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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 18 August 2014
Main ID:  EUCTR2011-003038-14-BE
Date of registration: 03/01/2012
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: 30/03/2012
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: no Double blind: yes 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  
Phase: 
Countries of recruitment
Belgium Netherlands
Contacts
Name: Joos Evelyne   
Address:  Broekstraat 16 9070 Heusden Belgium
Telephone: 32477780202
Email: joos.evelyne@gmail.com
Affiliation:  BVBA JCP
Name: Joos Evelyne   
Address:  Broekstraat 16 9070 Heusden Belgium
Telephone: 32477780202
Email: joos.evelyne@gmail.com
Affiliation:  BVBA JCP
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 1 thiopurine; in which case AZA or 6MP will be continued: Patients previously intolerant to Azathioprine or 6-MP can start with the other thiopurine or with Methotrexate (MTX) per investigators discretion. Patient intolerant to standard doses of AZA or 6-MP can start at a lower dose per investigators discretion. However, the dose should remain stable for the duration of the trial, except if intolerance leading to discontinuation. ?
Patients failing MTX can continue on MTX with infliximab ?
Ongoing steroids are allowed if dose remains stable for at least 2 weeks, prior to screening until inclusion then tapered as per protocol 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 their current Azathioprine, 6-MP or MTX.
Adequate contraception for women of childbearing potential or their partner who must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last IFX treatment.

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
Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
Previous intolerance to Azathioprine and /or 6-MP or intolerance to one or both with impossibility to use the other drug or MTX (e.g. pancreatitis, severe leucopenia, hypersensitivity).
Ongoing infections
Prior use of biologic therapies
Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
Indication for immediate surgery
Critical gastrointestinal stricture with obstructive symptoms and/or presence of abscess.
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. Positive tuberculosis screen per local guidelines
Untreated latent tuberculosis (see national recommendations. Appendix 2), latent TB is allowed if treated for at least 6 months
Patients with moderate or severe heart failure
Patients with a history of hypersensitivity to infliximab, other murine proteins, or to any of the excipients.
HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
Azathioprine or 6-MP in combination with allopurinol or with other myelotoxic therapy (a washout period of 7 days is required for allopurinol or other myelotoxic therapy)
Non-compliant subjects.
Participation in another therapeutic study



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: Powder for solution 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)
Main Objective: To investigate whether sustained steroid-free remission between W22 and W54 and mucosal healing at 1 year can be achieved using IFX 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.
Primary end point(s): Proportion of patients with steroid-free remission between w22 and w54 (CDAI < 150) and endoscopic healing at W54 in CD patients treated with infliximab and azathioprine, 6MP or MTX using standard therapy or tailored treatment based on infliximab trough levels in addition to the usual clinical parameters.
Secondary Objective: - proportion of patients with sustained remission from week 14 onwards
- proportion of patients with sustained steroid free remission from week 14 onwards
- Proportion of patients with sustained IFX levels > 3 µg/ml
- clinical (CDAI) laboratory (hsCRP, Fecal calprotectin) and endoscopic status at all visits beyond week 14
Timepoint(s) of evaluation of this end point: week 54 after inclusion
Secondary Outcome(s)
Secondary end point(s): • Clinical remission (CDAI <150) at each visit and the whole study period
• Endoscopic evaluation at W12 and W54
o percentage of patients in each group with absence of ulcers;
o percentage of patients in each group with >50% improvement in CDEIS/SES-CD relatively to baseline (W0)
o percentage of patients in each group with CDEIS <3
• MR Enterography at week 0 and 54 at the centres where this procedure is standard of care with assessment of the Barcelona index.
• IFX Trough levels at each visit and every 4 weeks through the whole study period
• Fecal calprotectin and hsCRP levels at all visits
• Frequency of Adverse reactions (in specific infusion reaction and infections)
• Frequency of loss of response, defined as an increase of CDAI by 70 points compared to the previous measurement and elevated hsCRP or fecal calprotectin > 250. Frequency of flares hospitalizations and CD related surgeries
• Number and dose of co-medication
• Pharmaco-economic evaluation: disease and treatment related costs
• Correlations:
o mucosal healing vs. IFX levels
o mucosal healing vs. CRP
o mucosal healing vs. faecal calprotectin
Timepoint(s) of evaluation of this end point: Each visit
Week 0, week 12 and week 54 for endoscopic evaluation
Secondary ID(s)
2010-2
NCT01442025
Source(s) of Monetary Support
JANSEN Biologics
MSD
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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