Status:
TERMINATED
Comparison of Trough Level- and Clinical-based Spacing of Infliximab Infusions in Patients With IBD in Deep Remission
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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, random...
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03841942
Start Date
June 26 2019
End Date
October 31 2023
Last Update
June 13 2024
Active Locations (16)
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1
Amiens University Hospital
Amiens, France
2
Besançon University Hospital
Besançon, France
3
Bordeaux University Hospital
Bordeaux, France
4
Caen University Hospital
Caen, France