Study Investigating Tailored Treatment With Infliximab for Active Crohn's Disease (TAILORIX)

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Completed; Phase 4

Conditions: Crohn's Disease

Treatments: Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT01442025

GETAID 2010-2

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

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 (see national recommendations. Appendix 2).
• Non-compliant subjects.
• Participation in another therapeutic study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 3 patient groups, including a placebo group

Cohort 1 =Control Group

Placebo Comparator group

Description:

the dose of IFX will be increased by 5 mg/kg (maximally 1 time) based on symptom relapse (usual clinical practice) Dose will be kept stable ofr the rest of the trial Dose decreases will not be allowed.

Treatment:

Drug: Infliximab

Drug: Infliximab

Drug: Infliximab

Cohort 2

Active Comparator group

Description:

Dose of IFX will be increased by 2.5 mg/kg (maximally 2 times) if the following criteria are met A dose increase is maintained for the following infusions

Treatment:

Drug: Infliximab

Drug: Infliximab

Drug: Infliximab

Cohort 3

Active Comparator group

Description:

Dose of IFX will be increased by 5 mg/kg (maximally 1 time) if the following criteria are met A dose increase is maintained for the following infusions

Treatment:

Drug: Infliximab

Drug: Infliximab

Drug: Infliximab