A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX

GETAID0 个研究点目标入组 120 人开始时间: 2012年5月31日最近更新: 2012年7月3日

适应症

试验速览

暂无简介。

•- 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

•- 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

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