PhArmaCo-kinetics of InFliximab during treatment Inductio

Phase 1

• Conditions: Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-004618-10-BE
• Lead Sponsor: CUB- Hopital Erasme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-20
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Age > 18 years

Moderate-to-severe CD (HBI=8) with endoscopically visible ulcers or moderate-to-severe and severe UC (Mayo Score =6) and Mayo endoscopic subscore >1 (APPENDIX 1-2-3) (a patient with active disease without CRP can be included)

Patients must be starting on infliximab (Remicade (MSD) or CT-P13: Remsima (Mundipharma) or Inflectra (Hospira)) in accordance with national reimbursement criteria or a washout period of 8 weeks will be observed before starting any new anti-TNF therapy after vedolizumab and 4 weeks after adalimumab before starting infliximab

Patients may be naïve to thiopurines or have failed therapy with 1 thiopurine; in which case AZA or 6MP will be either continued or stopped: The dose must remain stable 4 weeks before beginning the study. 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 or AZA or 6MP can be stopped per investigators discretion. However, if the immunomodulator is continued or introduced during screening period, 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 was stable 2 weeks before beginning the study with a maximum of prednisone 16 mg/d or budesonide 9 mg/day and should be tapered in 2 weeks.

Patients who consent to receive 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

Women must have a contraceptive method

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 70
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 > 16 mg/d prednisolone or equivalent
Ongoing infections
Previous use of IFX
Prior use of biologic therapies excepted if a washout period of 8 weeks is respected
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, latent TB is allowed if treated for at least 6 months
Patients with moderate or severe heart failure
Patients with multiple sclerosis or lupus disease
Patients with a history of hypersensitivity to infliximab, or to any of the excipients
HIV, HBV, HCV 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