Inflammatory Bowel Diseases Clinical Trial
— SPACIFIXOfficial 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
Status | Recruiting |
Enrollment | 164 |
Est. completion date | April 26, 2025 |
Est. primary completion date | December 26, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | Amiens University Hospital | Amiens | |
France | Besançon University Hospital | Besançon | |
France | Bordeaux University Hospital | Bordeaux | |
France | Caen University Hospital | Caen | |
France | Clermont-Ferrand University Hospital | Clermont-Ferrand | |
France | Lille University Hospital | Lille | |
France | Pineton de Chambrun | Montpellier | |
France | CHRU Nancy - Hôpitaux de Brabois | Nancy | |
France | Nantes University Hospital | Nantes | |
France | Nice University Hospital | Nice | |
France | Nîmes University Hospital | Nîmes | |
France | APHP Beaujon Hospital | Paris | |
France | APHP Paris Cochin | Paris | |
France | Rennes University Hospital | Rennes | |
France | Saint Etienne University Hospital | Saint-Étienne | |
France | Toulouse University Hospital | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of loss of clinical remission | mucosal Healing | 12 months | |
Primary | Rate of loss of biological remission | antidrug antibodies with detectable IFX trough levels | 12 months |
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