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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2008-007519-34-SE |
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Date of registration:
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02/03/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION
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Scientific title:
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Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION |
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Date of first enrolment:
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17/04/2009 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007519-34 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I):
Therapeutic exploratory (Phase II):
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Intervention(s)
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Trade Name: Remicade
Pharmaceutical Form: Powder and solvent for solution for infusion
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Primary Outcome(s)
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Main Objective: To assess the tolerability and safety of 30 minutes Infliximab infusion
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Primary end point(s): The proportion of patients with IBD who tolerates Infliximab infusions during 30 minutes
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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
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Secondary ID(s)
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FAST VERSION
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 17/04/2009
Contact:
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