Ulcerative ColitisPhase 4EFFICACINCT03679546
EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis
A Phase 4 study testing Infliximab and Vedolizumab Injection in people with Ulcerative Colitis, run by Rennes University Hospital at 19 sites in France.
Trial summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Infliximab and Vedolizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 19 sitesFrance
- Study dates
- 4 Jan 2019to 16 Jun 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Male or non-pregnant female, non-lactating female;
- 18 years of age or older and less than 75 years ;
- Documented diagnosis of UC for at least 6 months ;
- Left side colitis or pancolitis ;
- Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
- Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ;
Show all 23Show fewer
- Ability of the subject to participate fully in all aspects of this clinical trial ;
- Written informed consent must be obtained and documented ;
- Naïve to Janus kinase inhibitor (JAK inhibitor) ;
- Affiliation to the national health insurance.
- Non inclusion Criteria:
- Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ;
- Contraindication to vedolizumab treatment ;
- Steroid treatment > 20 mg/day for at least two weeks before baseline ;
- Proctitis ;
- Stoma ;
- Proctocolectomy or subtotal colectomy ;
- Planned surgery within the year of the trial ;
- Previous exposure to vedolizumab or infliximab ;
- History of cancer during the past 5 years ;
- Pregnancy or breastfeeding
- Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.
- Ongoing participation to another interventional study
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
Centre Hospitalier Universitaire d'Amiens-Picardie
Amiens, 80054
Centre Hospitalier Universitaire de Besançon
Besançon, 25030
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33600
Centre Hospitalier Universitaire de Caen
Caen, 14033
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, 63003
Assistance Publique des Hôpitaux de Paris - Hôpital Beaujon
Clichy, 92110
Assistance Publique des Hôpitaux de Paris - Hôpital Henri Mondor
Créteil, 94000
Centre Hospitalier Universitaire de Lille
Lille, 59037
Hospices Civils de Lyon
Lyon, 69495
Assistance Publique des Hôpitaux de Marseille
Marseille
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34090
Centre Hospitalier Universitaire de Nancy
Nancy, 54500
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Centre Hospitalier Universitaire de Nice
Nice, 06202
Centre Hospitalier Universitaire de Nîmes
Nîmes
Assistance Publique des Hôpitaux de Paris - Hôpital Saint-Louis
Paris, 75010
Centre Hospitalier de Saint-Brieuc
Saint-Brieuc, 22000
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
Centre Hospitalier Universitaire de Toulouse
Toulouse
About this study
Official title: EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.
However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.
Read more
Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.
Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).
Read the detailed description
Design :
A prospective, multicenter, randomized, double blind clinical trial
Primary objective :
To determine whether a non-TNF-targeted biologic (vedolizumab) is superior to infliximab to treat patient with UC losing response or with a primary failure to a first subcutaneous anti-TNF drug at week 14.
Secondary objective :
- To assess the rate of clinical response and remission at Week 54 in each group of treatments and the time to clinical response and remission from baseline ;
- To assess the changes in faecal calprotectin levels from baseline to week 14 and 54 according to treatment ;
- To assess the rate of colectomy and hospitalization in each treatment group ;
- To assess the rate of mucosal healing at week 14 and 54 in each group of treatments ;
- To assess the rate of loss of response in each group of treatments for patients responder after induction phase ;
- To assess the changes of quality of life indexes and the disability index from baseline to week 14 and 54 ;
- To determine the safety profile of each group of treatments ;
- To characterize the response in each group of treatments according to drug monitoring of the first anti-TNF agent ;
- To describe the pharmacokinetics of infliximab and vedolizumab as second-line treatment of UC and explore the sources of pharmacokinetic inter-individual variability ;
- To identify predictive factors of response to the treatment, including pharmacokinetic features
Expected findings and impact:
The patients include in the clinical will not lose any benefit since both treatments are actually indicated and effective in this condition. In both arm of treatment, patients will receive an effective treatment.
The study will optimize physician decision making to decrease the disease activity period in UC patients with known consequence such as hospitalisation, surgery, work cessations with related cost effects.
- Conditions
- Ulcerative Colitis
- Being tested
- Infliximab, Vedolizumab Injection
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Infliximab injection
Infliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks.
Vedolizumab InjectionDrug
Also called Vedolizumab
Vedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | Infliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks. Receives: Drug: Infliximab |
| Vedolizumab | Experimental | Vedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks. Receives: Drug: Vedolizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
The rate of patients with clinical and endoscopic steroid free-remission (Mayo score ≤ 2 without subscore > 1) at week 14
Measured: Week 14
Secondary outcomes (13)
Mayo score
Mayo score at week 54
Measured: Week 54
Faecal calprotectin level
Faecal calprotectin level at week 14 and 54
Measured: At week 14 and 54
Colectomy or hospitalization for disease flare
Colectomy or hospitalization for disease flare during the study period
Measured: through study completion, an average of 1 year
Endoscopic subscore of the mayo Score
Endoscopic subscore of the mayo Score at week 14 and 54 Partial Mayo score at week 2, 6, 14, 54. Endoscopic subscore of the Mayo score : from 0 (better score) to 3 (worse score)
Measured: at week 14 and 54
Partial Mayo score
Partial Mayo score at week 2, 6, 14, 54. Partial Mayo score : from 0 (better score) to 9 (worse score)
Measured: at week 2, 6, 14, 54
Inflammatory Bowel Disease Questionnaire (IBDQ) index
IBDQ index at baseline week 14 and 54
Measured: at baseline week 14 and 54
Inflammatory Bowel Disease-Disk (IBD-Disk)
IBD-Disk at baseline week 14 and 54
Measured: at baseline week 14 and 54
Inflammatory Bowel Disease-Disability Index (IBD-DI)
IBD-DI at baseline week 14 and 54
Measured: at baseline week 14 and 54
Adverse events
Rate and type of adverse events during the study period
Measured: through study completion, an average of 1 year
Last trough concentration of the first subcutaneous agent
Last trough concentration of the first subcutaneous agent at the time of the loss of response
Measured: baseline
anti-drug antibodies concentration
anti-drug antibodies concentration at the time of the loss of response and
Measured: baseline
Blood trough concentration of infliximab or vedolizumab
Trough concentration of infliximab or vedolizumab at each visit and anti-drug antibodies concentration (blood concentration)
Measured: at baseline, weeks 0, 2, 6, 14 and 54
Fecal trough concentration of infliximab or vedolizumab
Trough concentration of infliximab or vedolizumab at each visit and anti-drug antibodies concentration (fecal concentration)
Measured: at baseline, weeks 0, 2, 6, 14 and 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start4 Jan 2019
- Primary completion16 Dec 2024
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, randomized, double blind clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume BOUGUEN, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679546
- Sponsor's protocol ID
- 35RC17_8841_EFFICACI
- Other IDs
- 2018-002673-21, 2018-66-PP, 2018
- Acronym
- EFFICACI
- Status last verified
- Jun 2025
- First submitted
- 18 Sep 2018
- Last updated
- 24 Jun 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03679546
- Acronym / sponsor ID
- EFFICACI / 35RC17_8841_EFFICACI
- Conditions
- Ulcerative Colitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 20 Sep 2018 (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.
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) that results from immune dysregulation. Arguably, the development of Tumor Necrosis Factor (TNF) antagonists (including infliximab, adalimumab and golimumab) revolutionized the management of immune-mediated chronic diseases in the past two decades.
However, about one third of patients will not respond to a first anti-TNF treatment and 10% to 30% will loose response to anti-TNF during the follow-up.
Historically, a switch between anti-TNF was performed to recapture remission and response to anti-TNF. Recently, a new biologic therapy blocking another target has been approved and is now reimbursed during ulcerative colitis, namely vedolizumab. Vedolizumab is an anti-integrin agent avoiding the recruitment of lymphocytes specifically in inflamed gut tissue.
Emerging data suggest that a switch of therapeutic class (meaning a change of biologic target with Non-TNF-targeted biologic) in case of clinical failure or insufficient response to anti-TNF may be the best choice. This idea of a switch out of the anti-TNF class is also supported by data on drug monitoring that may help physician decision making in case of loss of response. However, no trial is currently available and ongoing to assess the best therapeutic strategy. The aim of the proposed study is to assess the best biological based strategy in patient losing response to a first subcutaneous anti-TNF (golimumab and/or adalimumab).
Detailed description
Design :
A prospective, multicenter, randomized, double blind clinical trial
Primary objective :
To determine whether a non-TNF-targeted biologic (vedolizumab) is superior to infliximab to treat patient with UC losing response or with a primary failure to a first subcutaneous anti-TNF drug at week 14.
Secondary objective :
- To assess the rate of clinical response and remission at Week 54 in each group of treatments and the time to clinical response and remission from baseline ;
- To assess the changes in faecal calprotectin levels from baseline to week 14 and 54 according to treatment ;
- To assess the rate of colectomy and hospitalization in each treatment group ;
- To assess the rate of mucosal healing at week 14 and 54 in each group of treatments ;
- To assess the rate of loss of response in each group of treatments for patients responder after induction phase ;
- To assess the changes of quality of life indexes and the disability index from baseline to week 14 and 54 ;
- To determine the safety profile of each group of treatments ;
- To characterize the response in each group of treatments according to drug monitoring of the first anti-TNF agent ;
- To describe the pharmacokinetics of infliximab and vedolizumab as second-line treatment of UC and explore the sources of pharmacokinetic inter-individual variability ;
- To identify predictive factors of response to the treatment, including pharmacokinetic features
Expected findings and impact:
The patients include in the clinical will not lose any benefit since both treatments are actually indicated and effective in this condition. In both arm of treatment, patients will receive an effective treatment.
The study will optimize physician decision making to decrease the disease activity period in UC patients with known consequence such as hospitalisation, surgery, work cessations with related cost effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized, double blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: InfliximabInfliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks. |
| Vedolizumab | Experimental | Drug: Vedolizumab InjectionVedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or non-pregnant female, non-lactating female;
- 18 years of age or older and less than 75 years ;
- Documented diagnosis of UC for at least 6 months ;
- Left side colitis or pancolitis ;
- Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| InfliximabAlso: Infliximab injectionInfliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks. | Drug | Infliximab |
| Vedolizumab InjectionAlso: VedolizumabVedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks. | Drug | Vedolizumab |
Primary outcome
Remission
Time frame: Week 14
The rate of patients with clinical and endoscopic steroid free-remission (Mayo score ≤ 2 without subscore > 1) at week 14
13 secondary outcomes
Mayo score
Time frame: Week 54
Faecal calprotectin level
Time frame: At week 14 and 54
Colectomy or hospitalization for disease flare
Time frame: through study completion, an average of 1 year
Endoscopic subscore of the mayo Score
Time frame: at week 14 and 54
Partial Mayo score
Time frame: at week 2, 6, 14, 54
Inflammatory Bowel Disease Questionnaire (IBDQ) index
Time frame: at baseline week 14 and 54
Inflammatory Bowel Disease-Disk (IBD-Disk)
Time frame: at baseline week 14 and 54
Inflammatory Bowel Disease-Disability Index (IBD-DI)
Time frame: at baseline week 14 and 54
Adverse events
Time frame: through study completion, an average of 1 year
Last trough concentration of the first subcutaneous agent
Time frame: baseline
anti-drug antibodies concentration
Time frame: baseline
Blood trough concentration of infliximab or vedolizumab
Time frame: at baseline, weeks 0, 2, 6, 14 and 54
Fecal trough concentration of infliximab or vedolizumab
Time frame: at baseline, weeks 0, 2, 6, 14 and 54
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 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. This study is not recruiting at the moment.
Guillaume BOUGUEN, MD principal investigator
Rennes University Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab and Vedolizumab Injection in people with Ulcerative Colitis, run by Rennes University Hospital at 19 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 23 inclusion and 0 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: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Remission (time frame: Week 14). 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 24 Jun 2025.