolizumab in clinical remission
Time frame: Month 12
Loss of response to vedolizumab SC treatment
Time frame: Month 12
Efficacy of SC vedolizumab treatment on patient quality of life
Time frame: Month 12
Efficacy of SC vedolizumab treatment in biological remission
Time frame: Month 12
Efficacy of SC vedolizumab treatment in preventing relapse
Time frame: Month 12
Efficacy of SC vedolizumab treatment in preventing loss of response
Time frame: Month 12
Loss of clinical response
Time frame: Month 3
Disease activity
Time frame: Moth 12
Treatment adherence
Time frame: Month 12
Medication Possession Ratio (MPR)
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Bowel Diseases, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives 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 8 inclusion and 6 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 22 Jul 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous vedolizumab dosage after switch (time frame: Month 12). The study lists 3 primary outcomes in all. 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 2024.