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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: 19 March 2012
Main ID:  EUCTR2008-007519-34-SE
Date of registration: 02/03/2009
Prospective Registration: Yes
Primary sponsor: University of Leuven Hospitals, Division of Gastroenterology
Public title: Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION
Scientific title: Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION
Date of first enrolment: 17/04/2009
Target sample size: 200
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007519-34
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase: 
Countries of recruitment
Sweden
Contacts
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Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder and solvent for solution for infusion

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

Secondary Outcome(s)
Secondary ID(s)
FAST VERSION
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
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