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

• Conditions: uminal active Crohn's Disease; MedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2011-003038-14-BE
• Lead Sponsor: GETAID

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-03
• Last Update Posted: 18 August 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified