Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSIO

Phase 1

• Conditions: This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes.Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with

• Registration Number: EUCTR2008-007519-34-SE
• Lead Sponsor: niversity of Leuven Hospitals, Division of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-02
• Study Completion: 2009-09-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Patients age 18-80 years
Mb Crohn disease or Ulcerative colitis or IBD
Already on infliximab therapy treated with one hour infusion
sustained clinical respone to infliximab

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
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Documentation of suspected immediated or delayed infusion reaction to previous infliximab infusion.
Prophylactic therapy before infliximab infusion to prevent infusion reaction including corticosteroids, antihistamines and acetaminophen.
Need for dose increase or decrease of interval below 6 weeks for loss of response
Dosing interval longer than 12 weeks in the previous 12 months
Known allergic reactions to any theraputic protein or to murine proteins
Any other contraindication to infliximabtherapy at the time of screening

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the tolerability and safety of 30 minutes Infliximab infusion;Secondary Objective: Proportion of patients with minor infusions reactions<br>Incidence and timing of seroius adverse events<br>Efficiacy of infliximab as defined as the proportion of patients interrupting therapy due to side effects or loss of response<br>Patients and nurses preference<br><br>;Primary end point(s): The proportion of patients with IBD who tolerates Infliximab infusions during 30 minutes