To investigate whether sustained trough levels of IFX can be achieved using IFX (Infliximab) trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorithms in comparison with 'standard of care' IFX treatment and its effects on clinical and endoscopic outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
121
Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
Perfusion of IFX 5mg/kg or 7,5 mg/kg if dose increase criteria are met (biological)and 10mg/kg if dose increase criteria are met for a second time
Chu Amiens
Amiens, France
Chu Clermont-Ferrand
Clermont-Ferrand, France
Hopital Beaujon
Clichy, France
CHRU Lille
Lille, France
Level of remission
Proportion of patients with steroid-free remission (CDAI \< 150) and endoscopic healing (absence of ulcers) at week 54 CDAI = Crohn's Disease Activity Index
Time frame: 54 weeks after Inclusion
Clinical remission
Clinical remission (CDAI \<150) at each visit and the whole study period
Time frame: week 14 after inclusion
Endoscopic evaluation
* percentage of patients in each group with absence of ulcers; * percentage of patients in each group with \>50% improvement in CDEIS (Crohn's Disease Endoscopic Index Score
Time frame: week 0, week 12 and week 54
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CHU NICE
Nice, France
Hopital Saint Louis
Paris, France
CHU Bordeaux - Pessac
Pessac, France
Chu Reims
Reims, France
Chu Rennes
Rennes, France
Chu Toulouse
Toulouse, France
...and 2 more locations