Inflammatory Bowel DiseasesSPACIFIXNCT03841942
Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With IBD in Deep Remission
A study testing clinically-based spacing strategy and Trough level-based strategy in people with Inflammatory Bowel Diseases, run by University Hospital, Montpellier at 16 sites in France.
Trial summary
Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- clinically-based spacing strategy and Trough level-based strategy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 16 sitesFrance
- Study dates
- 26 Jun 2019to 31 Oct 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- Patients with a diagnosis of Crohn's disease or ulcerative colitis according to clinical, biological, morphological and endoscopic criteria defined by the ECCO guidelines22, 23
- Patients in deep remission since at least 6 months17:
- CDAI < 150 for CD, Partial Mayo score < 3 for UC
- CRP (C reactive protein) < 10 mg/l
- CDEIS < 6 (<3 in each segment) for CD, Mayo endoscopic subscore of 0 or 1 for UC
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- For CD patients with small bowel disease: No ulceration on MRI, only asymptomatic fibrotic stenosis without inflammation and retro dilatation. No ulceration on wireless capsule endoscopy if feasible
- For patients with perianal disease: No active draining fistula, or perianal abscess on clinical exam and MRI
- Treatment with infliximab at stable dose (5mg/kg) with a stable interval for at least 4 months
- Infliximab trough level > 3 ug/ml
- No change in other IBD therapies in the past 4 months
- Signed informed consent form
- Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- Subjects must be covered by public health insurance
Who cannot join
- Subject unable to read or/and write
- Planned longer stay outside the region that prevents compliance with the visit plan
- Subject who are in a dependency or employment with the sponsor or the investigator
- Participation in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
- Previous withdrawal or spacing over 8 weeks of infliximab therapy
- Infliximab therapy at 10 mg/kg
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- Patients who have presented a severe acute or delayed reaction to infliximab.
- Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
- Patients with ostomy or ileoanal pouch
- Pregnancy or planned pregnancy during the study
- Inability to follow study procedures as judged by the investigator
- Steroid use ≤3 months prior to screening
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Amiens University Hospital
Amiens
Besançon University Hospital
Besançon
Bordeaux University Hospital
Bordeaux
Caen University Hospital
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Lille University Hospital
Lille
Pineton de Chambrun
Montpellier, 34000
CHRU Nancy - Hôpitaux de Brabois
Nancy
Nantes University Hospital
Nantes
Nice University Hospital
Nice
Nîmes University Hospital
Nîmes
APHP Beaujon Hospital
Paris
APHP Paris Cochin
Paris
Rennes University Hospital
Rennes
Saint Etienne University Hospital
Saint-Etienne
Toulouse University Hospital
Toulouse
About this study
Official title: Comparison of Trough Level-based Spacing and Clinical-based Spacing of Infliximab Infusions in Patients With Inflammatory Bowel Disease in Deep Remission; A Prospective, Multicenter, Open-label, Randomized, Controlled Study
Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study
Read the detailed description
Infliximab (IFX) is common treatment for refractory inflammatory bowel disease (IBD) (5 mg/kg/8 weeks in maintenance). A large majority of IBD patients treated with IFX are currently in long-term clinical remission under maintenance IFX monotherapy or cotherapy with azathioprine or methotrexate. There is no recommendation on optimal duration of anti-TNF therapy once it is started. A key question is to know if the treatment could be stopped/decreased without clinical relapse. Anti-TNF therapy is also a major burden in health care costs in France. Identifying an optimal duration of anti-TNF therapy and criteria for stopping/decreasing could help in lowering these therapies cost without altering disease control. Prospective studies have investigated the withdrawal of IFX in IBD patients showing 50% of clinical relapse at 1 year in patient in clinical remission, 30% in patients in deep remission.
Another alternative to deescalate anti-TNF treatment would be to increase the infusion interval without stopping the drug. Indeed, this infusion interval spacing is strongly requested by patients who seek an improvement in their quality of life. This empirical spacing corresponded to an increase of the infusion interval to 10 weeks then to 12 weeks maximum in patients with persistent clinical remission. In France and in Europe, even if there is no recommendation about infliximab de-escalation and increase of the infusion interval, many physicians have already performed empirically an infliximab infusion interval spacing in IBD patients in longstanding remission while on infliximab maintenance therapy. This empirical infusion interval increase in patients in clinical remission leads to a clinical relapse in 30% of these patients with a median delay of 12.6 months (IQR: 10.4- 18.4) (Dufour et al. UEGW 2017).
Since the last ten years, it was demonstrated that the serum level of infliximab measured just before the last infliximab infusion (defined as a trough level) is correlated to the clinical activity of the disease1. A serum IFX trough level between 3 and 7 ug/ml has been identified as therapeutic with more clinical relapse in patients with IFX < 3 ug/ml and safe dose reduction in patients with IFX trough level > 7 ug/ml.
Thus, we hypothesized that using the determination of serum infliximab trough level could decrease the risk of clinical relapse observed in IBD patients who underwent an empirical infliximab infusion interval spacing (approximatively 30% of the cases). Indeed, in an infliximab trough level-based spacing strategy, only patients with a supratherapeutic (>7ug/ml) infliximab trough level would have a spacing of infliximab infusion.
The aim of our study is to compare an IFX infusion interval spacing strategy based on IFX trough level with an IFX infusion interval spacing strategy based on clinical evaluation for maintaining clinical and biological remission in IBD patients in deep remission.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- clinically-based spacing strategy, Trough level-based strategy
- 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.
clinically-based spacing strategyOther
All patients (as there are free from symptoms) will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission is maintained (CDAI < 150 for CD, Partial Mayo score < 3 for UC), patients will have a second step of a 2 weeks infliximab infusion spacing which will be maintained until the end of the study.
Trough level-based strategyOther
patients will have at inclusion a determination of the infliximab trough level. According to this dosage, only patients with a trough level ≥ 7 µg/ml will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission (CDAI < 150 for CD, Partial Mayo score < 3 for UC) is maintained and if infliximab trough level is still ≥ 7 ug/ml, patients will have a second step of 2 weeks infliximab spacing until the end of the study.
Patients with a baseline infliximab trough level < 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| clinically-based spacing | Other | All patients (as there are free from symptoms) after inclusion will have a spacing of their infliximab infusion interval which will be maintained until the end of the study. Receives: Other: clinically-based spacing strategy |
| Trough level-based spacing | Other | Only patients with a baseline infliximab trough level ≥ 7 ug/ml will have a spacing of their infliximab infusion interval which will be maintained until the end of the study. Patients with a baseline infliximab trough level < 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study. Receives: Other: Trough level-based strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of loss of clinical remission
mucosal Healing
Measured: 12 months
Rate of loss of biological remission
antidrug antibodies with detectable IFX trough levels
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 posted15 Feb 2019
- Study start26 Jun 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Why it stopped: difficulty of inclusion
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.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Pineton de Chambrun, Principal investigator, CHU of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841942
- Sponsor's protocol ID
- RECHMPL18_0024
- Acronym
- SPACIFIX
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2019
- Last updated
- 22 Jun 2026
- 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 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Trough Level-based Spacing and Clinical-based Spacing of Infliximab Infusions in Patients With Inflammatory Bowel Disease in Deep Remission; A Prospective, Multicenter, Open-label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT03841942
- Acronym / sponsor ID
- SPACIFIX / RECHMPL18_0024
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of inclusion
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 15 Feb 2019 (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.
Comparison of trough level-based spacing and clinical-based spacing of infliximab infusions in patients with inflammatory bowel disease in deep remission A prospective, multicenter, open-label, randomized, controlled Study
Detailed description
Infliximab (IFX) is common treatment for refractory inflammatory bowel disease (IBD) (5 mg/kg/8 weeks in maintenance). A large majority of IBD patients treated with IFX are currently in long-term clinical remission under maintenance IFX monotherapy or cotherapy with azathioprine or methotrexate. There is no recommendation on optimal duration of anti-TNF therapy once it is started. A key question is to know if the treatment could be stopped/decreased without clinical relapse. Anti-TNF therapy is also a major burden in health care costs in France. Identifying an optimal duration of anti-TNF therapy and criteria for stopping/decreasing could help in lowering these therapies cost without altering disease control. Prospective studies have investigated the withdrawal of IFX in IBD patients showing 50% of clinical relapse at 1 year in patient in clinical remission, 30% in patients in deep remission.
Another alternative to deescalate anti-TNF treatment would be to increase the infusion interval without stopping the drug. Indeed, this infusion interval spacing is strongly requested by patients who seek an improvement in their quality of life. This empirical spacing corresponded to an increase of the infusion interval to 10 weeks then to 12 weeks maximum in patients with persistent clinical remission. In France and in Europe, even if there is no recommendation about infliximab de-escalation and increase of the infusion interval, many physicians have already performed empirically an infliximab infusion interval spacing in IBD patients in longstanding remission while on infliximab maintenance therapy. This empirical infusion interval increase in patients in clinical remission leads to a clinical relapse in 30% of these patients with a median delay of 12.6 months (IQR: 10.4- 18.4) (Dufour et al. UEGW 2017).
Since the last ten years, it was demonstrated that the serum level of infliximab measured just before the last infliximab infusion (defined as a trough level) is correlated to the clinical activity of the disease1. A serum IFX trough level between 3 and 7 ug/ml has been identified as therapeutic with more clinical relapse in patients with IFX < 3 ug/ml and safe dose reduction in patients with IFX trough level > 7 ug/ml.
Thus, we hypothesized that using the determination of serum infliximab trough level could decrease the risk of clinical relapse observed in IBD patients who underwent an empirical infliximab infusion interval spacing (approximatively 30% of the cases). Indeed, in an infliximab trough level-based spacing strategy, only patients with a supratherapeutic (>7ug/ml) infliximab trough level would have a spacing of infliximab infusion.
The aim of our study is to compare an IFX infusion interval spacing strategy based on IFX trough level with an IFX infusion interval spacing strategy based on clinical evaluation for maintaining clinical and biological remission in IBD patients in deep remission.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clinically-based spacing | Other | Other: clinically-based spacing strategyAll patients (as there are free from symptoms) after inclusion will have a spacing of their infliximab infusion interval which will be maintained until the end of the study. |
| Trough level-based spacing | Other | Other: Trough level-based strategyOnly patients with a baseline infliximab trough level ≥ 7 ug/ml will have a spacing of their infliximab infusion interval which will be maintained until the end of the study. Patients with a baseline infliximab trough level < 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age greater than 18 years
Key exclusion criteria (12 listed)
- Subject unable to read or/and write
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 |
|---|---|---|
| clinically-based spacing strategyAll patients (as there are free from symptoms) will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission is maintained (CDAI < 150 for CD, Partial Mayo score < 3 for UC), patients will have a second step of a 2 weeks infliximab infusion spacing which will be maintained until the end of the study. | Other | clinically-based spacing |
| Trough level-based strategypatients will have at inclusion a determination of the infliximab trough level. According to this dosage, only patients with a trough level ≥ 7 µg/ml will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission (CDAI < 150 for CD, Partial Mayo score < 3 for UC) is maintained and if infliximab trough level is still ≥ 7 ug/ml, patients will have a second step of 2 weeks infliximab spacing until the end of the study. Patients with a baseline infliximab trough level < 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study. | Other | Trough level-based spacing |
Primary outcome
Rate of loss of clinical remission
Time frame: 12 months
mucosal Healing
Rate of loss of biological remission
Time frame: 12 months
antidrug antibodies with detectable IFX trough levels
Results and safety
The study was stopped early (reason given: difficulty of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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 Pineton de Chambrun principal investigator
CHU of Montpellier
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinically-based spacing strategy and Trough level-based strategy in people with Inflammatory Bowel Diseases, run by University Hospital, Montpellier at 16 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 14 inclusion and 12 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: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
The study was stopped early (reason given: difficulty of inclusion). 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?
Rate of loss of clinical remission (time frame: 12 months). The study lists 2 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 Jun 2026.