Luminal active Crohn's Disease MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: INFLIXIMAB
Product Name: INFLIXIMAB
Pharmaceutical Form: Suspension for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: INFLIXIMAB
Concentration unit
Sponsors
GETAID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age > 18 years - Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers. - Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria. - Patients must be naïve to thiopurines or have failed therapy with thiopurines (in which case AZA will be continued). - Ongoing steroids are allowed if at stable dose for at least 2 weeks and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day. - Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with azathioprine (2,5 mg/kg/day). Patients who develop AZA intolerance during the trial are continued in the trial without AZA (ie IFX monotherapy). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - Absence of endoscopically visible ulcers - Prior exposure to infliximab (other biologics allowed) - Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent - Previous intolerance to azathioprine leading to drug discontinuation - Ongoing infections - Positive tuberculosis screen per local guidelines - Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer - Indication for immediate surgery - Pregnant or breast-feeding woman. - Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools - Active tuberculosis - Untreated latent tuberculosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Proportion of patients in corticosteroid-free remission (no steroids beyond week 26), with endoscopic healing at week 54 and without surgery for the full year.;Timepoint(s) of evaluation of this end point: week 54 after inclusion;Main Objective: To investigate whether sustained trough levels of IFX can be achieved using IFX trough level measurements and adjustment of dosing based upon these levels by means of two different standardized algorythms in comparison with ‘standard of care’ IFX treatment and its effects on clinical and endoscopic outcomes;Secondary Objective: • Clinical remission (CDAI <150) at each visit and the whole study period • Endoscopic evaluation at week 0, 12 and 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Each visit for clinical remission Week 0, week 12 and week 54 for endoscopic evaluation;Timepoint(s) of evaluation of this end point: Each visit Week 0, week 12 and week 54 for endoscopic evaluation | — |
Countries
Netherlands
Contacts
Public ContactDETRE PATRICIA
GETAID
Outcome results
None listed