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

• Register: EUCTR
• Last refreshed on: 3 July 2012
• Main ID: EUCTR2011-003038-14-NL
• Date of registration: 31/05/2012
• Prospective Registration: Yes
• Primary sponsor: GETAID
• Public title: A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE
• Scientific title: A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX
• Date of first enrolment: 21/06/2012
• Target sample size: 120
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-003038-14
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Same medical product at different dosage Number of treatment arms in the trial: 3

Countries of recruitment

Netherlands

Contacts

• Name: DETRE PATRICIA
• Affiliation: GETAID

• Name: DETRE PATRICIA
• Affiliation: GETAID

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Luminal active Crohn's Disease
MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Intervention(s)

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: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: • Clinical remission (CDAI <150) at each visit and the whole study period
• Endoscopic evaluation at week 0, 12 and 54

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

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Each visit
Week 0, week 12 and week 54 for endoscopic evaluation

Secondary end point(s): Each visit for clinical remission
Week 0, week 12 and week 54 for endoscopic evaluation

Secondary ID(s)

2010-2

Source(s) of Monetary Support

Janssen Biologics

MERCK